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Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments
Bora Pharmaceuticals Adds Roller Compaction Capabilities
Installed at Zhunan, Taiwan facility known for manufacturing complex oral solid dose formulations.Tim Wright, Editor, Contract Pharma 04.09.21
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Breaking News | Clinical Trials | CRO News | Drug Development
Moleculin Selects IQVIA Biotech to Advance COVID Treatment
IQVIA to manage the company's effort to begin potential clinical trials of WP1122 for the treatment of COVID-19.Kristin Brooks 04.06.21
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Breaking News | Industry News | Information Technology
LabVantage Solutions Expands and Improves its Portfolio
Unveils two new solutions and an updated version of its flagship LIMS platform.Charles Sternberg, Assistant Editor 04.05.21
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Biologics, Proteins, Vaccines | Regulatory Affairs
What Will Change at FDA for 2021?
(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
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Drug Delivery
The Ever-Evolving World of Combination Products
Looking at the benefits and challenges of the trend towards combination products.Ricki A. Chase, M.S, Lachman Consultants 04.01.21
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Clinical Trials | Drug Development | QA/QC
RBQM Comes of Age: COVID as a Catalyst for Change
Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.Kristin Brooks, Managing Editor 04.01.21
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Breaking News | Drug Development
Servier Acquires Agios Pharmaceuticals’ Oncology Portfolio
Expands its oncology leadership capabilities in the U.S.Charles Sternberg, Assistant Editor 04.01.21
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Breaking News | Industry News | Promotions & Moves
Vibalogics Updates U.S. Leadership Team
Appoints new CFO, VP of quality and head of process sciences.Charles Sternberg, Assistant Editor 03.31.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Drug Development | Facilities | Industry News
Chime Biologics Expands CDMO Capabilities
Completes $190 million financing round to accelerate capacity expansion.Tim Wright, Editor, Contract Pharma 03.29.21
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Clinical Trials | Drug Development
Regulatory Practices in a Post-Pandemic World
Envisioning the new normal for clinical development.Dr. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 03.22.21
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Breaking News | Clinical Trials | Drug Development | Trials & Filings
Gilead, Novo Nordisk Expand NASH Alliance
Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.Kristin Brooks 03.18.21
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Breaking News | Clinical Trials | Drug Development | Trials & Filings
Cytocom Gets FDA Clearance for Phase II Trial of COVID Immune Therapy
Phase 2 clinical trial to evaluate the safety and efficacy of CYTO-205 as a treatment to slow or halt the progression of SARS-CoV-2.Kristin Brooks 03.16.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News
Tevogen Bio, BioCentriq Partner for COVID T-cell Therapy
NJ-based cell and gene therapy development and manufacturing center to support clinical manufacturing of Tevogen’s investigational COVID-19 treatment.Kristin Brooks 03.16.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
BioVaxys, Wuxi Biologics Enter Bioproduction Agreement
To synthesize proteins for SARS-CoV-2 vaccine and COVID-T immunodiagnostic programs.Tim Wright, Editor, Contract Pharma 03.15.21
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Clinical Trials | Information Technology
The Evolution of Clinical Research Technology to Support Remote Collaboration
Pioneering change with technology advancements that yield high reward with tolerable risk.Angela Gill Nelms, COO for Florence Healthcare 03.11.21
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Breaking News | Capsules | Industry News
CapsCanada Launches Liquid-Filled Hard Capsule Mfg. Service in North America
New service aims to return pharmaceutical and OTC drug manufacturing back to North America.Kristin Brooks 03.10.21
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Breaking News | Trials & Filings
Lilly's COVID Therapy Boasts Robust New Results
Phase 3 trial data shows bamlanivimab and etesevimab reduces the risk of COVID-related hospitalization and death by 87%.Kristin Brooks 03.10.21
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Jubilant HollisterStier, Lilly Enter Bamlanivimab Mfg. Pact
COVID-19 therapy Bamlanivimab will be manufactured at Jubilant HollisterStier's Spokane, WA facility.03.09.21
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Breaking News | Industry News
FDA Grants Tentative Approval to Generic Version of Symbicort
Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).Charles Sternberg, Assistant Editor 03.09.21
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cGMP Manufacture | Process Development | Scale-up/Technology Transfer
Process Intensification: Understanding the Optimal Way to Maximize Productivity
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius 03.09.21
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Breaking News | Drug Delivery | Facilities | Industry News | Packaging & Tracking
Vectura Expands Dry Powder Inhaler Capabilities
Bolsters development and manufacturing capabilities at its facility in Chippenham, U.K.Tim Wright, Editor, Contract Pharma 03.09.21
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Breaking News | cGMP Manufacture | Industry News | Inspections
Metrics Contract Services Completes Russian Regulatory Inspection
Greenville, NC site approved to make an oncology drug to be marketed in Russia.Tim Wright, Editor, Contract Pharma 03.09.21
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Breaking News | Clinical Trials
Strata Oncology Unveils Strata PATH Trial
The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data.Charles Sternberg, Assistant Editor 03.02.21
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Information Technology
5 Reasons Paper Has No Place in Contract Manufacturing
Digital solutions create more efficient manufacturing processes and eliminate delays.Dave Edwards, Chief Revenue Officer, MasterControl 03.01.21
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Drug Delivery | Parenterals
Injectable Drug Delivery Trends
How medication trends are driving the shift to patient-friendly drug delivery systems.Peter Soelkner, Managing Director, Vetter 03.01.21
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Cold Chain Management | Logistics | Packaging & Tracking | Supply Chain
Reshaping the Pharmaceutical Supply Chain
The pandemic and COVID-19 vaccines bring navigating the cold-chain and preserving precious biologics to the forefront.Kristin Brooks, Managing Editor 03.01.21
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Breaking News | Industry News
J&J’s Single-Dose COVID-19 Vax Issued EUA
Phase 3 ENSEMBLE study demonstrated the vaccine was 85 percent effective in preventing severe disease.Kristin Brooks 03.01.21
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Breaking News | Collaborations & Alliances | Industry News
Phlow Corp. and USP Form Alliance
Focused on continuous manufacturing to increase supply of essential medicines for U.S. patients.Tim Wright, Editor, Contract Pharma 03.01.21
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Breaking News | Industry News
Thermo Fisher Scientific Completes Mesa Biotech Acquisition
Becomes part of the Life Sciences Solution Segment and is expected to add revenue of approximately $200 million in 2021.Kristin Brooks 02.26.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
Joins network of approved manufacturers of lipid excipients for Pfizer-BioNTech COVID-19 vaccine.Tim Wright, Editor, Contract Pharma 02.25.21
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Bioanalytical Services | Breaking News | Industry News | Preclinical Outsourcing
Altasciences Contributes to Vibegron Approval
Provided clinical support for two drug-drug interaction studies and a bioavailability trial for the overactive bladder treatment.Kristin Brooks 02.24.21
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Breaking News | Drug Development | Industry News
Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
Sentynl acquires CUTX-101 Copper Histidinate for the treatment of Menkes disease for $20 million in upfront and regulatory milestones.Kristin Brooks 02.24.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News | Information Technology
Pfizer Selects Seven Bridges to Support RNA Sequencing Data
Seven Bridges will centralize and manage terabytes scRNASeq data, which provides detailed analysis of gene expression in individual cells.Kristin Brooks 02.24.21
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Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments
Glatt and Aprecia Enter 3D-Printing Collaboration
Aprecia's compression-free 3DP manufacturing platform expands Glatt capabilities in innovative particle design.Tim Wright, Editor, Contract Pharma 02.23.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Kaneka Eurogentec Expands Capabilities
Receives GMP accreditation for new mRNA manufacturing facility, COVID-19 vaccine production ongoing.Tim Wright, Editor, Contract Pharma 02.17.21
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Biologics, Proteins, Vaccines | Collaborations & Alliances | Drug Development
Molecular Templates, BMS Enter Strategic Research Pact
Aims to discover and develop multiple therapies for specific oncology targets utilizing MTEM’s next-gen engineered toxin body (ETB) platform.Kristin Brooks 02.11.21
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Breaking News | Facilities | Industry News
Scapa Healthcare Enhances OTC Drug Manufacturing Capabilities
Makes multimillion dollar investment at its Knoxville facility.Tim Wright, Editor, Contract Pharma 02.10.21
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Biologics, Proteins, Vaccines | Breaking News
RotaChrom Technologies Partners with Cyclolab
Aims to develop a more efficient and cost-effective process to purify Remdesivir, a widely used treatment option for COVID-19.Charles Sternberg, Assistant Editor 02.09.21
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Trials & Filings
FDA Approves BMS CAR-T Cell Therapy
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory large B-cell lymphoma.Kristin Brooks 02.08.21
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Breaking News | Industry News | Promotions & Moves
AMRI Makes Executive Move
Appoints Scott Waldman to lead corporate development.Tim Wright, Editor, Contract Pharma 02.08.21
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Breaking News | Facilities | Fill/Finish | Industry News | Lyophilization | Parenterals
Argonaut Opens Custom Controls and Standards Facility
Formulation and filling will be performed at a state-of-the-art site in Carlsbad, CA.Tim Wright, Editor, Contract Pharma 02.08.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Paragon Biosciences Expands Cell and Gene Therapy Platform
Launches CiRC Biosciences with an initial focus on developing eye disease treatments.Tim Wright, Editor, Contract Pharma 02.08.21
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Biologics, Proteins, Vaccines | Clinical Trials
Inside a COVID Vaccine Trial
Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.Kristin Brooks, Managing Editor 02.05.21
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Breaking News | Financial Reports
Financial Report: Lilly
Recognizes worldwide revenue of $871.2 million in the quarter for bamlanivimab COVID-19 treatment.Kristin Brooks 02.05.21
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Breaking News | Financial Reports
Regeneron 4Q and FY20 Results
REGEN-COV antibody cocktail for COVID-19 received FDA EUA; Net sales of REGEN-COV were $146 million in the quarter and $186 million for the year.Kristin Brooks 02.05.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Trials & Filings
J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate
Plans to distribute vaccine to U.S. government immediately following authorization, and expects to supply 100 million doses in 1H21.Kristin Brooks 02.05.21
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Cold Chain Management | Logistics | Supply Chain
Delivering Custom Client Solutions
Cold chain solutions provider Sentry BioPharma Services is able to adapt to meet the diverse needs of its clients.Contract Pharma Staff
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Drug Discovery | Industry News | Information Technology
Evozyne, Takeda Ink Strategic Protein Design Agreement
Takeda will use Evozyne's evolution-based protein design technology to research and develop proteins for next-gen gene therapies.Kristin Brooks 01.28.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
Lilly, Vir, GSK Partner to Evaluate COVID Combo Therapies
Lilly expands BLAZE-4 trial to evaluate bamlanivimab with VIR-7831, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein.Kristin Brooks 01.27.21
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Clinical Trials | Information Technology
The State of Clinical Trial Technology
Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.Kristin Brooks, Contract Pharma 01.26.21
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Breaking News | Formulation Development | Industry News | Methods Development
Adare Pharma Solutions Opens New Small-Scale Lab
Vandalia, OH lab offers customizable, flexible systems designed to expedite formulation and process development services.Kristin Brooks 01.26.21
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Breaking News | Capsules | Cold Chain Management | Fill/Finish | Industry News | Solid Dosage/Semi-solids
Aphena’s $21M Cookeville Expansion Nears Completion
Bottle packaging capacity has been expanded with the installation of 10 high-speed bottling lines to start.Kristin Brooks 01.26.21
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Breaking News
500+ Sites Join Inato’s Industry Marketplace
Platform aims to make clinical research more inclusive and efficient.Charles Sternberg, Assistant Editor 01.26.21
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Breaking News | Facilities | Industry News | Injectables | Parenterals
Civica to Build an Essential Medicines Manufacturing Facility in Virginia
Will produce sterile injectable meds used in hospitals for COVID-19 patient care.Tim Wright, Editor, Contract Pharma 01.25.21
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Breaking News | Industry News
Pfizer, BioNTech Enter Vax Pact with COVAX
Initial agreement provides up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine to COVAX in 2021, with first deliveries expected in 1Q21.Kristin Brooks 01.22.21
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Breaking News | Trials & Filings
FDA Approves Janssen’s CABENUVA
Becomes first and only once-monthly, long-acting regimen for the treatment of HIV infection.Kristin Brooks 01.22.21
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Breaking News | Promotions & Moves
Eisai Appoints Chief Clinical Officer of Oncology Biz
Dr. Richard Woodman has 18 years of pharmaceutical experience in several different functional areas at both large and small biotech organizations.Contract Pharma Staff 01.20.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
JS Bio and Etta Biotech Advancing Partnership
Will set up a high titer transient protein expression platform for high quality protein production.Contract Pharma Staff 01.19.21
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Breaking News | Collaborations & Alliances | Drug Discovery
Metrion, LifeArc Extend Neuroscience Alliance
Collaboration extended for another 12 months after successfully progressing into late stage hit-to-lead optimization phase.Contract Pharma Staff 01.18.21
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Precision Medicine Group Acquires Project Farma
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.Contract Pharma Staff 01.14.21
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Delivery | Facilities | Industry News | Solid Dosage/Semi-solids
Catalent Acquires Acorda’s INBRIJA Manufacturing Operations
The CDMO pays $80 million for dry powder inhaler spray drying, capsule manufacturing and packaging operations in Boston area.Contract Pharma Staff 01.13.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News | Process Development
Capricor, Lonza Enter CAP-1002 Development Agreement
Lonza will perform process development activities for late-clinical and commercial-scale GMP manufacturing of CAP-1002.Contract Pharma Staff 01.12.21
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Biologics, Proteins, Vaccines | Breaking News | Drug Delivery | Industry News
iosBio Inks Exclusive Vax Platform Pact for COVID-19
OraPro oral delivery vaccine platform technology enables oral administration of thermally-stable, viral vector vaccines.Contract Pharma Staff 01.12.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Parenterals
Irisys Receives NIH Contract for the Formulation of Drinabant
Seeks to develop a drug for treatment of acute cannabinoid overdose.Contract Pharma Staff 01.11.21
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The Changing R&D Landscape
Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs)
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
MilliporeSigma Acquires AmpTec
Expands mRNA capabilities for vaccines, treatments and diagnostics.Contract Pharma Staff 01.07.21
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Clinical Trials | Drug Development
The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs
Appropriate adaptive designs in early stages of development can accelerate timelines and reduce costs, and help focus on the most promising agents.Jürgen Hummel, MSc, Senior Director, Statistical Science, PPD, and Lead of PPD’s Adaptive Design Working Group 01.07.21
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Breaking News | Clinical Trials | Promotions & Moves
Parexel Appoints Chief Patient Officer
Demonstrates the company’s commitment to elevating the patient perspective.Contract Pharma Staff 01.06.21
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Breaking News | Collaborations & Alliances | Industry News
Angelini Pharma Acquires Arvelle Therapeutics for $960M
Angelini to become a leader in CNS and mental health disorder treatments; opening direct affiliates in France, UK, Nordics and Switzerland by 2022.Contract Pharma Staff 01.05.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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Analytical Services | Biologics, Proteins, Vaccines | Clinical Trial Materials | Laboratory Testing
Samsung Biologics Continues to Leverage Digitalization to Optimize Client Experience
Through digital transformation, Samsung Biologics is innovating how they connect with clients, regulatory bodies and industry professionals.
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Breaking News | Industry News | Trials & Filings
Moderna Wins FDA Authorization for COVID-19 Vax
The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.Contract Pharma Staff 12.21.20
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Breaking News | Packaging & Tracking
Aptar CSP Increases Capacity for Active Packaging Solutions
3-Phase Activ-Polymer platform technology protects electrochemical, lateral flow, and molecular diagnostic test kits.Contract Pharma Staff 12.17.20
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APIs | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Aurinia and Lonza Expand Manufacturing Partnership
Form agreement for voclosporin manufacturing capacity.Contract Pharma Staff 12.16.20
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Clinical Trials | Drug Development | Information Technology
Advancing Digital Endpoints in Clinical Trials
An end-to-end approach to managing wearable devices through clinical development.Kristin Brooks, Contract Pharma 12.14.20
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Drug Development
Navigating Uncertainty: Considerations for Life Sciences 2021
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP 12.11.20
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Breaking News | cGMP Manufacture | Drug Development | Industry News | R&D
Ascentage Selects PharmaBlock as Preferred Provider
PharmaBlock will support Ascentage in accelerating its drug development pipeline with R&D, manufacturing capacity, and technological solutions.Contract Pharma Staff 12.11.20
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Breaking News | Industry News
Gilead to Acquire MYR GmbH for €1.15B
Gains Hepcludex, a first-in-class treatment for HDV; anticipates accelerated global launch as a result of the acquisition.Contract Pharma Staff 12.10.20
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Breaking News | cGMP Manufacture | Fill/Finish | Industry News | Parenterals
Thermo Fisher Scientific Further Expands Global Footprint
Will expand sites in Greenville, NC; Swindon, UK; and Ferentino and Monza, Italy for sterile drug product development and commercial manufacturing.Contract Pharma Staff 12.10.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
atbtherapeutics, iBio CDMO Enter Manufacturing Agreement
Will work together for the industrialization of the GMP manufacturing process of atbtherapeutics’ atbodies.Contract Pharma Staff 12.09.20
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Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Sesen Bio Enters Mfg. and Supply Partnership with Qilu Pharma
Technology transfer to Qilu anticipated to be completed in mid-2021.Contract Pharma Staff 12.09.20
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
Lilly, UnitedHealth to Study Bamlanivimab in High-risk COVID-19
The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions.Contract Pharma Staff 12.04.20
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Pfizer, BioNTech Submit CMA for Covid-19 Vax to EMA
Approval could potentially enable the use of BNT162b2 in Europe before the end of 2020.Contract Pharma Staff 12.01.20
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Breaking News | Collaborations & Alliances | Drug Discovery | Industry News
Syngene and 3DC Sign 5-year Collaboration
Partner on discovery projects, from target validation through to pharmacological proof of concept and preclinical evaluation.Contract Pharma Staff 11.24.20
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Drug Delivery | Drug Development
Inhaled Drug Delivery Technology Trends
The success of new inhaled medicines relies on the correct combination of formulation and device technology.Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20
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Breaking News | Drug Development | Trials & Filings
Regeneron's COVID-19 Antibody Cocktail Gets EUA
Expects to have treatment doses ready for approximately 80,000 patients by the end of November, and 200,000 by the first week of January.Contract Pharma Staff 11.23.20
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Breaking News | cGMP Manufacture | Industry News
Catalent, Blueprint Enter GAVRETO Commercial Supply Pact
Following FDA approval and tech transfer, the Catalent team in Kansas City will support commercial supply of the non-small cell lung cancer drug.Contract Pharma Staff 11.23.20
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Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
ARCA Biopharma’s AB201 for COVID-19 Gets Fast Track
Initiation of ASPEN-COVID-19 Phase 2b clinical trial anticipated in December with trial data anticipated 2Q21.Contract Pharma Staff 11.23.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Collaborations & Alliances | Industry News
Pfizer and BioNTech to Submit EUA for COVID-19 Vaccine
Expect to produce globally up to 50 million doses in 2020, up to 1.3 billion doses by the end of 2021; ready to distribute within hours after authorization.Contract Pharma Staff 11.20.20
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Breaking News | Industry News | Information Technology | Promotions & Moves
Sharp Implements Cloud-Based QMS
Strengthens quality leadership with new appointments.Contract Pharma Staff 11.18.20
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Trials & Filings
Pfizer, BioNTech Conclude Phase III COVID-19 Vax Study
Meets all primary efficacy endpoints, demonstrates BNT162b2 to be 95% effective against COVID-19.Contract Pharma Staff 11.18.20
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APIs | Breaking News | Industry News
Almac Gets Grant From COVID-19 Therapeutics Accelerator
Will work to enable efficient manufacturing of remdesivir in Response to COVID-19.Contract Pharma Staff 11.18.20
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Cell & Gene Therapy Supply Chain: Early Preparation is Key
Supply chain management for cell and gene therapies requires precise demand planning and forecasting.Matthew Farabaugh, Chief Financial Officer, The Discovery Labs 11.17.20
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Injectables Firms Expand Capacity
CDMOs see steriles demand grow.S. Harachand, Contributing Editor 11.17.20
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Excipients
Bye-Bye China?
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.Michele Jermini and Enrico Polastro 11.17.20
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Clinical Trials | Information Technology | R&D
Decentralized Trials Fuel AI Revolution in Clinical Research
The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20
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Scale-up/Technology Transfer
Ensuring Quality During the Transfer and Scale Up of Rx Drugs
Defining the key parameters and considerations for a successful technology transfer.Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd. 11.17.20
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Breaking News | Collaborations & Alliances | CRO News
PathoQuest, Charles River Expand Strategic Pact
Establishes a biologics genomic testing laboratory in Wayne, PA to expand next-generation sequencing capabilities.Contract Pharma Staff 11.12.20
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Financial Reports
Financial Report: Merck
Pharmaceutical sales were up 2% to $11.3 billion in the quarter, driven primarily by growth in oncology and certain hospital acute care products.Contract Pharma Staff 11.04.20
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Breaking News | Financial Reports
Financial Report: Gilead
Veklury (remdesivir) revenues were $873 million in the third quarter.Contract Pharma Staff 10.28.20
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Breaking News | Drug Development | Trials & Filings
Gilead’s Remdesivir Wins FDA Approval to Treat COVID-19
Veklury is now the first and only approved COVID-19 treatment in the U.S.Contract Pharma Staff 10.23.20
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Biologics, Proteins, Vaccines | Breaking News
FDA Issues Guidance on EUA for COVID-19 Vaccines
Provides further information on the EUA process for investigational vaccines.Contract Pharma Staff 10.07.20
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
FibroGenesis Collaborates with R4D Biotech
Expands the fight against COVID-19 in Brazil.Contract Pharma Staff 10.02.20
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine
Recruitment for the Phase 1 clinical study is expected to start this month.Contract Pharma Staff 09.16.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Managing Editor 09.09.20
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Clinical Trials | Drug Development
FDA Response to COVID-19
A Discussion on Protocol Amendments and Clinical Study Reports in Affected Ongoing Trials.Jack Modell, M.D., Vice President and Senior Medical Officer, Rho 09.03.20
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Breaking News | Trials & Filings
FDA Clears SPI’s Ebselen for Phase II COVID-19 Trials
SPI-1005 is a novel anti-inflammatory drug which was recently shown to inhibit nCoV2 activity and viral replication.Contract Pharma Staff 08.31.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Contract Pharma 08.25.20
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Breaking News | Facilities | Industry News | Inspections
FDA Approves Romark Facility in Puerto Rico
The facility is equipped to produce tablets, powders and other oral solid dosage forms.Contract Pharma Staff 08.24.20
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Breaking News | Trials & Filings
FDA Approves Roche’s Tecentriq Combo for Melanoma
Tecentriq with Cotellic and Zelboraf helped people live longer without disease worsening or death compared to placebo.Contract Pharma Staff 07.31.20
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Breaking News | cGMP Manufacture | Laboratory Testing
Alcami Site Expansion Nears Completion
GMP Laboratory testing will begin this month.Contract Pharma Staff 07.31.20
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APIs | Breaking News | Industry News
ChemWerth Files its 500th Drug Master File with FDA
API supplier supports both large and small finished dosage companies worldwide.Contract Pharma Staff 07.23.20
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Breaking News | Collaborations & Alliances | Industry News
Patheon to Manufacture FDA-Approved Nasal Spray
Evoke Pharma initiates commercial manufacturing of Gimoti with the CDMO.Contract Pharma Staff 07.17.20
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Breaking News | Collaborations & Alliances | Industry News
Moleculin Enters Agreement with Sterling Pharma
Will produce WP1122 for potential treatment of COVID-19.Contract Pharma Staff 07.15.20
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Drug Development | Trials & Filings
FDA Approves Expanded Use for BOTOX
For the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.Contract Pharma Staff 07.10.20
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Pii Gets Registered as a Part of the FDA’s 503B Solution
Added to the list of organizations officially registered as human drug outsourcing facilities.Contract Pharma Staff 07.06.20
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Breaking News | Industry News
ADMA Biologics Opens New Plasma Collection Facility
Aims to open 5 to 10 more collection centers by the end of 2022.Contract Pharma Staff 07.06.20
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EMD Serono, Pfizer Win FDA Approval for sBLA for BAVENCIO
For the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.Contract Pharma Staff 07.01.20
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Breaking News | Industry News
FDA Issues EUA to HymonSARS-CoV-2 Test Kit for Detection of COVID-19
SpectronRx and HymonBio expect to produce 10 million tests per month for labs around the world.Contract Pharma Staff 06.18.20
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Breaking News
Lupin Pharmaceuticals Recalls One Lot of Metformin Hydrochloride Extended-Release Tablets
The product was found to more than the acceptable amount of NDMA, a carcinogen.Contract Pharma Staff 06.11.20
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Breaking News | Drug Development
FDA Grants Orphan Drug Designation for Brain Cancer Drug Berubicin
Accelerates its development to treat malignant gliomas and provides CNS with the potential for market exclusivity.Contract Pharma Staff 06.11.20
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Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
Aspargo Laboratories Completes Pre-IND Meeting with FDA
Collaborating with the CDMO Pii to develop and manufacture Sildenafil Oral Spray for clinical trialsContract Pharma Staff 06.08.20
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Aetion Launches Research Collaboration with FDA
Aims to advance understanding of COVID-19.Contract Pharma Staff 05.20.20
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Virpax Completes Pre-IND Meeting with FDA on Epoladerm
To pursue a 505(b)(2) New Drug Application for Epoladerm in osteoarthritis of the knee.Contract Pharma Staff 05.20.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News
bluebird bio Amends CAR-T Collaboration
Bristol Myers Squibb assumes responsibility for vector manufacturing in ex-U.S. territoriesContract Pharma Staff 05.18.20
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Breaking News | Facilities | Industry News | Inspections
PharmaCyte Conducts Final Audit of Mfg. Facility
Batch records in Thailand have been deemed cGMP compliantContract Pharma Staff 05.18.20
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Breaking News | Industry News | Laboratory Testing
Thermo Fisher Gets Expanded EUA for SARS‑CoV‑2 Test
This third expansion further increases the number of high-throughput PCR instruments that labs can use to run tests.Contract Pharma Staff 05.13.20
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Breaking News | Collaborations & Alliances | Industry News
Sorrento, Mount Sinai to Develop COVI-Shield Antibody Therapy
Targets SARS-CoV-2 infection (COVID-19) with an antibody cocktailContract Pharma Staff 05.12.20
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
HJB, Mabspace Ink Development and Manufacturing Agreement
Program aims to bring more efficacious treatment options to cancer patientsContract Pharma Staff 05.12.20
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Breaking News | Industry News
FDA COVID-19 Update
Authorizes the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testingContract Pharma Staff 05.11.20
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
Catalent Provides Clinical Support for COVID-19 Study
Partners with Humanigen for FDA-approved Phase 3 lenzilumab study for COVID-19 patientsContract Pharma Staff 05.08.20
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Analytical Services | Breaking News | Risk Management
CluePoints Tech Benefits Clinical Studies Affected by COVID-19
Its COVID-19 risk assessment package and Data Surveillance solution is being utilized in over 200 ongoing studies.Contact Pharma Staff 05.07.20
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Breaking News | Collaborations & Alliances | Industry News | Information Technology
Quartic.ai Partners with Bright Path Labs
Collaborate to develop AI-powered continuous manufacturing of critical APIs for medicinesContract Pharma Staff 05.06.20
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Breaking News | Collaborations & Alliances | Industry News
BARDA Funds Development of Tangen Biosciences’ Multi-Target Platform
Also awards Tangen a new contract for Point-of-Care COVID-19 molecular testContract Pharma Staff 05.06.20
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Breaking News | Collaborations & Alliances | Industry News
AGC Biologics Inks Manufacturing Deal with Faron
The CDMO will manufacture novel precision cancer immunotherapy treatment ClevegenContract Pharma Staff 05.06.20
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Speeding Vaccine Development with Advanced Analytics
Having immediate access to wide ranging resources of data can help speed the COVID-19 vaccine development processDr. Shlomi Madar, VP of Healthcare Solutions, Signals Analytics 05.05.20
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HCQ Comes Center Stage
Indian players ramp up chloroquine productionS. Harachand, Contributing Editor 05.05.20
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Breaking News | cGMP Manufacture | Fill/Finish | Industry News
Aji Bio-Pharma, CytoDyn Enter COVID-19 Mfg. Pact
Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patientsContract Pharma Staff 05.05.20
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Breaking News | Industry News
AMRI Increases HCQ Production in U.S.
Ready to meet potential COVID-19 demandContract Pharma Staff 05.04.20
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Breaking News | Industry News
Gilead Granted EUA for Remdesivir in COVID-19
Facilitates broader use of remdesivir to treat hospitalized patients with severe COVID-19 diseaseContract Pharma Staff 05.01.20
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Industry News | Regulatory Affairs
FDA COVID-19 Update
Issues guidance highlighting flexibility under the Drug Supply Chain Security ActContract Pharma Staff 05.01.20
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cGMP Manufacture | Drug Development
Accelerating Life-Saving Drugs to Market During COVID-19 Pandemic
Streamlining drug development with CDMOsMasha Kononov, Senior Director Emerging Pharma, USA, Arcinova, and Stephen Brown, Pharmaceutical and Biotech Consultant 05.01.20
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Scale-up/Technology Transfer
Moderna, Lonza Enter COVID-19 Vaccine Mfg. Pact
Aims to enable manufacturing of up to 1 billion doses per year with first batches of mRNA-1273 expected to be manufactured at Lonza U.S. in July 2020Contract Pharma Staff 05.01.20
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
Valneva Collaborates with Pfizer On Lyme Disease Vaccine
VLA15 is being evaluated for adult and pediatric indications in North America and EuropeContract Pharma Staff 04.30.20
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Breaking News | Drug Development | Industry News
Supernus Acquires US WorldMeds’ CNS Portfolio
Adds three marketed products in the U.S. and a product candidate in late-stage development.Contract Pharma Staff 04.29.20
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Breaking News | Industry News
Genalyte Launches High-Speed COVID-19 Antibody Test
First instrument-based, rapid test uses multi-antigen approach; U.S. FDA EUA submittedContract Pharma Staff 04.28.20
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Breaking News | Industry News
FDA COVID-19 Update
FDA issues a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquineContract Pharma Staff 04.27.20
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APIs | Breaking News | Industry News | Supply Chain
FDA Releases Coronavirus Supply Chain Update
Manufacturer alerts FDA to a shortage of a drug related to site affected by coronavirus03.02.20
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Breaking News | Industry News | Inspections | QA/QC | Regulatory Affairs
FDA Provides Update on Activities Related to Coronavirus
Says it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the world02.25.20
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Drug Development
Major Drug Approvals of 2019
Abbvie, Novartis, Pfizer and J&J score big wins with blockbuster potentialKristin Brooks, Contract Pharma 02.24.20
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Breaking News | Clinical Trials | CRO News | Drug Development | Regulatory Affairs
Parexel Launches Regulatory & Access Consulting Organization
Alignment of these capabilities aims to save time and resources across the drug development lifecycle01.10.20
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Breaking News | Drug Development | Industry News
Lilly to Acquire Dermira
Expands Lilly's immunology pipeline with the addition of lebrikizumab, a Phase III monoclonal antibody to treat atopic dermatitis01.10.20
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APIs | Breaking News | cGMP Manufacture | CRO News | Drug Development | Facilities | Industry News
Alcami Sells Netherlands Site to MerachemSyncom
Expands portfolio of chemistry services from compound design to clinical proof of concept.01.09.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News | Injectables | Parenterals
Hikma and Arecor Enter Injectables Alliance
Form agreement to develop and commercialize ready-to-use medicine using Arestat technology.01.09.20
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
ADMA Biologics Enters Mfg. and Supply Agreement
To produce and sell plasma-derived intermediate fractions.01.07.20
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Breaking News | Promotions & Moves
CARsgen Therapeutics Appoints Global Regulatory Affairs SVP
Dr. Fan will be responsible for CARsgen global regulatory strategy, leading the U.S. and China regulatory affairs team01.06.20
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Clinical Trials | CRO News | Drug Development | Industry News | Information Technology
Janssen, PRA Design First Mobile Virtual Trial
Kent Thoelke and Greg Licholai of PRA discuss the alliance, advances that have made virtual clinical trials possible, and the obstacles that remainKristin Brooks, Contract Pharma 01.06.20
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APIs | Breaking News | Facilities | Industry News
WuXi STA Opens Large-Scale Oligonucleotide Mfg. Facility
State-of-the-art facility expands capacity and capability for this novel modality, providing services from preclinical to commercial.01.03.20
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Breaking News | Drug Development | Trials & Filings
FDA Approves Allergan’s UBRELVY
Represents the first and only orally-administered CGRP receptor antagonist for the treatment of migraine01.02.20
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Breaking News | cGMP Manufacture | Chemistry | Industry News
OncoImmune’s IND Gains FDA Clearance
WuXi Biologics to provide CMC development and GMP manufacturing of the drug substance and drug product for next-gen anti-CTLA-4 antibody01.02.20
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Drug Development | R&D
Top Pharma M&A Deals of 2019
Drug manufacturers spent a record $342 billion on Mergers & AcquisitionsKristin Brooks, Contract Pharma 12.23.19
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Trials & Filings
XTANDI Approved for mCSPC
The first oral treatment in three distinct types of advanced prostate cancer –non-metastatic and metastatic castration-resistant prostate cancer (CRPC).Astellas 12.17.19
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Sanofi Awarded $226M by US Gov't for Pandemic Influenza Preparedness
U.S.-based, state-of-the-art facilities to be established for sustainable production of adjuvanted recombinant vaccine for use in the event of a pandemic.Sanofi 12.13.19
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Breaking News | CRO News | Promotions & Moves
Parexel Adds Experts to Regulatory Consulting Group
Four new hires from U.S. FDA and MHRA will serve as technical vice presidents12.10.19
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Breaking News | Formulation Development | Industry News
Catalent, Bridge Therapeutics Execute Exclusive License Agreement
To utilize Catalent’s Zydis orally disintegrating tablet (ODT) technology for opioid addiction therapeutic product12.10.19
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Breaking News | Drug Development | Trials & Filings
VistaGen Gains Fast Track for SAD Drug
PH94B neuroactive nasal spray for on-demand treatment of social anxiety disorder completes successful Phase II development12.10.19
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Biologics, Proteins, Vaccines | Breaking News | Industry News
Sanofi Pasteur Awarded HHS Pandemic Flu Vax Contract
To increase domestic pandemic influenza vaccine production capabilities in Swiftwater, PA12.09.19
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CRO News
Vivera Pharma, Parexel Ink Clinical Services Agreement
Parexel to conduct Phase I study to evaluate the bioavailability of TABMELT technology and provide regulatory support for Vivera's IND12.06.19
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Recipharm, RedHill Biopharma Ink Commercial Mfg. Pact
CDMO to provide commercial manufacturing to support Talicia launch following FDA approval.12.04.19
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Breaking News | Formulation Development | Industry News
Catalent, Ethicann Partner on Fast-Dissolve Treatment
Will leverage Catalent’s Zydis ODT technology to develop a new pharmaceutical-grade CBD and THC product to treat spasticity in MS patients12.03.19
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Breaking News | cGMP Manufacture | Drug Development | Industry News
Piramal, BerGenBio Partner on Leukemia Drug
Piramal to leverage its Xcelerate Integrated Solutions platform and is expected to provide commercial manufacturing of the final product12.03.19
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Breaking News | Collaborations & Alliances
Appili, Saptalis Enter Commercial Pact
Saptalis to oversee the regulatory review, manufacturing and preparation for the anticipated commercialization of ATI-1501 in the U.S.12.03.19
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Biologics, Proteins, Vaccines | Drug Development
Immunogenicity Assessment of Gene Therapy Compounds
Dr. Kromminga of BioAgilytix discusses testing challenges and evolving trends in gene therapy.Dr. Arno Kromminga, global chief scientific officer, BioAgilytix 11.27.19
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Breaking News | Collaborations & Alliances | Industry News | Supply Chain
Vizient and Fresenius Kabi Expand Partnership
Complete Novaplus contract enhancement for six critical care drugs.11.26.19
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Breaking News | Drug Development | Trials & Filings
SK Bio Gains FDA Approval for XCOPRI
Marks the first time a Korean company has independently brought a compound from discovery to U.S. FDA approval11.25.19
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Breaking News | Collaborations & Alliances | Drug Development | Trials & Filings
Roche’s Risdiplam for SMA Granted Priority Review
FDA filing triggers $15M milestone to development partner PTC Therapeutics11.25.19
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Cold Chain Management | Logistics | Serialization | Supply Chain
Review of FDA DSCSA Guidance Documents
Brian Daleiden of TraceLink reviews the latest requirements from the FDA and DSCSA
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Supply Chain
Effect of Personalized Medicine on the Pharma Supply Chain
As the FDA approves personalized drugs, the pharmaceutical supply chain must transform to meet the demand.Alexander Amelin, SVP, client success, SoftServe 11.22.19
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Assessing Current DSCSA Implementation
A detailed view of the industry’s progress with DSCSA Serialization Requirements.Peter Sturtevant, Senior Director Industry Development - Pharmaceuticals, GS1 US 11.22.19
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Breaking News | cGMP Manufacture | Industry News
Catalent, BeiGene Enter Long-Term Supply Agreement
Will manufacture BRUKINSA, a Bruton’s tyrosine kinase (BTK) inhibitor that recently received accelerated approval from the U.S. FDA.11.21.19
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Breaking News | cGMP Manufacture | Industry News
IsoTherapeutics Gains Approval to Manufacture Q BioMed Drug
ITG is now cleared to manufacture the company's FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP11.21.19
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Injectables
Pitfalls to Avoid When Packaging Injectable Drug Products
Addressing legacy systems, lack of innovation adoption, and special challenges of New Molecular Entities.Fran DeGrazio, VP, Scientific Affairs and Technical Services, West Pharmaceutical Services 11.20.19
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APIs
India to Track API Packs
India is mulling a shakeup in the regulations governing the distribution of pharmaceutical products.S. Harachand, Contributing Editor 11.20.19
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Solid Dosage/Creams/Ointments
The “Greening” of Solid Dosage Form Manufacturing
Going “green” can mean saving big bucks for pharma manufacturers.Emil W. Ciurczak, DoraMaxx Consulting 11.20.19
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When Life Gives You Lemons…Raise Your Drug Prices
The hidden effect of economic models on global drug supply and shortages.Ben Locwin 11.20.19
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A Pharmaceutical Smörgåsbord
This last issue of the year covers a wide range of pharma topics.Tim Wright, Editor 11.20.19
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Supply Chain
Clinical Trial Technology
The use of new technology to monitor and manage clinical trialsRicky Lakhani, Director of Product Management, PHARMASEAL 11.20.19
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Biologics, Proteins, Vaccines
Regenerative Medicine: Overcoming the supply chain challenges
Accomplishing the goal of widespread use of regenerative medicine doesn’t come without its challenges.Rich Quelch, Global Head of Marketing, Origin 11.20.19
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Excipients
Towards Sunset or a New Dawn?
China as the world production hub of fine and specialty chemicals.Dr. Michele Jermini and Dr. Enrico Polastro 11.20.19
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Biologics, Proteins, Vaccines | Biosimilars
Biopharma Over 20 Years
A look at the key trends that have impacted the biopharma industry over the years.K. John Morrow, Jr. and Eric S. Langer, BioPlan Associates 11.20.19
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Biologics, Proteins, Vaccines | Breaking News | Industry News | Toxicology
WuXi AppTec’s Lab Testing Division Expands in Suzhou
Increases toxicology capacity by 80% to execute full-service preclinical and clinical safety assessments for biologics and small molecules11.19.19
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Breaking News | Clinical Trials | CRO News | Drug Development | Industry News | Information Technology
Frontage Implements ClinSpark eSource Platform
Web-based eSource platform supports activities from subject recruitment through database lock11.19.19
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Biologics, Proteins, Vaccines | Clinical Trials
Advanced Therapies: Adding a New Layer of Complexity to Clinical Trials
Overcoming the challenges of a new and changing clinical trial landscapeErin Finot, Global Head of Immuno-Oncology, IQVIA Biotech 11.18.19
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Breaking News | Facilities | Industry News | Inspections
Metrics Completes Japanese Regulatory Inspection
Marks the first international inspection of the company’s new 126,000-square-foot commercial manufacturing facility constructed in 2018.11.18.19
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Drug Development | Industry News
Roche to Acquire Promedior in $1.4B Transaction
Gains full rights to Promedior's entire portfolio of molecules for serious fibrotic diseases11.15.19
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CDMOs to Benefit From Rising BTDs, Orphan Drugs and Fast Track Status
The arrival of patient-centric CDMO’s predicted by CPhI Annual Report.11.14.19
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Breaking News | Collaborations & Alliances | Drug Delivery | Industry News | Packaging & Tracking
Stevanato, Duoject Enter Auto-injector Collaboration
Partnership to promote and manufacture the emergency-use ‘Maverick’ auto-injector.11.13.19
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Biologics, Proteins, Vaccines
Cell and Gene Therapy Landscape
Heather Myler of PPD provides current insight into the growing field of Cell and Gene Therapies11.12.19
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Drug Development | Industry News
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Analytical Services | Bioanalytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Formulation Development
Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma
David Enloe of Ajinomoto Bio-Pharma Services shares his perspective on market changes over the years and the evolution of more integrated outsourcingKristin Brooks, Contract Pharma 11.11.19
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
PharmaCyte Biotech Closer to Submitting IND
Austrianova completes encapsulation of second manufacturing run of clinical trial product.11.11.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
IDT Biologika, NIH Mfg. Contract Updated
Awarded new task order in the scope of 10-year NIH contract to manufacture vaccines and biologics for infectious diseases.11.11.19
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Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
Bryn Partners With Aptar for Nasal Spray Device
Bryn’s Epinephrine Nasal Spray has two doses in one portable device.11.01.19
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Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments
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Breaking News | Industry News | Regulatory Affairs | Solid Dosage/Creams/Ointments
Absorption Systems Awarded Contract by FDA
To conduct in vitro testing of the effects of excipients on oral drug absorption.11.01.19
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cGMP Manufacture | Drug Development
Contract Pharma’s 20th Anniversary Series: CDMO Insight
JoyL Silva of Pfizer CentreOne discusses global market and regulatory changes driving drug development strategies and the evolution of CDMO services and ops.Kristin Brooks, Contract Pharma 11.01.19
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Breaking News | Industry News | Regulatory Affairs
FDA Leaders Address Drug Shortages
Acting Commish Ned Sharpless and CDER director Janet Woodcock release statement on FDA's new report about root causes and solutions to drug shortages.10.30.19
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CPhI Annual Report 2019: Part 1
FDA should withdraw ANDAs, and new technologies could bring massive improvements in efficiency if implemented correctly.10.29.19
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The Role of Technology Within Regulatory Compliance in Bioanalysis
Learn how current technology is playing a role in the regulatory process at PharmSci 36010.29.19
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Clinical Trial Materials | Clinical Trials | Information Technology
Contract Pharma’s 20th Anniversary Series: Clinical Supply
Technology plays a big role in clinical trials, supplies, and the rise of patient-centricityKristin Brooks, Contract Pharma 10.29.19
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Clinical Trials | CRO News | Drug Development | Information Technology | R&D
Contract Pharma’s 20th Anniversary Series: CRO Perspective
Randy Marchbanks of PPD discusses how CRO operations have evolved to accommodate changing industry needsKristin Brooks, Contract Pharma 10.28.19
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Breaking News | Capsules | Facilities | Industry News
CDMO to Invest Over €3M in GMP Facility Expansion
Micro-Sphere will add an additional spray drying line to its facility in Switzerland.10.28.19
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Breaking News | Facilities | Industry News | Inspections
WuXi STA’s Jinshan Facility Passes EMA Inspection
Five-day inspection covered 11 products approved by EMA in recent years.10.28.19
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Chemic Laboratories, Inc.
Chemic Laboratories, Inc. is a cGMP/GLP, FDA registered and DEA licensed contract analytical testing facility.10.25.19
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Clinical Trials | Information Technology
Clinical Trial Technology
The use of new technology to monitor and manage clinical trials.Ricky Lakhani, Director of Product Management, PHARMASEAL 10.25.19
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Pharma Packaging Solutions
PPS is a turn-key contract packager offering bottling, blister packaging, folding carton production, kitting, as well as vial/ampule and parenteral labeling.10.24.19
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R-Pharm Germany GmbH
R-Pharm Germany GmbH is a reliable CDMO, covering a wide range of manufacturing and packaging solutions for solid dosages.10.24.19
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Breaking News | Packaging & Tracking | Serialization | Supply Chain
Barcode Assessment Study Reveals Progress Addressing DSCSA Requirements
GS1 US Barcode Assessment Shows 74% of scanned barcodes meet serialization requirements.10.24.19
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Breaking News | Packaging & Tracking | Solid Dosage/Semi-solids
Aptar’s Activ-Blister Packaging Solution Approved for HIV Drug
System protects oral solid drug products with a 3-Phase Activ-Polymer solution, including moisture adsorption, oxygen and odor scavenging.10.24.19
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Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments
Foamix Enters Contract Manufacturing Agreement
Signs manufacturing and supply deal with ASM for AMZEEQ and FMX103.10.23.19
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Breaking News | Collaborations & Alliances | Drug Delivery | Industry News
Phillips-Medisize Inks Combination Drug Deal
Wins contract to manufacture first electronic-enabled combination drug delivery product.10.23.19
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How Can a Contract Development and Manufacturing Organization Advance a Cell & Gene Therapy Product?
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
FPP Inks ANDA Generic Deal
Upon approval, manufacturing will be performed by the CDMO Novocol.10.21.19
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Clinical Trials | Drug Development | Information Technology
Better Collaboration is Key to Speeding Trials
Clinical leaders discuss bringing together disparate processes and systems for improved collaboration and more efficient trial execution at Veeva R&D SummitJim Reilly, vice president of clinical strategy at Veeva Systems 10.18.19
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Breaking News | Drug Discovery | Industry News | Preclinical Outsourcing
BioIVT Acquires PPA Research Group
Expands product portfolio to support immuno-oncology and cell therapy research10.18.19
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Mesoblast and Lonza Enter Manufacturing Agreement
For commercial manufacture of Mesoblast’s potential first US allogeneic therapy10.17.19
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Clinical Trials | Drug Development
Contract Pharma’s 20th Anniversary Retrospective: Drug Development
A look back at the role of CROs in drug development and what we can expect for the futureKristin Brooks, Contract Pharma 10.16.19
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Information Technology
Data Management in Life Sciences: Then and Now
A look at landmark changes in the management of data in the life sciences over the last 20 years and how the industry has addressed the challenges these developJason Lacombe, CEO, Veratrak 10.15.19
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Analytical Services | Drug Development
The Importance of Using an Accurate Pharmaceutical Composition Analyzer
With one quick, nondestructive test, an accurate composition analyzer can provide the simultaneous analysis of the entire composition of the sampleJeff Elliott, Contributing Writer 10.15.19
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Like It’s 1999
Reflecting on 20 years of Contract Pharma.Gil Roth, President, Pharma & Biopharma Outsourcing Association 10.15.19
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Supply Chain
Supply Chain Disruptions
The implications of Sandoz’ recent recalls.Ed Silverman, Guest Columnist 10.15.19
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A Witness to the Growth of Outsourcing
Observations from the 2019 Contract Pharma Conference.Emil W. Ciurczak, DoraMaxx Consulting 10.15.19
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Regulatory Affairs
Inactive Ingredients: Where Guidance Needs to Meet Data
Looking at FDA’s most recent draft guidance and the struggle with inactive ingredients.Sharif Ahmed, Lachman Consultants Services 10.15.19
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Escaping the Niche Career Box
Broaden your horizons to unlock your true growth potential.Ryan Raver, PhD, Contributing Editor 10.15.19
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Clinical Trial Materials
Overcoming the Small Molecule Bioavailability Challenge
Approximately 90% of preclinical compounds are estimated to face bioavailability challenges.David Lyon, Sr. Research Fellow, Lonza Pharma & Biotech 10.15.19
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cGMP Manufacture
Deriving Value from Integrated cGMP and Pre-GMP Manufacturing Operations
The benefits of leveraging a mix of GMP and pre-GMP facilities.Didier Combis, Commercial Director, Seqens CDMO 10.15.19
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APIs | Cytotoxics and High Potency Manufacturing | Facilities
Flamma Arrives in the U.S.
Italian CDMO sets down roots in the U.S. market with purchase of Teva facility.Tim Wright, Editor, Contract Pharma 10.15.19
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Contract Pharma’s 20th Anniversary Retrospective
A look back a the pharma/biopharma industry and the future of outsourcing.Kristin Brooks, Managing Editor, Contract Pharma 10.15.19
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Clinical Trials | CRO News | Drug Development
NSF International Acquires Interest in Amarex CRO
Amarex will gain access to NSF’s network and international scale and will continue to operate from its U.S. office10.09.19
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Drug Delivery | Industry News
Stevanato Group, Haselmeier Ink Exclusive Agreement in Diabetes Care
Licenses Axis-D Pen-injector technology and IP to support diabetes applications10.07.19
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Breaking News | Industry News | Regulatory Affairs
LSNE's Spain Site Gets FDA Approval
LSNE-León is the fourth facility to gain commercial approval10.04.19
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cGMP Manufacture
Designing a Successful Oligonucleotide Facility
Five questions you probably aren’t asking, but shouldChelsea Stramel, Architectural Designer and Jake Adams, Process Engineer , CRB 10.04.19
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Q BioMed, Jubilant Radiopharma Enter Commercial Pact
Once approved, Q BioMed to serve as contract manufacturer of non-opioid cancer palliation drug, Strontium-89 Chloride Injection, in the U.S.10.03.19
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Breaking News | Collaborations & Alliances | Industry News
Mayne, Mithra Sign 20-Year License and Supply Agreement in the US
For Mayne’s novel oral contraceptive E4/DRSP; launch is expected in 1H of 202110.02.19
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Cellectis and Lonza Enter cGMP Manufacturing Service Agreement
Agreement covers manufacturing of clinical supply for Cellectis’ UCART pipeline10.02.19
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Biopharmaceuticals & Analytical Testing Technology
Analytical technology and processes are evolving as the biologics industry continues to grow.10.01.19
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Clinical Trials | Industry News | Information Technology
Elligo Receives FDA Grant to Study Real-World Data
Follow-on project aims to extend the value of data harmonization in the generation of clinical evidence from real-world data to support regulatory use10.01.19
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Breaking News | Industry News | Inspections | Regulatory Affairs
Almac Completes Three Regulatory Inspections
Inspections at Charnwood, Craigavon, and Audubon sites successful09.27.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
Continued and Consistent Investment in Manufacturing Facilities
As companies move their cell and gene therapies through the development process, supporting larger Phase III trials and commercial launches will be a challengeRyan Carpentier, Executive Director of Business Development, Cryoport 09.23.19
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Breaking News | Clinical Trials | Industry News | Solid Dosage/Creams/Ointments
Hovione Reports Successful End-of-Phase 2 Meeting With the FDA
Outlines Phase 3 program for Minocycline Topical Gel09.23.19
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Injectables
Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product
ANDA holder Sagent will sell, market and distribute the drug product in the U.S.09.23.19
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cGMP Manufacture | Clinical Trial Materials | Industry News
iBio, AzarGen Biotechnologies Expand Mfg. Pact
Advances development of a plant-made rituximab for AzarGen using FastPharming System09.19.19
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Clinical Trials | CRO News | Drug Development
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Bio News | Breaking News | Industry News | Inspections
3P Biopharmaceuticals Receives FDA approval
FDA classified 3P facilities as acceptable for manufacture of target molecule, and appropriate for commercialization in the US once product is authorized09.18.19
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Breaking News | Collaborations & Alliances | Industry News | Parenterals
Civica Rx and Exela Pharma Sciences Join Forces to Supply Sodium Bicarbonate
Partnership will help stabilize supply of a vital medicine used daily for emergency care in hospitals across the US09.18.19
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Breaking News | Collaborations & Alliances | Industry News | Packaging & Tracking | Serialization
Vantage Solutions Supports FDA Pilot for Verification Router Service
Will provide independent oversight of test execution and aggregation of the results09.18.19
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Chemistry | Industry News | Laboratory Testing
CMC Pharmaceuticals Launches cGMP Lab Services
Addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines09.17.19
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Cytotoxics and High Potency Manufacturing
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Biosimilars
The Bioprocessing Trek
Biosimilars are the next speed-bump for CMOsEmil W. Ciurczak, DoraMaxx Consulting 09.16.19
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Regulatory Affairs
Quality Metrics Feedback
A look at FDA’s Quality Metrics Initiative, a complicated issue for all of pharma stakeholdersGil Roth, President, Pharma & Biopharma Outsourcing Association 09.16.19
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Regulatory Affairs
Continuous Manufacturing and its Regulatory Challenge
...José L. Toro, PhD, Lachman Consultants 09.16.19
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It’s Showtime!
Come to New Brunswick, NJ and fulfill all your outsourcing desires!Tim Wright, Editor 09.16.19
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Drug Development | Regulatory Affairs
Guidelines in Toxicology: A Blessing and a Curse
A look at the evolution of drug development regulatory guides.Sarah Gould, Senior Principal Scientific Advisor, Charles River 09.16.19
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Drug Discovery
Drug Discovery Technology Trends
Combining native mass spectrometry with fragment-based drug discovery in medicinal chemistrySally-Ann Poulsen, Professor of Chemical Biology, Griffith Institute for Drug Discovery (GRIDD), Griffith University 09.16.19
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Clinical Trials
Gene Therapy Trials
Applications and the limitations of real-world data.Karen Ooms, Executive Vice President and Head of Statistics, Quanticate 09.16.19
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Cytotoxics and High Potency Manufacturing
High Containment & Cost Savings with Single Use Isolator Technology
The trend towards HPAPIs is driving the need for innovative containment systems.Scott Patterson, Vice President Commercial Sales, ILC Dover 09.16.19
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APIs | Regulatory Affairs | Supply Chain
API Supply Chain Strategy
How to risk-proof your API supply chain for a successful 505(b)(2) filing.Shailesh Vengurlekar and Hamilton J. Lenox, LGM Pharma 09.16.19
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Biologics, Proteins, Vaccines | Drug Delivery | Drug Development
Knowledge Sharing: Biologics Development and Delivery
The increasing importance of sharing information to build awareness and better manage the complexities of drug development.Fran L. DeGrazio, Vice President of Scientific Affairs and Technical Services, West Pharmaceutical Services 09.16.19
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Breaking News | Clinical Trials | Industry News | Inspections | QA/QC
FDA Extends CRADA with CluePoints
Aims to further explore a data-driven approach to quality oversight in clinical trials09.11.19
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Biologics, Proteins, Vaccines | Cold Chain Management | Drug Development | Supply Chain
CAR T for Large Tumors: The Next Frontier?
Ryan Carpentier of Cryoport discusses the successes and the challenges these exciting new therapies presentRyan Carpentier, Executive Director of Business Development at Cryoport 09.10.19
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Promotions & Moves
Altimmune Appoints M. Scott Harris as CMO
Dr. Harris brings extensive drug development experience having led numerous global clinical studies09.09.19
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Breaking News | Drug Development | Trials & Filings
FDA Approves Boehringer’s Ofev
Becomes the first and only therapy to slow the rate of decline in pulmonary function in systemic sclerosis-associated ILD09.09.19
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Breaking News | Drug Development | Industry News
Thermo, Lilly Enter Companion Diagnostic Pact
Thermo retains rights to commercialize the test in all markets and will submit a supplemental premarket approval to FDA09.09.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Emergent Awarded 10-Year HHS Contract
To deliver ACAM2000 smallpox vaccine into the national stockpile09.06.19
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Fill/Finish | Injectables
Four Pitfalls to Avoid When Packaging Injectable Drug Products
Addressing legacy systems, lack of innovation adoption, and special challenges of New Molecular EntitiesFran DeGrazio, Vice President of Scientific Affairs and Technical Services, West Pharmaceutical Services, Inc. 09.04.19
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Breaking News | Industry News | Inspections
Bora Secures FDA Approval for CDMO Services
Reports successful inspection of Zhunan, Taiwan site09.03.19
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Bio News | Biosimilars | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Lonza, Celltrion Sign Contract to Manufacture Remsima Drug Substance
Lonza’s biologics facility in Singapore to cover EU and U.S. market needs09.03.19
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Industry News
Freudenberg Medical Announces Compendium of Test Results for PharmaFocus
Compendium tests provide companies with the results they need to use PharmaFocus Premium in their processing08.30.19
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Trials & Filings
Eton Receives NDA Acceptance for Oral Liquid Seizure Medication
ET-105 addresses unmet needs of patients with dysphagia and pediatric patients requiring doses lower than available tablet strengths08.29.19
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Orchestra BioMed Appoints Chief Medical Officer
Dr. Donohoe brings nearly 30 years of clinical and regulatory experience08.27.19
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Mustang Bio, CSL Behring Enter License Agreement for Stable Producer Cell Line
Cytegrity™ is a stable producer cell line developed by St. Jude Children’s Research Hospital for the treatment of X-linked severe combined immunodeficiency08.27.19
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Lilly Receives FDA Approval for Ankylosing Spondylitis Treatment
This is the third indication for Taltz, first approved for moderate to severe plaque psoriasis08.27.19
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Clinical Trials | Information Technology | R&D
Leveraging Machine Learning and AI in Clinical Research
New streams of real-world data from electronic health records and other data sources, with advances in ML, will be crucial for creating next-gen clinical trialsJennifer Bradford, Ph.D., Head of Data Science at PHASTAR 08.19.19
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cGMP Manufacture | Clinical Trial Materials | Industry News | Process Development | R&D
IBBR Seeks RFPs for cGMP Biologics Manufacturing
Facility is also equipped to perform process development research, preclinical manufacturing for IND-enabling tox studies, Point of Concept studies08.19.19
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Trials & Filings
FDA Approves AbbVie's New RA Drug
Approximately 30 percent of patients treated with RINVOQ achieved clinical remission at week 12 and week 1408.19.19
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Drug Development | Trials & Filings
Roche Wins Two Approvals for Cancer Drug Rozlytrek
Becomes third tumor-agnostic drug to win FDA Approval08.16.19
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Clinical Trials | Drug Development | Information Technology
Embracing Risk-Based Monitoring: The Pivotal Role of Tools and Technologies
Opportunities to improve the implementation of risk-based monitoring (RBM) in clinical investigationsJonathan Andrus, Chief Business Officer, Clinical Ink 08.15.19
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Trials & Filings
FDA Approves New Treatment for Drug-Resistant TB
Pretomanid is only the third new anti-TB drug approved by FDA in more than 40 years08.15.19
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Industry News | R&D
Syapse, FDA Announce RCA Using Real-World Evidence
Focus on advancing real-world oncology endpoints and providing insight into evidence-based clinical decision-making08.15.19
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Analytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
Boston Analytical Continues Expansion
Opens office in Cambridge spurred by double-digit growth08.15.19
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APIs | Breaking News | Collaborations & Alliances | Industry News
CDMO Indena Improves Manufacturing Process
Jaguar Health's manufacturing partner to support expanded crofelemer manufacturing volume08.14.19
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Bio News | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News
Caladrius, Cognate Ink Clinical Manufacturing Agreement
For phase 3 trial of CLBS14 in no-option refractory disabling angina08.12.19
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Reed-Lane Opens Cold Chain Room for Vial and Ampoule Kitting
New facet to Contract Packager’s growing Cold Storage capabilities helps expand service offerings into biopharma sector
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
Eurofins Genomics US Expands Gene Synthesis Capabilities
Acquires Blue Heron Biotech, known for expertise in gene synthesis and sub cloning08.09.19
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Collaborations & Alliances | Drug Development
Agenus, Gilead Milestone Triggers $7.5M Payment
FDA acceptance of IND filing for AGEN237 represents the second milestone in Gilead partnership achieved in 201908.08.19
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Bioanalytical Services | Industry News
Sartorius Launches New Services for Mammalian Cell Bank Manufacture
Combines services for cell line development, cell bank manufacturing, and cell bank characterization08.08.19
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Bio News | Breaking News | Industry News | Promotions & Moves | QA/QC | Regulatory Affairs
Goodwin Biotechnology Bolsters Quality & Regulatory Capabilities
Names Gerald Orehostky as vice president of quality and regulatory operations08.07.19
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APIs | Breaking News | Facilities | Industry News | Inspections
Carbogen Amcis API Site Passes FDA PAI
Completes successful FDA inspection of its Neuland site in Hunzenschwil, Switzerland with no Form 483s08.07.19
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Breaking News | Facilities | Industry News
Vetio Completes Plant Expansion in Montreal
Facility produces liquids, semi-solids, tablets, intermediates and blends08.02.19
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cGMP Manufacture | Collaborations & Alliances
NIIMBL, FDA to Advance Innovation in Bio Manufacturing
CRADA enables FDA and NIIMBL to support investments in regulatory science research, and training needed to foster advanced manufacturing innovations08.01.19
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Trials & Filings
Nektar Therapeutics, BMS Receive Breakthrough Therapy Designation
Bempegaldesleukin in combination with Bristol-Myers Squibb's Opdivo aims to treat patients with untreated advanced melanoma08.01.19
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Bio News | Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Omeros, Lonza Enter Commercial Manufacturing Agreement
Builds on existing clinical supply deal for narsoplimab07.31.19
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Trials & Filings
Mustang Bio’s AML Treatment Receives Orphan Drug Designation
MB-102 (CD123 CAR T) evaluated to treat AML and BPDCN07.30.19
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Merck to Build $650M Biomanufacturing Plant in NC
New 225,000 square foot facility to produce active ingredient for the Gardasil 9 vaccine07.29.19
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Bio News | Biosimilars | Breaking News | Collaborations & Alliances | Industry News
Alvotech, Cipla Gulf Ink Biosimilar Deal
Will partner for the commercialization of key biosimilar in select emerging markets07.29.19
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cGMP Manufacture | Industry News | Regulatory Affairs
FDA Posts FY2020 GDUFA Fees
The fee for U.S. CMO FDF facilities will drop 7% next year; negotiation efforts led by PBOA07.25.19
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Industry News | Inspections | Regulatory Affairs
WuXi STA Facilities Pass U.S. FDA Inspections
Analytical Service Unit in Shanghai and API manufacturing facility in Changzhou successfully pass inspections07.24.19
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Trials & Filings
La Jolla Pharma Receives Orphan Designation for Malaria Treatment
LJPC-0118, artesunate, demonstrated to be superior to quinine in reducing mortality in patients with falciparum malaria infection07.23.19
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Bio News | Breaking News | Facilities | Industry News | Validation
Yisheng Receives GMP Certification in China
Invested about $60 million to build two new vaccine production facilities07.23.19
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Breaking News | Collaborations & Alliances | Industry News | Injectables
Hikma, Civica Rx Ink Generic Drug Shortage Deal
Partnership will supply 14 essential medicines to U.S. hospitals and patients07.23.19
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Breaking News | Industry News | Inspections
WuXi STA Facilities Pass FDA Inspections
No Form 483s were issued at Shanghai and Changzhou sites07.23.19
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Bio News | Biologics, Proteins, Vaccines | Biosimilars | Breaking News | Collaborations & Alliances | Facilities | Industry News
Celltrion, Nan Fung Group Set Up Bio CDMO in China
Establish Vcell Healthcare to develop and commercialize biosimilars; will open biologics manufacturing facility07.19.19
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Pricing Headwinds
Generic firms see red; CDMOs stay resilientS Harachand, Contributing Editor 07.17.19
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cGMP Manufacture | Industry News | Scale-up/Technology Transfer
Mapi to Establish New Sterile Production Plant for GA Depot
Mapi will supply GA Depot to Mylan for commercial sale07.16.19
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cGMP Manufacture | Industry News
Catalent, AveXis Enter Long-term Strategic Mfg. Pact
AveXis will have dedicated manufacturing space at Paragon’s new commercial manufacturing center near Baltimore-Washington Int’l Airport07.16.19
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Trials & Filings
FDA Accepts RedHill Biopharma’s NDA for Talicia
Commercial launch of H. pylori treatment is planned shortly following potential FDA approval07.16.19
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Financial Reports
Intra-Cellular Therapies Announces Positive Phase III Results
Lumateperone achieves topline results in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder07.16.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | GMPs/GCPs | Regulatory Affairs
Knowledge Sharing in the Development and Delivery of Biologics
The increasing importance of sharing information to build awareness and better manage the complexities of drug developmentFran L. DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services, Inc. 07.15.19
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Biologics, Proteins, Vaccines
Outsourcing in China: How far can it go?
China’s biopharmaceutical services market is on pace to top $1 billion by 2021Vicky Qing Xia, BioPlan Associates 07.15.19
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Analytical Services | Laboratory Testing
Re-Open Your Tool Chest
There’s no longer an excuse NOT to start “PAT-ing” your productsEmil W. Ciurczak, DoraMaxx Consulting 07.15.19
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QA/QC | Validation
Considerations for Analytical Method Validation Lifecycle Controls
ICH is set to implement new regulatory guidance dedicated to analytical method developmentPaul Mason, PhD, Lachman Consultants 07.15.19
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Biologics, Proteins, Vaccines | Industry News | Supply Chain
Werum IT Solutions Partners with Blood Centers of America
Strategic partnership to develop a “vein-to-vein” digital supply chain solution suite07.11.19
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Trials & Filings
Syndax Pharma Gets IND Clearance for Leukemia Treatment
Will begin Phase 1/2 trial for targeted Menin inhibitor, SNDX-5613, in patients with relapsed/refractory acute leukemias07.11.19
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Extractables and Leachables | Laboratory Testing
The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standardsKristin Brooks, Contract Pharma 07.11.19
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Trials & Filings
Cellectar Receives FTD for Diffuse Large B-Cell Lymphoma Treatment
Drug conjugate, CL131, delivers cytotoxic radiation directly and selectively to cancer cells07.09.19
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Trials & Filings
SunGen Pharma Receives Sixth ANDA Approval from FDA
Methylprednisolone approved for treatment of arthritis, allergic reactions, and immune system disorders07.09.19
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cGMP Manufacture | Clinical Trial Materials | Facilities | Industry News
GSK Opens Two Mfg. Facilities in Singapore
Invests $95 million for continuous manufacturing to shorten timelines to produce daprodustat07.09.19
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Collaborations & Alliances | Industry News
Y-mAbs Secures Commercial Radiolabeling Capacity
Enters agreement with SpectronRx to produce metastatic central nervous system neuroblastoma treatment, omburtamab07.03.19
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APIs | Breaking News | Facilities | Industry News
FLAMMA Acquires Teva’s Philadelphia cGMP Facility
Marks entry into the U.S. marketplace with labs & pilot plant07.01.19
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Drug Development | Trials & Filings
FDA Approves J&J's DARZALEX in Multiple Myeloma
Results showed that DARZALEX significantly reduced the risk of disease progression or death by 44 percent06.28.19
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ContraVir Pharmaceuticals Submits IND for NASH Drug
IND positions NASH as a second indication for CRV431, in addition to HBV06.27.19
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Clinical Trials | GMPs/GCPs | QA/QC | Regulatory Affairs
Good Clinical Practice: Serious Breach Process
How to assess the significance of the breach, who needs to be involved, and how to report itJane Wood, Principal, YourEncore Quality Center of Excellence 06.27.19
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Industry News
Akorn Receives Warning Letter from FDA
Relates to the inspection of its Somerset, NJ manufacturing facility in July and August of 201806.26.19
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Bio News | Breaking News | Collaborations & Alliances | Industry News
Axovant, Yposkesi Sign Gene Therapy Deal
CDMO to support the global development and commercialization of Axovant’s gene therapy programs06.20.19
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Trials & Filings
Sierra’s Momelotinib Granted FDA Fast Track Designation
Underscores potential for momelotinib to address unmet needs of patients with Intermediate/High-Risk myelofibrosis who have previously received a JAK inhibitor06.19.19
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Trials & Filings
SELLAS Achieves Immune Response Data in Triple Negative Breast Cancer
NPS-Specific Cytotoxic T-Lymphocyte mean frequencies increased by 2.86-fold compared to Baseline at 30 months06.19.19
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cGMP Manufacture | Industry News
Gamida Cell and Lonza to Manufacture Omidubicel
Strategic manufacturing agreement is signed for the future commercial production of Phase 3 investigational advanced cell therapy06.19.19
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Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
Cytovance Completes Second FDA PAI of Oklahoma Facilities
Demonstrates capabilities and cGMP compliance in manufacturing commercial products06.18.19
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Promotions & Moves
Avomeen Appoints Head of Elemental Analysis
Mr. Ferencz will help clients comply with regulations such as USP 232 and USP 233, as well as California Proposition 6506.17.19
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cGMP Manufacture | Industry News
LSNE Buys Sterile Injectables Mfg. Facility in León, Spain
Expands full-service manufacturing capabilities into Europe06.17.19
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Risk-Based Monitoring
Leveraging intelligent analytics to realize the full value of RBx and compliance with ICH E6 (R2)Richard Davies, Vice President, Solution Expert, CluePoints 06.13.19
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