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APIs | Supply Chain
Maintaining Critical Drug Supply During the Pandemic
Vin Colicchio from Dr. Reddy’s talks about the challenges and solutions of maintaining supply during the pandemic.Online Exclusives Tim Wright, Editor, Contract Pharma 06.17.21
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Breaking News | Collaborations & Alliances | Industry News
KBI Biopharma, AM-Pharma Enter Manufacturing Agreement
Partnership supports future commercial manufacturing for AM-Pharma’s potential kidney disease treatment.06.17.21
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Breaking News | Facilities | Industry News | Lyophilization
Horizon Therapeutics Buys EirGen Manufacturing Facility
The 44,000 square foot facility in Ireland includes fill-finish and analytical laboratory capabilities with potential for site expansion.06.17.21
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Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News
Sanofi Invests $425M in Flu Vaccine Manufacturing Facility
Newly licensed U.S. manufacturing facility to increase availability of Fluzone High-Dose Quadrivalent.06.17.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Discovery | Industry News
AbSci Acquires Cell Therapy Company Totient
Combination of Totient technology with AbSci's platform provides framework and data to enable in silico targeted drug design.06.17.21
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Clinical Trial Materials | Cold Chain Management | Logistics | Supply Chain
Mitigating the Logistical Challenges Associated with Clinical Studies of Investigational Drugs
How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.Contract Pharma Staff
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Breaking News | Facilities
Thermo Scientific Upgrades Ultra-Low Temperature Freezers
The TSX Series ULT Freezers reliably preserve stored materials in an environmentally and user-friendly design.06.16.21
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Breaking News | Collaborations & Alliances | Drug Development | Formulation Development
Lumen Bioscience, Novo Nordisk Enter Metabolic Research Pact
To explore Lumen's drug development and manufacturing platform to deliver oral biologics for cardiometabolic disease.06.16.21
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Breaking News | Promotions & Moves | Solid Dosage/Creams/Ointments
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Breaking News | Trials & Filings
REGEN-COV Phase 3 Trial Meets Primary Outcome
Improves survival by 20% in hospitalized COVID-19 patients lacking an immune response to SARS-CoV-2.06.16.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
Dendreon Pharmaceuticals Establishes Contract Manufacturing Division
Now offers end-to-end manufacturing of complex cell therapies and patient logistics for partner programs.06.15.21
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Tablet Development Process Training - July 20-21
This course provides comprehensive insight into the tablet development process to provide powerful tools that you can put to work immediately.
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Hunt for N-Nitrosamines in Medicinal Products
Case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.06.15.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Parenterals
Ocugen, Jubilant Enter COVID-19 Vaccine Partnership
Jubilant HollisterStier to manufacture COVAXIN for the U.S. and Canadian markets.06.15.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
VERAXA and Quadira Enter ADC Development Partnership
To develop a suite of novel ADCs for the treatment of oncological conditions.06.15.21
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Breaking News | Facilities | Industry News
TriRx Pharmaceuticals Buys Elanco Sites
The CDMO is to purchase sites in Shawnee, KS and Speke, UK including planned transfer of 600 employees.06.15.21
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Breaking News | Industry News | Solid Dosage/Creams/Ointments
Mikart Expands Oral Solids Production Capabilities
Acquires Korsch XM12 to meet client demands for complex formulation development and production of oral solid dose products.06.15.21
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Breaking News | Industry News
GENinCode, EVERSANA Enter Major U.S. Commercialization Pact
EVERSANA will support launch and commercialization in the U.S. market for GENinCode’s portfolio of polygenic cardiovascular disease products.06.14.21
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Capsules | Formulation Development
Formulation of Aqueous Core Poly(lactic acid) Microcapsules
This white paper demonstrates how single-step encapsulation of a water core can be achieved using Adare Pharma Solutions' Stratμm technology.
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
Yposkesi to Build Second Commercial Bioproduction Site
Creates a new global resource for cell & gene therapy with production capacity for early clinical to commercially available biologics.06.14.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development | Trials & Filings
Novavax COVID-19 Vax is 90% Effective in Phase 3 Trial
NVX-CoV2373 demonstrates 100% protection against moderate and severe disease, 90% efficacy overall, and met the primary endpoint.06.14.21
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Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development
iTeos Therapeutics, GSK Enter Monoclonal Antibody Alliance
GSK now has a leading portfolio of antibodies targeting the CD226 axis, a key target for next-gen immuno-oncology therapies06.14.21
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Biologics, Proteins, Vaccines | Breaking News | Industry News | Injectables
BD Hits 2 Billion Injection Device Milestone for COVID-19 Vaccinations
Company now supplying more than 40 countries for pandemic vaccination campaigns.06.11.21
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Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Drug Delivery | Industry News | Solid Dosage/Creams/Ointments
Enteris BioPharma Receives $10M Milestone from Cara Therapeutics
Third milestone payment related to the development of Oral KORSUVA.06.11.21
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Bio News | Breaking News | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News
Revolo and Northway Biotech Enter Manufacturing Partnership
To manufacture novel binding immunoglobulin protein, ‘1805, to support phase 2 trials in rheumatoid arthritis and uveitis.06.11.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Drug Development | Industry News
WuXi XDC and LegoChem Ink ADC Agreement
Sign MOU for the development and manufacturing of antibody-drug conjugates.06.11.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
Vibalogics Expands Manufacturing Capacity
Invests an additional $50 million to further expand cGMP manufacturing capacity for viral vectors.06.11.21
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Breaking News | Cold Chain Management | Industry News | Logistics | Supply Chain
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Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News
ProCell for Patient Project to Develop Automated Production Unit for CAR-T Cell Therapies
Standardized and automated manufacturing aims to reduce the amount of work on producing CAR-T cells by 50 percent.06.10.21
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Biologics, Proteins, Vaccines | Industry News
Pfizer, BioNTech to Provide 500M COVID Vax Doses to U.S. for Donation
Doses to be donated to approximately 100 low- and lower middle-income countries.06.10.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates
Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.
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Analytical Services | Bioanalytical Services | Breaking News | Facilities | Industry News | Laboratory Testing
CatSci Opens New Dagenham Laboratory
New facility is equipped with state-of-the-art analytical equipment through a collaboration with Shimadzu Corporation.06.09.21
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Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News | Logistics | Packaging & Tracking | Supply Chain
Yourway Breaks Ground on Major Expansion at Pennsylvania HQ
The project includes a new Phase I clinical trials unit.06.09.21
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Breaking News | Industry News | Promotions & Moves
Symbiosis Names Jette Cowan Biz Development Manager
Will build relationships with new and existing clients across the Nordic region and Germany.06.09.21
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Bioprocessing Technologies: Stainless Steel vs Single Use
Join us on June 22 for a brief introduction of the current competing market between stainless steel and single use systems.06.09.21
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Inspections | Validation
From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies
An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas.06.09.21
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Clinical Trials | CRO News | Industry News | Information Technology
Bioclinica Adds eConsent to EDC Platform
New electronic module is built to support the entire consent process from document approval by IRBs to in-person or remote interactions.Kristin Brooks 06.08.21
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Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Industry News
INOVIO, Advaccine Expand COVID Vax Alliance
To jointly conduct a global Phase 3 segment of the ongoing Phase 2/3 INNOVATE trial evaluating INO-4800 in a two-dose regimen.Kristin Brooks 06.08.21
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Breaking News | Drug Development
FDA Approves Aducanumab To Treat Alzheimer’s Disease
First novel therapy approved for AD in nearly 20 years was developed by Biogen and its Japanese partner Eisai.Charles Sternberg, Assistant Editor 06.08.21
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Biologics, Proteins, Vaccines | Drug Development
Addressing the Need for Standards in Cell and Gene Therapy
Identifying and understanding the areas with the greatest need for standardization to help the cell and gene industry progress.Robert Shaw, Robert Shaw Executive Director, Standards Coordinating Body for Regenerative Medicine 06.07.21
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APIs | Drug Development
Biocatalysis: An Indispensable Tool for API Synthesis
Biocatalytic processing offers a wealth of advantages and should be evaluated during early-stage drug development.Benzion Dolitzky, VP R&D, Wavelength Pharmaceuticals 06.07.21
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Aseptic Processing | Facilities | Fill/Finish
CEO Spotlight: Patrick Haffey, Selkirk
The chief executive talks about entering the fill/finish space as a CMO startup and the company’s new aseptic fill/finish facility.Tim Wright, Editor, Contract Pharma 06.07.21
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Clinical Trial Materials | Drug Development | Preclinical Outsourcing
Strategies for Entering Phase 1 Clinical Development with Limited API
Removing API supply as a criterion in the “Go/No-Go” decision tree and enhancing the opportunity to successfully navigate the pharmaceutical “Valley of Death.”Thomas Daggs and Angelo Consalvo, Enteris BioPharma 06.07.21
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Drug Development | Preclinical Outsourcing
Preparing for Preclinical Testing: A Readiness Checklist
As companies prepare for preclinical testing, they can use this checklist to make sure they are ready.Mark Walker, Senior Technical Director of Toxicology, WuXi AppTec Laboratory Testing Division 06.07.21
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Analytical Services | Bioanalytical Services | Drug Development | Laboratory Testing | R&D
CRO Industry Update
Digital modernization, decentralized trials and advanced therapies drive outsourcing.Kristin Brooks, Managing Editor, Contract Pharma 06.07.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
AGC Biologics Inks Supply Deal for COVID-19 Vaccine
CDMO’s Heidelberg facility to supply plasmid DNA for Pfizer/BioNTech COVID-19 vaccine.Tim Wright, Editor, Contract Pharma 06.07.21
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Waking from the “Coma of COVID-19”
What should the “New Normal” look like?Emil W. Ciurczak, DoraMaxx Consulting 06.07.21
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Information Technology | QA/QC | Regulatory Affairs
The Importance of Data Integrity Risk Assessment
Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.Paul Mason, Ph.D., Lachman Consultants 06.07.21
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Motivating Your Scientists and Engineers
It’s more than just money or stock.David G. Jensen, Contributing Editor 06.07.21
