EcompliancePlus

Breaking News | Clinical Trials

pHOXBIO Unveils Trial Results from COVID Prophylactic Nasal Spray

According to the study, the novel prophylactic nasal spray prevented infection from SARS-CoV-2, the virus that causes COVID-19.

09.22.21

Breaking News | Drug Development | Industry News

Veklury Reduced Risk of Hospitalization in High-Risk COVID-19 Patients

Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization.

09.22.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

CuriRx Launches CuriLytics Platform for Biotherapeutic Development

To provide CMC analytical services to support complex biotherapeutic development using high resolution mass spectrometry.

09.21.21

Biologics, Proteins, Vaccines | Reader Showcase

Thermo Fisher Launches Gibco AAV Production System

Aims to address the need to make adeno-associated virus (AAV) production more efficient and scalable.

09.20.21

Breaking News | cGMP Manufacture | Drug Development | Industry News

Everest Medicines, Sinovent, SinoMab Enter Global BTK Inhibitor Mfg. Pact

To develop, produce and commercialize XNW1011, a covalent reversible BTK inhibitor, globally for the treatment of renal diseases.

09.17.21

Breaking News | Facilities | Industry News | Inspections

Symbiosis Completes Successful MHRA Audit

Will expand facility at its Stirling, UK site with new storage and warehousing capability.

09.16.21

Drug Development | Laboratory Testing

Eliminating Endotoxins – Reagent Quality Testing for Cell and Gene Therapies

The importance of reagent quality control, especially endotoxin testing, during CGT development and the selection of reagents and suppliers to ensure safety.

Garrett Perry, Technical Services Specialists at Teknova 09.14.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

AbbVie, REGENXBIO Enter Eye Care Collaboration

Strategic partnership combines eye care and gene therapy expertise.

09.13.21

Breaking News | Formulation Development

AzurRx BioPharma Acquires First Wave Bio Inc.

Expands its GI development pipeline and positions itself for new growth opportunities in the inflammatory bowel disease therapeutic space.

09.13.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

UK Govt. Terminates Valneva COVID Vax Agreement

Valneva is continuing its VLA2001 development plan with Phase III results expected 4Q21 and potential MHRA approval in late 2021.

09.13.21

Breaking News | Promotions & Moves

Boyds Opens US Office in PA

Welcomes Katy Rudnick as VP and head of US regulatory affairs.

09.13.21

Biologics, Proteins, Vaccines

COVID Booster Vaccines: What’s Next for FDA

FDA Atty comments on the ongoing vaccine rollout what we can expect for other COVID vaccines in development going forward.

09.13.21

Bio News | Breaking News | Collaborations & Alliances | Drug Discovery | Industry News

Boehringer Ingelheim, Twist Bioscience Enter Antibody Discovery Collaboration

Research collaboration covers multiple antibody research programs.

09.10.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Repligen and Navigo Launch Antibody Technology Platform

Introduce industry-first protein A ligand for purification of pH sensitive antibodies.

09.10.21

Clinical Trials

The Future of Clinical Trials

Dr. Greg Licholai of ICON plc on key market trends, the future of clinical trials and the acquisition of PRA.

Kristin Brooks, Managing Editor 09.09.21

APIs | Drug Development

API Development Trends

Why is it important to consider solid form in API development?

John Mykytiuk, Jamie Marshall and Andrew Blythe-Dickens, Sterling Pharma Solutions 09.09.21

APIs | Solid Dosage/Creams/Ointments

Spray Drying: A Proven Approach to Enhance the Solubility of APIs

Spray drying is an established particle engineering technology that offers several advantages over other methods used for improving API bioavailability.

Benzion Dolitzky, PhD, VP R&D, Wavelength Pharmaceuticals 09.09.21

APIs | Clinical Trial Materials

Outsourcing the Manufacture of Clinical Trial APIs

What to consider when deciding to partner with a CDMO for manufacturing.

Josh Hoerner, General Manager, Purisys 09.09.21

Drug Delivery

Inhaled Drug Delivery Trends

Designing dry powder devices for inhaled drugs.

Andreas M. Meliniotis, Director of Device Development, Vectura 09.09.21

A Strong Partnership in Drug Development

How CDMOs and consultants mutually benefit their clients.

09.09.21

Clinical Trial Materials | Clinical Trials | Supply Chain

Clinical Trial Kitting

Overcome the challenges to make every sample count.

Claudia Berrón and Arbi Harootoonian, Avantor 09.09.21

Drug Development

Partnering with a CDMO for Orphan Drug Development

Challenges and considerations for advancing rare disease drugs to market.

Susan Billings, Vice President & Global Head of Business Development, Curia (formerly known as AMRI) 09.09.21

Analytical Services | Bioanalytical Services

Putting Laboratory Suppliers to the Test in the COVID Era – and Beyond

Build resiliency into analytical methods through careful consideration of chromatography partners.

Hazel Dickson, PhD, Marketing Manager, Chemistry Group, Waters Corporation 09.09.21

Choosing and Managing a CDMO

Speed up your time-to-market, keep development costs under control and smooth the FDA approval and commercial launch process.

Dana Toops, President, Avema Pharma Solutions 09.09.21

Global Outsourcing Trends

Lonza’s Jan Vertommen talks about building global manufacturing and development networks to advance innovative, life-saving therapies.

Tim Wright, Editor, Contract Pharma 09.09.21

cGMP Manufacture | Drug Development | QA/QC

Three Tips for Navigating Post-Approval Pharmacovigilance

Seamlessly transition from regulatory reporting to post-approval safety surveillance in today’s market.

Emmanuel Belabe, Associate Vice President, Safety Product Management, ArisGlobal, Nina Patel Lahanis, Associate Vice President, Safety Science, EVERSANA 09.08.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

CEVEC, UCB Ink AAV Mfg. Technology Agreement

UCB will use of CEVEC’s ELEVECTA AAV manufacturing technology in gene therapy.

09.07.21

Breaking News | Collaborations & Alliances | Drug Development | Drug Discovery

Adaptimmune, Genentech Enter Strategic R&D Collaboration

To research, develop, and commercialize cancer-targeted Allogeneic T-cell therapies.

09.07.21

Clinical Trials | Information Technology

Clinical Trials are Transforming Right Before Our Eyes

Decentralized clinical trials, an innovation just a short time ago, are now mainstream.

Kristin Brooks, Managing Editor, Contract Pharma 09.03.21

Aseptic Processing | Breaking News | Industry News | Promotions & Moves

Roberto Almodóvar Febles Joins Pii as Head of Aseptic Operations

Will oversee and manage day-to-day aseptic manufacturing.

09.03.21

Biologics, Proteins, Vaccines | Breaking News

Avantor Commences Multi-Year Investment in Global Hydration Capabilities

Completes a major expansion of its facility in Gliwice, Poland, and begins a multi-stage expansion of its facility in Aurora, Ohio.

08.31.21

Aseptic Processing | Breaking News | cGMP Manufacture | Promotions & Moves

Pii Names Head of Aseptic Operations

Roberto Almodóvar Febles will oversee and manage day-to-day aseptic manufacturing.

08.31.21

Breaking News | Industry News | Promotions & Moves

Forge Biologics Expands Leadership Team

Announces two key hires in process development and medical affairs.

08.30.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

iBio Enters AI Partnership with RubrYc Therapeutics

Secures option to license additional antibodies developed with RubrYc’s predictive algorithms.

08.26.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Pfizer, BioNTech Collaborate with Brazil’s Eurofarma to Manufacture Covid-19 Vaccines

The annual production is expected to exceed 100 million finished doses annually for Latin America.

08.26.21

Breaking News | Collaborations & Alliances | R&D

Roche, Shape Therapeutics Enter Strategic Gene Therapy Collaboration

ShapeTX will apply its RNA editing platform and leverage its AAVid technology platform for the development of gene therapy for various diseases.

08.25.21

APIs

Propofol – A Bachem Success Story

The COVID-19 pandemic has rapidly expanded awareness of the API Propofol, produced by Bachem in Vionnaz.

McMaster, Sartorius Enter Biomanufacturing Partnership

Team up to advance biomanufacturing processes with next-gen tech.

08.23.21

Bio News | Breaking News | Industry News

Pfizer to Acquire Trillium Therapeutics for $2.3B

Strengthens oncology portfolio with addition of next-generation, investigational immuno-therapeutics for hematological malignancies.

08.23.21

Bachem Capabilities to Address the New FDA Guideline for Synthetic Peptides

Scientific and regulatory challenges remain a big hurdle on the way to successful approval of generic drugs falling under this guideline.

CMO Becoming a Powerhouse With Expansions and New Facilities, Looking to Add Strategic Customers

Aphena is a service provider in the pharmaceutical, OTC, medical device, biologics and personal care industries.

APIs

Generic APIs Portfolio

With almost 50 years of expertise in peptide and small molecule synthesis, Bachem has an outstanding track record in large-scale manufacturing.

Breaking News | Industry News

Catalent, Edenbridge Pharma Enter Zydis Formulation Supply Agreement

Novel formulation of glycopyrrolate will use Catalent’s Zydis ODT delivery technology for adjunctive therapy for the treatment of peptic ulcer.

08.10.21

Breaking News | cGMP Manufacture | Drug Development | Promotions & Moves

Metrics Appoints Senior Director, Scientific and Technical Affairs

Anshul Gupte will be responsible for technical and scientific oversight of client projects, reporting to John Ross, President of Metrics Contract Services.

08.10.21

Breaking News | Industry News

KYOWA, Bora Pharmaceuticals Enter Mfg. Pact

Upon approval in Japan, Bora will be the commercial manufacturing site for the generic product production.

08.10.21

Breaking News | Financial Reports

BioNTech’s 2Q Revenue Soars

Growth due to rapid increases in the supply of BNT162b2 as BioNTech and Pfizer evaluate a third dose to boost efficacy against Delta variant.

08.09.21

Biologics, Proteins, Vaccines | cGMP Manufacture

A Look Into COVID Vaccines, Development and Outsourcing

Fiona Barry of PharmSource discusses COVID vaccines in development and CMO outsourcing trends.

08.09.21

Breaking News | Collaborations & Alliances | Industry News

Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum

The webinar series will focus on the benefits of 3D-Printing pharmaceutical medications.

08.05.21

The Real Cost of Bringing Manufacturing Home

Bikash Chatterjee of Pharmatech Associates discusses the reshoring trend, technologies and advances that could help deliver more manufacturing back to the U.S.

08.04.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Global Cell & Gene Therapy Mfg. Market Could Reach $57.4B by 2028

Market estimated to grow at CAGR of 20% from 2021 to 2028 due to an exponential rise in clinical pipeline along with rising number of regulatory approvals.

07.30.21

Breaking News | Drug Development | Industry News

Lantern Pharma Reacquires Irofulven from Allarity Therapeutics

Based on early Phase II results, Lantern to advance development in bladder and prostate cancer with a key mutation in the ERCC2/3 genes.

07.28.21

Breaking News | Collaborations & Alliances | Industry News

CatSci and Argonaute RNA Enter CMC Development Collaboration

Aim to expedite oligonucleotide manufacturing for gene-silencing therapeutics.

07.27.21

Breaking News | cGMP Manufacture | Industry News

WuXi Biologics Receives Manufacturing License from German Health Authorities

The inspections comprised areas of cGMP manufacturing required for receiving the permit, as well as commercial production approval.

07.26.21

Breaking News | Facilities

Capsida Biotherapeutics Opens Facility in Thousand Oaks

New 15,000 square-foot facility will enable industry leading end-to-end gene therapy manufacturing capability.

07.23.21

Breaking News | CRO News | Industry News

Calyx Expands US Presence in Response to Growing Demand

RTP-based US headquarters established to meet pharmaceutical companies’ and CROs’ increasing needs for e-clinical and regulatory solutions.

07.22.21

Breaking News | Promotions & Moves

TCR2 Therapeutics Appoints Chief Technical Officer

Peter Olagunju to oversee process development, manufacturing, quality control and technical operations for the company’s TRuC-T cell programs.

07.21.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Intravacc's Inactivated Polio Vaccine Out-licensed to Sinovac

Sinovac's Eupolio vaccine (sIPV) receives market authorization from the NMPA in China.

07.20.21

Clinical Trials | CRO News | Information Technology | Reader Showcase

Quanticate Launches Updated Remote Source Data Verification Platform

Cloud-based application allows verification of multiple clinical research sites’ source data to be completed remotely by specialist team at centralized location

07.19.21

Breaking News | Clinical Trials | Industry News | Information Technology

Calyx Opens U.S. HQ Near Research Triangle Park

RTP-based headquarters established to meet growing needs for eClinical and regulatory services.

07.19.21

Biogen

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07.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Clinical Trial Materials | Industry News

GentiBio, Forge Biologics Ink Development and Manufacturing Agreement

Partnership to support GentiBio’s cell therapy pipeline with AAV process development, scale up and GMP manufacturing services.

07.16.21

APIs | Breaking News | cGMP Manufacture | Industry News

MediPharm Labs Receives Canadian GMP Pharmaceutical DEL

License can be used for manufacturing, testing and sale of APIs and pharmaceutical drug products containing cannabis.

07.15.21

Breaking News | Collaborations & Alliances

Bicycle Therapeutics, Ionic Pharma Enter License & Collaboration Agreement

Will work together to develop targeted oligonucleotide therapeutics leveraging tissue-targeting TfR1 Bicycle technology.

07.13.21

Breaking News | Industry News

AMRI Becomes Curia

New brand reinforces ongoing expansion of expertise, capabilities and contributions to health care.

07.12.21

Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain

United States Pharmacopeia Acquires Pharmatech Associates

Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.

07.09.21

Analytical Services | Breaking News | Industry News | Laboratory Testing

LGM Pharma Launches Analytical Services for Drug Developers and Manufacturers

Analytical testing and stability services covers both drug substance and drug product.

07.08.21

Breaking News | cGMP Manufacture

Thermo Fisher Scientific Expands Gene Therapy Portfolio

Adds new set of solutions to support more efficient adeno-associated viral manufacturing.

07.07.21

Breaking News | cGMP Manufacture | Drug Development | Industry News

Hermes Pharma Announces Spin-out from Hermes Arzneimittel

CDMO specializes in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world.

07.02.21

Breaking News | Promotions & Moves

Avid Bioservices Appoints Esther M. Alegria to Board

Former SVP of global manufacturing at Biogen bring nearly 30 years of biopharmaceutical industry experience.

07.02.21

Breaking News | Collaborations & Alliances | Facilities | Industry News

WuXi STA Chooses Middletown Delaware for New Pharma Manufacturing Campus

The CDMO is bringing about 500 jobs to Middletown, with site expected to open in 2024.

06.29.21

APIs | Breaking News | cGMP Manufacture | Cytotoxics and High Potency Manufacturing | Industry News

Lonza Expands API Development, Mfg. Facility in China

20M CHF investment will include three 1,000L GMP trains and new development and GMP labs with HPAPI capabilities.

06.28.21

Analytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Drug Development

Host Cell Impurities, Bioassays, Micro-Flow Imaging

WHO, FDA and the European Pharmacopoeia have established strict regulatory guidelines to guarantee product quality in biologics.

Formulation Development

Tryp Therapeutics Partners with Alcami for Proprietary Formulations

The agreement represents another step toward the proprietary manufacturing, formulation, and delivery of products for Tryp’s PFNTM program.

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News | Process Development

Catalent to Acquire RheinCell Therapeutics

Strengthens path towards industrialization of induced pluripotent stem cell-based therapies.

06.25.21

Breaking News | Collaborations & Alliances

CellPoint and Lonza Enter CAR-T Cell Collaboration

Will work together to deliver CAR-T Cell therapies to patients at point-of-care.

06.24.21

Breaking News | Collaborations & Alliances

Cellenkos Chooses Cryoport to Support Covid-19 Therapy Shipments to Patients

Cryoport will provide tracking and proactive management for the therapies.

06.22.21

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.

Tim Wright, Editor, Contract Pharma 06.17.21

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

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

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

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.

Ocugen, Jubilant Enter COVID-19 Vaccine Partnership

Jubilant HollisterStier to manufacture COVAXIN for the U.S. and Canadian markets.

06.15.21

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

Enteris BioPharma Receives $10M Milestone from Cara Therapeutics

Third milestone payment related to the development of Oral KORSUVA.

06.11.21

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

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

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

Breaking News | Facilities | Industry News | Inspections

CPL Completes Successful Virtual Health Canada Audit

The CDMO created a virtual tour of its facilities in response to the pandemic.

Tim Wright, Editor, Contract Pharma 06.03.21

Clinical Trials | CRO News | Drug Development | Information Technology

Driving Efficiencies in Today’s Complex Trials

Murray Aitken of IQVIA discusses CRO market trends, post-pandemic opportunities, and leveraging tech-enabled services and capabilities.

Kristin Brooks, Managing Editor, Contract Pharma 06.03.21

Breaking News | Collaborations & Alliances | Industry News

PharmaBlock Sciences Partners with Shouyao Holdings

Will support CMC development and manufacturing of Shouyao’s second-generation ALK inhibitor for non-small cell lung cancer.

Charles Sternberg, Assistant Editor 06.03.21

APIs | Breaking News | cGMP Manufacture | Industry News

Onyx Scientific Receives Commercial API License for UK Facility

Allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.

Charles Sternberg, Assistant Editor 06.03.21

Clinical Trials | Drug Development

The Future is Decentralized: What This Means for Clinical Trial Sites

Benefits for research sites and how to prepare for decentralized trials.

Marc Leighton, Vice President of Product at Florence Healthcare 06.02.21

Bioanalytical Services | Bioassay Development | Biologics, Proteins, Vaccines

The Future of Continuous Bioprocessing

The modernization of advanced therapy manufacturing.

Dr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 06.02.21

Bioanalytical Services | Biologics, Proteins, Vaccines

The Future of Continuous Bioprocessing

The Modernization of Advanced Therapy Manufacturing

Dr. Karoline Hahn, Senior Consultant for Advanced Therapies, KCR 05.27.21

Breaking News | Collaborations & Alliances | Industry News

Hovione and iBET Form Strategic Collaboration

Will combine knowledge from both partners to create innovation in new therapeutic fields.

Tim Wright, Editor, Contract Pharma 05.27.21

Biologics, Proteins, Vaccines | Clinical Trials | Drug Development

Gene Therapy Trials

Critical regulatory and study start-up questions for gene therapy trials in the U.S., UK, and Europe.

April Marquick, Cell and Gene Therapy Expert, Premier Research 05.26.21

Breaking News | cGMP Manufacture | Industry News | Information Technology

Novatek Requalified as Supplier for Boehringer Aseptic Mfg. Facilities

Novatek's regulatory compliant quality solutions used at Boehringer for human pharma, animal health and biopharmaceutical sterile manufacturing sites.

Kristin Brooks 05.26.21

Breaking News | CRO News | Industry News

Premier Research Acquires Camargo Pharmaceutical Services

Expands product planning, development and differentiation services offered.

Tim Wright, Editor, Contract Pharma 05.21.21

Breaking News | Drug Development | Formulation Development | Industry News | Solid Dosage/Creams/Ointments

Recro, Astex Enter Drug Development Alliance

Expands partnership for oral solid dose drug product services.

Kristin Brooks 05.18.21

BioMedX Extends Collaboration with Merck

Merck will support up to six more research groups at the BioMed X Institute in Heidelberg within the next six years.

Charles Sternberg, Assistant Editor 05.17.21

Breaking News | Collaborations & Alliances | Industry News

Zynrelef Anesthetic Receives FDA Approval

Lifecore will manufacture the new innovative drug for treatment of postoperative pain.

Charles Sternberg, Assistant Editor 05.17.21

Humanigen Selects Chime Biologics as Manufacturing Partner

Ink manufacturing deal for COVID-19 therapeutic candidate lenzilumab.

Tim Wright, Editor, Contract Pharma 05.17.21

Breaking News | Cytotoxics and High Potency Manufacturing | Facilities | Industry News

Novasep Expands HPAPI Manufacturing Capacity

Responds to increasing customer demand for manufacturing services for antibody drug conjugates.

Tim Wright, Editor, Contract Pharma 05.13.21

Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News

Northwest Bio Seeks GMP Certification of Sawston Mfg. Facility

Upon initial license, production of GMP DCVax-L products in the Sawston facility may begin by the end of Q3.

Kristin Brooks 05.12.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

Novavax, Gavi Execute APA for COVID-19 Vax

Novavax to deliver 350 million doses beginning 3Q21.

Kristin Brooks, Contract Pharma 05.06.21

The Word ‘Innovation’ Probably Doesn’t Mean What You Think It Does

Innovation in manufacturing can come in many forms.

Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 05.05.21

The Changing Nature of Communications

Is Zoom burnout leading to a resurgence of the “good-ol” phone call?

David G. Jensen, Contributing Editor 05.05.21

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Shahid Manzur, Principal, EY Consulting 05.05.21

CDMO Market Trends & Opportunities

CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.

Tim Wright, Editor, Contract Pharma 05.05.21

Fast Track Automation in Pharmaceutical Manufacturing

Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and risk.

Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 05.05.21

Are Your Suppliers Supporting Your Growth?

The role of strategic sourcing and procurement for emerging biopharmaceutical companies.

Dave Stowe and Jonathan Horn, Tunnell Consulting 05.05.21

Bio News | Breaking News | Collaborations & Alliances | Industry News

BioVaxys Inks Deal with CDMO BioElpida

Includes clinical-grade bioproduction and aseptic packaging for ovarian cancer vaccine candidate BXV-0918A.

Tim Wright, Editor, Contract Pharma 05.05.21

Breaking News | Clinical Trials | CRO News | Information Technology

Syneos, Komodo Health Expand Data App Alliance

Leveraging Komodo’s Healthcare Map, Syneos aims to better analyze clinical, real-world, and commercial data.

Kristin Brooks 05.04.21

Clinical Trials | Information Technology | Promotions & Moves

Clinical Ink Adds Executives

CCO Chris Crucitti, COO Brian Donahue, and VP Project Operations Bill Barrasso to manage eSource platforms.

Kristin Brooks 05.04.21

Bio News | Breaking News | Facilities | Industry News

NuvOx Completes Construction of Expanded Manufacturing Facility

Will manufacture its lead product, NanO2, for clinical trials and commercial supply after FDA approval.

Tim Wright, Editor, Contract Pharma 05.03.21

AMRI Adds R&D and Mfg. Solutions for Orphan Products

Targeted investments globally expand scale and compound handling capabilities at facilities in Albany, Grafton, and Glasgow.

Kristin Brooks 04.30.21

Breaking News | Facilities | Fill/Finish | Industry News

Grand River Aseptic Manufacturing Earns Facility of the Year Award

Receives special recognition for operational agility during the pandemic.

Charles Sternberg, Assistant Editor 04.29.21

PPD to Expand GMP Lab in Ireland

Adding cell and gene therapy capabilities to support growing customer need.

Tim Wright, Editor, Contract Pharma 04.29.21

Breaking News | Collaborations & Alliances | Industry News

Elektrofi, Argenx Enter Collaboration and License Agreement

Will explore new subcutaneous formulations for therapeutic products directed at the human neonatal Fc receptor.

Charles Sternberg, Assistant Editor 04.27.21

Breaking News | Facilities | Industry News | Inspections

Bora Pharmaceuticals Completes Health Canada Inspection

Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.

Tim Wright, Editor, Contract Pharma 04.23.21

Breaking News | Drug Development | Drug Discovery

KemPharm Receives $10M Milestone for FDA Approval of Azstarys

Is eligible to receive an additional near-term $10 million milestone payment following DEA scheduling of SDX.

Charles Sternberg, Assistant Editor 04.22.21

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Valneva Focuses on Bilateral Discussions to Supply COVID-19 Vax

Looks to secure a supply agreement for the only inactivated vaccine candidate in clinical trials against COVID-19 in EU.

Kristin Brooks 04.22.21

CRO News

PRA Health Sciences Expands Pharmacovigilance Services

Offers post-marketing services for authorized COVID-19 vaccines and therapeutics, including PASS using Real World Solutions.

Kristin Brooks 04.22.21

Biologics, Proteins, Vaccines | Clinical Trials | Trials & Filings

Valneva’s Inactivated, Adjuvanted COVID-19 Vax Achieves Positive Data

VLA2001 was highly immunogenic with more than 90% of study participants developing significant levels of antibodies to SARS-CoV-2 virus spike protein.

Kristin Brooks 04.22.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

Resilience Acquires Ology Bioservices

Continues expansion with acquisition of biologics manufacturing company.

Tim Wright, Editor, Contract Pharma 04.19.21

Breaking News | Collaborations & Alliances | Industry News

Kintor, Visum Enter COVID-19 Manufacturing Partnership

To expand proxalutamide manufacturing for treatment of COVID-19 patients.

Tim Wright, Editor, Contract Pharma 04.19.21

Breaking News | Collaborations & Alliances | Industry News | Solid Dosage/Creams/Ointments

Recro, Ensysce Expand Development and Manufacturing Partnership

Additional contract broadens and further strengthens customer product portfolio.

Tim Wright, Editor, Contract Pharma 04.15.21

Breaking News | Industry News | Microbiology

Microbiologics Expands Virology Services

Increases capabilities and capacity to provide anti-infective testing, assay development and biomaterial production services for highly infectious pathogens.

Kristin Brooks 04.14.21

cGMP Manufacture | QA/QC

Ensuring Pharma Manufacturing Quality

How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.

Kristin Brooks, Contract Pharma 04.14.21

Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Microbiology

Vetter Development Service

With Vetter, you have a partner you can trust to support you throughout drug product development, clinical manufacturing and regulatory approval.

Aseptic Processing | Fill/Finish | Parenterals | Process Development | Scale-up/Technology Transfer

Vetter Commercial Manufacturing

Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.

AJILITY: Intelligent Drug Product Manufacturing

The AJILITY platform streamlines your drug product manufacturing program, helping you get lifesaving therapeutics to patients in less time with less complexity.

Breaking News | Collaborations & Alliances | Drug Delivery | Drug Development | Industry News

Kindeva Drug Delivery and Cambridge Healthcare Innovations Collaborate

Work together to develop and commercialize CHI’s novel dry-powder inhaler product.

Charles Sternberg, Assistant Editor 04.07.21

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

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

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

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

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Eloxx Pharmaceuticals Acquires Zikani Therapeutics

Combined company brings complementary Ribosomal RNA-targeted genetic therapy platforms together.

Kristin Brooks 04.01.21

APIs | Breaking News | cGMP Manufacture | Industry News

Piramal Pharma to Acquire Indian API Manufacturer Hemmo

Adds peptide API development and manufacturing capabilities for growing number of oncology and metabolic therapies.

Kristin Brooks 04.01.21

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

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Ajinomoto, Bright Peak Enter Immunocytokines Research Pact

Exclusive license agreement to incorporate Ajinomoto Co.’s AJICAP site-specific bioconjugation technology for the development of Bright Peak Immunocytokines.

Kristin Brooks 03.30.21

Biologics, Proteins, Vaccines | cGMP Manufacture

Advanced Analytics Advancing Development of Genetic Vaccines

Leveraging innovative advanced analytical technologies to ensure regulatory compliance in the development and production of novel vaccines.

Kristin Brooks, Managing Editor, Contract Pharma 03.29.21

Drug Delivery | Extractables and Leachables

E&L Considerations for Customized Syringe Delivery Systems

Join James Scull, Ph.D., Scientific Director for Element Life Sciences, to gain a deeper understanding of E&L evaluations of custom drug delivery devices.

03.29.21

cGMP Manufacture | Drug Development | Scale-up/Technology Transfer

Fast Track Automation in Pharmaceutical Manufacturing

Drug manufacturers turn to advanced automation technologies and project execution methodologies to reduce time, cost and risk

Steve Zarichniak, Technical Solutions Consultant, Honeywell Process Solutions 03.25.21

Breaking News | cGMP Manufacture | Formulation Development | Industry News

Piramal Pharma Solutions, Plus Therapeutics Ink MSA  

Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics’ RNL-Liposome Intermediate Drug Product.

Kristin Brooks 03.24.21

Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer

Plus Therapeutics, Piramal Ink Master Services Agreement

Development, manufacturing and supply deal is for Plus’ Rhenium NanoLiposome intermediate drug product.

Tim Wright, Editor, Contract Pharma 03.23.21

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

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

Promotions & Moves

Alcami Appoints Patrick D. Walsh as Chairman and Chief Executive Officer

He succeeds Walter J. Kaczmarek III, who is stepping down as Chief Executive Officer.

Breaking News | Clinical Trial Materials | Cold Chain Management | Industry News

PCI Pharma Services Expands Cold Chain Clinical Supply Storage

Adds significant capacity and several new cold chain storage conditions, which now include temperatures from controlled room temperature to -80°C.

Kristin Brooks 03.16.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Northwest Biotherapeutics Adds Production Capacity at UK Facility

Dendritic cell vaccine production capacity for personalized immune therapies increases from about 4 - 6 patients per month to about 40 - 45 patients per month.

Kristin Brooks 03.16.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Takeda and IDT Support Manufacturing of J&J’s COVID-19 Vaccine

Will make manufacturing capacity available at IDT’s facilities in Germany to manufacture the single-shot COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 03.15.21

Cytotoxics and High Potency Manufacturing | Facilities | Solid Dosage/Creams/Ointments

Outsourcing Solid Dosage Manufacturing

A Q&A with Dan Dobry, head of drug product commercial development at Lonza Pharma & Biotech.

Tim Wright, Editor, Contract Pharma 03.12.21

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

Breaking News | Collaborations & Alliances | Drug Development

Selexis SA and BITT Enter Service Agreement

Will develop the cell line for BITR2101, BITT’s lead tumor necrosis factor receptor 2 oncology candidate.

Charles Sternberg, Assistant Editor 03.10.21

Breaking News | Industry News

Generic Version of Symbicort Granted FDA Approval

Product is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).

Charles Sternberg, Assistant Editor 03.09.21

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

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

Breaking News | Industry News | Promotions & Moves

Sharp Appoints EU Qualified Person

Names Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services.

Tim Wright, Editor, Contract Pharma 03.09.21

Clinical Trials | Information Technology

Data Management Trends

Pandemic-fueled patient centricity is creating new challenges and opportunities for data management teams.

Deepu Joseph, Global Head & VP of Clinical Data Management 03.05.21

Combination Products & The CDMO Webinar - Watch Now On-Demand

During this webinar, regulatory and quality experts from Alcami provided insights into combination products and the latest regulatory guidance.

Breaking News

Fusion Pharmaceuticals Acquires IPN-1087

Expands its pipeline of potent alpha-emitting radiopharmaceuticals.

Charles Sternberg, Assistant Editor 03.02.21

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

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

Manufacturing Equipment Trends

Andreas Mattern of Syntegon Technology discusses latest technologies being leveraged in manufacturing equipment today.

Kristin Brooks 02.25.21

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

Catalent Acquires Delphi Genetics

Launches US plasmid manufacturing site to establish global pDNA development and manufacturing capabilities.

Tim Wright, Editor, Contract Pharma 02.23.21

Breaking News | Industry News | Information Technology

Antares Vision Agrees to Acquire rfXcel Corporation

rfXcel’s AI-enabled SaaS platform more than doubles Antares Vision’s software business and adds a high share of contracted, recurring and scalable revenues.

Charles Sternberg, Assistant Editor 02.19.21

Breaking News | Collaborations & Alliances | Drug Development

Lilly, Rigel Enter Exclusive CNS Development Collaboration

Lilly will pay $125 million upfront and up to $835 million in potential milestones for Rigel's lead RIPK1 inhibitor, R552.

Kristin Brooks 02.18.21

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Novavax, SK Bioscience Expand Vax Pact

The existing partnership for manufacture of NVX-CoV2373 has been expanded to increase production capacity and supply vaccines to the Korean Government.

Charles Sternberg, Assistant Editor 02.17.21

Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Drug Development

Biomunex, Onward Ink Strategic Antibody Development Pact

Exclusive worldwide license and development agreement will leverage Biomunex' next gen bi- and multi-specific antibody platform in hematological malignancies.

Kristin Brooks 02.16.21

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

AbbVie, Caribou Ink CAR-T Collaboration

Leverages Caribou's next-generation CRISPR genome editing technology platform and AbbVie's antigen-specific binders.

Tim Wright, Editor, Contract Pharma 02.10.21

Catalent, Trizell Enter Cell Therapy Deal

Sign development and manufacturing agreement with for macrophage-based advanced cell therapy.

Tim Wright, Editor, Contract Pharma 02.08.21

Biologics, Proteins, Vaccines | Breaking News | Industry News

CureVac, UK Partner on Vaccines Against SARS-CoV-2 Variants

Aims to mitigate the effects of the pandemic and help prepare against future SARS-CoV-2 outbreaks by working on multiple variant vaccines.

Kristin Brooks 02.05.21

Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development

The Future of Vaccines and Biologics

Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.

Kristin Brooks, Managing Editor, Contract Pharma 02.04.21

Breaking News | Drug Development | Industry News

Lilly Acquires Asahi Kasei’s Chronic Pain Candidate

To pay $20 million upfront and up to $210 million in potential milestones for AK1780, an orally bioavailable P2X7 receptor antagonist.

Kristin Brooks 02.01.21

Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine

Novartis to leverage manufacturing capacity and capabilities to address pandemic, supporting global supply of COVID-19 vaccine.

Tim Wright, Editor, Contract Pharma 01.29.21

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

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

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

Ajinomoto Bio-Pharma, Humanigen Expand Manufacturing Agreement

Ajinomoto will support fill finish for investigational COVID-19 therapeutic, lenzilumab, nearing completion of phase 3 study.

Tim Wright, Editor, Contract Pharma 01.27.21

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

Clinical Trials

The Future of Clinical Trials Series: Part II

Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.

Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21

Breaking News | cGMP Manufacture | Excipients | Industry News

PromoCell Receives EXCiPACT Certification

Manufactures pharmaceutical excipients to GMP standards for tailor-made cell culture media and reagents that fulfill specific regulatory requirements.

Kristin Brooks 01.26.21

Breaking News | Facilities | Industry News | Logistics | Packaging & Tracking

WDSrx Expands Warehouse Network

Pharma logistics company creates national network with expansion to Reno, NV.

Tim Wright, Editor, Contract Pharma 01.21.21

Analytical Services | Laboratory Testing

Improving Product Profitability

Using PAT/QbD/CM as tools to increase profitability of products.

Emil Ciurczak, Contributing Editor 01.21.21

Breaking News | Industry News | Information Technology | Validation

Global Biosciences Co. Selects ValGenesis VLMS

Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.

Contract Pharma Staff 01.20.21

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

Intravacc Completes Project for Provention Bio’s Vax Candidate

Potentially the first preventive vaccine for coxsackievirus B, a risk factor associated with type 1 diabetes and celiac disease.

Contract Pharma Staff 01.19.21

Breaking News | Clinical Trials | CRO News | Industry News

Frontage Bolsters Clinical Services Capabilities

Unveils plans to provide full service human radiolabeled absorption, metabolism, and excretion study capabilities.

Contract Pharma Staff 01.15.21

Your Pre-clinical Toxicology Program Needs a Strategy

At Syngene, we have developed a roadmap across pre-IND, IND and NDA that seamlessly integrate the various pre-clinical studies.

Chemical Development

Syngene has full value-chain Process Research and Development (PRD) capabilities for NCEs and advanced intermediates.

Breaking News | Collaborations & Alliances

Charles River Partners with JADE

Expands its biologics testing capabilities geographically and helps to accommodate demand for biologics therapeutics.

Contract Pharma Staff 01.14.21

Commercial Manufacturing

Syngene supports manufacturing of regulatory starting materials, APIs, HPAPI, NCEs and novel advanced intermediates.

Biologics, Proteins, Vaccines | Breaking News | Industry News

Botanical Solution Inc. to Supply Pharma Grade QS-21 Vaccine Adjuvant

Secures $3.3 million in funding with second round planned for Spring 2021 to bolster growth.

Contract Pharma Staff 01.06.21

The Importance of Food Studies in Pharmaceutical Development

Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.

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

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

3rd Medical Devices: Regulatory and Compliance Online Summit

...

01.04.21

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

INOVIO, Advaccine Enter Exclusive COVID-19 DNA Vax Pact

Partnership adds Asian manufacturing resource to INOVIO's global manufacturing consortium for INO-4800.

Contract Pharma Staff 01.04.21

Clinical Trials | Drug Development

Impact of Decentralized Trials in Oncology Drug Development

Join us on 2/9 as clinical, regulatory and real-world evidence experts discuss the impact of decentralized trials on the evolution of drug dev in oncology.

01.04.21

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.

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

BioNTech, Shanghai Fosun Pharma to Supply COVID-19 Vax to China

Sign an agreement to provide 100 million doses of their BNT162 mRNA-based vaccine candidate in 2021.

Contract Pharma Staff 12.18.20

ICP-MS - Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential

by Chris Williams, Julia Spraul (pictured), and Alyssa McBurney

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

CDMO Cognate BioServices Teams Up with L7 Informatics

To implement L7|ESP for integrated manufacturing and lab operations.

Contract Pharma Staff 12.16.20

CHA Biotech Launches Global CDMO Biz

Matica Biotechnology to construct GMP facility for viral vector production in Texas.

Contract Pharma Staff 12.16.20

Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.

Contract Pharma Staff 12.16.20

Breaking News | Industry News

AstraZeneca to Acquire Alexion in $39B Deal

Expands scientific presence in immunology by adding Alexion's innovative complement-technology platforms and strong pipeline, and top seller Soliris.

Contract Pharma Staff 12.14.20

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

Clinical Trials | Information Technology

Life Sciences Strive for Greater Agility

Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.

Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20

Breaking News | Promotions & Moves

ApiJect Systems Appoints General Counsel & Chief Compliance Officer

James A. Garrett joins the company with extensive legal and strategic business expertise.

Contract Pharma Staff 12.14.20

Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News

Orgenesis, Cure Therapeutics Form JV

Aims to advance point-of-care development and commercialization of cell and gene therapies.

Contract Pharma Staff 12.10.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

Boehringer to Acquire NBE-Therapeutics in €1.2B Transaction

Gains iADC platform and potential best-in-class antibody-drug conjugate (ADC) therapies for the treatment of solid tumors.

Contract Pharma Staff 12.10.20

Breaking News | Industry News | Trials & Filings

Health Canada Authorizes Pfizer, BioNTech COVID-19 Vax

Pfizer Canada and BioNTech will supply the Government of Canada a minimum of 20 million doses and up to 76 million doses of the vaccine through 2021.

Contract Pharma Staff 12.10.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News

Health Canada Green Lights COVID-19 Vax

Canadian regulator authorizes supply and emergency use of Pfizer and BioNTech’s COVID-19 mRNA vaccine.

Contract Pharma Staff 12.09.20

Breaking News | Excipients | Industry News | Parenterals

Evonik Bolsters Excipients Portfolio

Acquires Birmingham-based Lactel absorbable polymers from Durect Corporation.

Contract Pharma Staff 12.09.20

Breaking News | cGMP Manufacture | Industry News | QA/QC | Validation

UK’s VMIC to Implement Lonza’s MODA-EM

To digitize its Microbiology Quality Control operations.

Contract Pharma Staff 12.08.20

Breaking News | Facilities | Industry News | Information Technology

Samsung Biologics Launches Virtual Showroom

Provides key features and real-time construction updates of its recently announced Plant 4.

Contract Pharma Staff 12.07.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact

Will advance a new generation of antibody-drug conjugates towards clinical evaluation.

Contract Pharma Staff 12.03.20

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Trials & Filings

Pfizer, BioNTech Win First Authorization for COVID-19 Vax

MHRA authorizes supply of BNT162b2 vaccine for emergency supply; companies are ready to deliver the first doses to the U.K. immediately.

Contract Pharma Staff 12.02.20

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

Breaking News | Clinical Trials | Industry News

SGS Initiates U.S. COVID-19 Clinical Trials

Phase 2/3 trial will examine the safety, tolerability, and efficacy of Sarconeos (BIO101) to treat COVID-19 related respiratory failure.

Contract Pharma Staff 11.30.20

Life Science Success Podcast: Matt Hicks

...

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

Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News

AstraZeneca’s AZD1222 Meets Primary Endpoint in COVID-19

Two different dosing regimens demonstrated efficacy with one showing vaccine efficacy of 90% with no serious safety events noted.

Contract Pharma Staff 11.23.20

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

Breaking News | Industry News | Promotions & Moves

Frontida BioPharma Appoints EVP Technology

Dr. Praful Agrawala brings years of pharmaceutical product development leadership experience to the company.

Contract Pharma Staff 11.20.20

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

Bio News | Breaking News | Collaborations & Alliances | Industry News

Samsung Biologics Partners with Eli Lilly

Accelerates the delivery of Covid-19 antibody treatments.

Contract Pharma Staff 11.20.20

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

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

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

Collaborations & Alliances | Drug Development

XOMA Earns $2M Takeda Milestone

Mezagitamab advances into Phase 2 development in generalized myasthenia gravis.

Contract Pharma Staff 11.17.20

Information Technology | Supply Chain

The Pandemic & The Pharma Industry: 3 Things to Know

The importance of vendor contract visibility, an increase in intense legal scrutiny, and new technology for greater agility and control.

Colin Earl, CTO at Agiloft 11.16.20

Capsules | Solid Dosage/Creams/Ointments | Solid Dosage/Semi-solids

Double-blinding and removing bias with over-encapsulation

While there are many blinding options available, over-encapsulation remains the most popular method adopted by sponsors to meet regulatory demands.

Breaking News | Collaborations & Alliances | Industry News

Lead Pharma and Roche Enter Collaboration & License Agreement

Will develop oral small molecules to treat immune mediated diseases.

Contract Pharma Staff 11.16.20

Clinical Trials | Information Technology

eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

Clinical Outcome Assessments are an increasingly important tool in clinical research.

Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata 11.13.20

Preparing to Adopt Intelligent Label Management

The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.

Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA 11.13.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture

CCRM, MIP Partner to Build Biomanufacturing Campus

Aims to establish CDMO ops focused on regenerative medicine-based technologies and cell and gene therapies.

Contract Pharma Staff 11.13.20

Breaking News | Logistics | Packaging & Tracking | Supply Chain

Antares Vision Acquires Adents Traceability Assets

Expands portfolio of software solutions and cloud services for end-to-end traceability.

Contract Pharma Staff 11.13.20

Breaking News | Collaborations & Alliances | Industry News

AzurRx BioPharma Partners with Asymchem

Will develop and produce MS1819 for the treatment of exocrine pancreatic insufficiency.

Contract Pharma Staff 11.12.20

CCRM and McMaster Innovation Park (MIP) Partner to Build and Operate Biomanufacturing Campus

...

Breaking News | Industry News

Pfizer, BioNTech to Supply 200M Doses of BNT162b2 to EU

Deliveries are anticipated to start by the end of 2020, subject to clinical success and regulatory authorization.

Contract Pharma Staff 11.11.20

Breaking News | CRO News | Industry News | Information Technology

RhoFED Wins BARDA Contract

Will serve to standardize data collection, management, and analysis across BARDA-supported network studies.

Contract Pharma Staff 11.10.20

Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Facilities | Industry News

Novavax Expands Facility to Support Global Vaccine Development

Expands campus with two properties to support vaccine research and development, manufacturing, business operations.

Contract Pharma Staff 11.10.20

Pharmaceutical Logistics Company Expands in San Antonio

WDSrx expands into San Antonio providing pharmaceutical warehousing and logistics from 1310 Cornerway Boulevard.

Contract Pharma Staff 11.10.20

Breaking News | Industry News | Laboratory Testing

Dalton Pharma Services Expands Capabilities

Offers extractables and leachables testing services.

Contract Pharma Staff 11.10.20

Drug Delivery | Drug Development | Trials & Filings

Impel NeuroPharma Submits NDA for INP104 in Acute Migraine

Leverages the company’s Precision Olfactory Delivery technology

11.09.20

Breaking News | Drug Development | Promotions & Moves

Inozyme Pharma Appoints SVP, Regulatory Affairs

Dr. Kevin B. Johnson brings over 25 years of experience to the role.

Contract Pharma Staff 11.09.20

Excipients

Pharmaceutical Excipients Market Poised for Growth

The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.

Contract Pharma Staff 11.03.20

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters

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11.03.20

Breaking News | Industry News

Samsung Biologics, Checkpoint Therapeutics Expand Cosibelimab Mfg. Pact

Samsung Biologics will provide additional commercial-scale drug substance manufacturing.

Contract Pharma Staff 11.02.20

Bio News | Breaking News | Collaborations & Alliances | Industry News

Lonza to Manufacture AstraZeneca's COVID-19 Long-Acting Antibody Combination

cGMP manufacturing of the two long-acting antibodies to begin in H1 2021 at Lonza's Portsmouth, NH (USA) site.

Contract Pharma Staff 10.30.20

Breaking News | Clinical Trials | CRO News

BARDA Reselects ICON as Preferred Partner

Continues as part of BARDA’s exclusive Medical Countermeasures Clinical Studies Network

Contract Pharma Staff 10.29.20

Breaking News | Industry News | Promotions & Moves

Valicare Expands Service Portfolio

Recruits Dr. Christin Erbach as senior GMP consultant.

Contract Pharma Staff 10.28.20

The Future of Pharmaceutical Manufacturing: Multi-Product Facility and Equipment Design

Join us for a FREE webinar on November 12 at 11:00 AM EST.

10.26.20

Breaking News | Collaborations & Alliances

Elsevier, Novartis Collaborate on Risk Assessment Prediction Tool

To develop a safety margin risk assessment prediction tool, largely using PharmaPendium data.

Contract Pharma Staff 10.22.20

Breaking News | cGMP Manufacture | Drug Development | Industry News

Roche, Atea Pharma to Develop Potential Oral COVID-19 Treatment

To develop, manufacture and distribute AT-527, Atea’s investigational oral direct-acting antiviral being studied to treat COVID-19.

Contract Pharma Staff 10.22.20

Breaking News | Industry News | Packaging & Tracking | Serialization

TraceLink Launches Serialized Product Intelligence Solution

Allows companies to proactively monitor their serialized operations and gain actionable insights to avoid costly delays and ensure product availability.

Contract Pharma Staff 10.21.20

CDMO QCL Expands Fill Finish Capabilities

Partners with AST on flexible, isolated fill finish equipment for new facility expansion.

Contract Pharma Staff 10.21.20

Clinical Trials | Drug Development | Preclinical Outsourcing

Accelerating R&D Trends

The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.

Kristin Brooks, Contract Pharma 10.20.20

Breaking News | Clinical Trials | Collaborations & Alliances

Cytocom and Cleveland Biolabs Merge

Combine their businesses in an all-stock transaction.

Contract Pharma Staff 10.20.20

Breaking News | Clinical Trials

Mereo Makes Leadership Changes

Appoints CFO and SVP, regulatory affairs.

Contract Pharma Staff 10.20.20

Breaking News | cGMP Manufacture | Collaborations & Alliances | Facilities | Industry News

GSK to Sell Poznań Manufacturing Site to Delpharm

The CDMO acquires all facilities and gains approximately 700 manufacturing employees.

Contract Pharma Staff 10.15.20

Aseptic Processing | Fill/Finish

A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility

Overcoming today’s aseptic fill-and-finish process challenges.

Ute Schleyer, Project Manager, Site & Plant Development, Vetter 10.14.20

The Changing Approach to Design: Five Ways to Achieve Warp Speed

Revisiting facility design and construction based on today’s biopharmaceutical industry needs.

Jarrod Wrampe, Contributing Editor 10.14.20

Analytical Services | Bioanalytical Services | Breaking News | Industry News | Laboratory Testing

PPD to Open Multipurpose Clinical Research Lab in Suzhou

Will offer bioanalytical, biomarker and vaccine services for global and China-based biopharma customers.

10.14.20

Biologics, Proteins, Vaccines | Breaking News | Industry News

MilliporeSigma Launches VirusExpress Platform

Scalable platform increases dose yields and reduces process development time for cell and gene therapies.

10.13.20

Breaking News | Collaborations & Alliances | Industry News | Information Technology

U.S. Govt. Selects LabVantage’s LIMS

Walter Reed Army Research Inst. will use LIMS to support the production of vaccines for COVID-19 and other diseases.

Contract Pharma Staff 10.13.20

Clinical Trials | Information Technology

Adding Remote Site Access to Sponsor Bids: What to Know as CRO

Traditional monitoring has changed, CROs should build a portfolio of remote access solutions and have them ready.

Ryan Jones, CEO, Florence Healthcare 10.13.20

Drug Delivery

Topical Drugs Poised for Growth

The topical drug delivery market is projected to reach $129.8 billion by 2025 from $95.2 billion in 2020, at a CAGR of 6.4%.

Contract Pharma Staff 10.12.20

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

Breaking News | Promotions & Moves

Tergus Pharma Expands Executive Leadership

Appoints VP of quality and VP of manufacturing.

Contract Pharma Staff 10.06.20

Breaking News | Clinical Trial Materials | Collaborations & Alliances | Industry News | Preclinical Outsourcing

Ocugen Engages Kemwell Biopharma for cGMP Manufacture of OCU200

Paves the way towards getting OCU200 in the clinic by first half of 2022.

Contract Pharma Staff 10.06.20

Parenterals

Primary Packaging Considerations Amid COVID-19 Vax Urgency

Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.

Kristin Brooks, Contract Pharma 10.05.20

Breaking News | Collaborations & Alliances | Drug Development

Diamond Pharma Services Supports GenSight Biologics

Provides EU regulatory, pharmacovigilance, quality and compliance support for LUMEVOQ.

Contract Pharma Staff 10.05.20

Breaking News | Drug Development | Industry News | Information Technology

Dr. Reddy's Goes Paperless with ValGenesis VLMS

Digitizes validation process across multiple sites leveraging ValGenesis electronic validation lifecycle management system.

Contract Pharma Staff 10.05.20

Breaking News | Promotions & Moves

3P Expands Management Team

Adds José Luis Bartolomé as operational excellence and continuous improvement director.

Contract Pharma Staff 10.02.20

Breaking News | cGMP Manufacture | Fill/Finish | Industry News

CRB Completes Large-Scale Mfg. Facility for GRAM

GRAM's newest facility was designed to increase its large-scale fill and finish capacity for COVID-19 vaccines and therapeutics.

Contract Pharma Staff 10.01.20

Breaking News | Promotions & Moves

Aphena Appoints Quality and Regulatory Affairs VP

Matthew Prokopczyk brings 25 years of experience in the pharmaceutical industry in the areas of quality control, regulatory compliance and quality assurance.

Contract Pharma Staff 09.30.20

Breaking News | Promotions & Moves

Aprecia Appoints Regulatory Affairs SVP

Kathi Rinesmith to oversee strategic regulatory affairs for the company's expanding pipeline of 3D-printed pharmaceuticals.

Contract Pharma Staff 09.17.20

Cold Chain Management | Logistics | Supply Chain

Pharma Supply Chain Logistics & Potential COVID-19 Vaccines

Wes Wheeler of UPS Healthcare explores various complexities, how to minimize supply chain gaps and challenges across the nation and globally.

Kristin Brooks, Contract Pharma 09.17.20

Aseptic Processing | Drug Development

Why is the sterility of your drug product much more than just a test of sterility?

Join Contract Pharma and Nelson Labs for a FREE webinar on Wednesday, October 21 at 1:00 PM EDT to learn more.

09.16.20

Aseptic Processing | Lyophilization

Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products

This webinar from Lubrizol Life Science on Nov 4 will explore key considerations in designing and executing aseptic process simulations for lyophilized products

09.10.20

Biologics, Proteins, Vaccines | Breaking News | Promotions & Moves

Harpoon Therapeutics Appoints VP, Regulatory Affairs and Quality Assurance

Karin Ann Thacker brings 20 years of leadership experience.

Contract Pharma Staff 08.27.20

Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations

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08.20.20

Bright Path Laboratories selects TrackWise Digital QMS

Partners with Sparta Systems and Quartic.ai.

Contract Pharma Staff 08.12.20

Cold Chain Management | Industry News | Logistics | Packaging & Tracking | Supply Chain

Cryoport, Medipal Partner on Supply Chain Solutions for Japanese Market

Will partner to provide integrated distribution solutions for specialty cell and gene therapies that demand stringent temperature control.

Contract Pharma Staff 08.04.20

APIs | cGMP Manufacture | Clinical Trials | Supply Chain

Evaluating Pharma Amid COVID-19

Dr. Ural of Ernst & Young LLP discusses market dynamics, enduring therapeutic areas, near term M&A, and how industry can use this time for transformation

Kristin Brooks, Contract Pharma 05.18.20

cGMP Manufacture | Clinical Trials | Drug Development | Information Technology | R&D

COVID-19’s Long-Term Impact on Drug Development: The New Pragmatism

The rise of new tools and approaches, an increase in regulatory responsibility, and the need for speed.

Paul Bridges SVP Worldwide Head Regulatory & Access, Parexel and Sheela Hegde, Partner and Managing Director, Health Advances 05.18.20

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. territories

Contract Pharma Staff 05.18.20

Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News

WuXi Launches CAR-T Cell Therapy Platform

Will enable biotechnology companies and researchers to accelerate the development, manufacturing and release of cell and gene therapies for patients

Contract Pharma Staff 05.18.20

Breaking News | Facilities | Industry News | Inspections

PharmaCyte Conducts Final Audit of Mfg. Facility

Batch records in Thailand have been deemed cGMP compliant

Contract Pharma Staff 05.18.20

Breaking News | Industry News | Packaging & Tracking | Serialization | Solid Dosage/Semi-solids

Colorcon Launches SoteriaRx

An on-dose authentication technology platform designed to combat counterfeiting

Contract Pharma Staff 05.14.20

Breaking News | Collaborations & Alliances

Ori Biotech and CellGenix Collaborate

Promote innovation within closed-system cell and gene therapy manufacturing.

Contract Pharma Staff 05.13.20

cGMP Manufacture | CRO News | QA/QC

Parexel Launches COVID-19 Risk Mitigation Offering

Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemic

Contract Pharma Staff 05.13.20

Breaking News | Industry News

Gilead, Mylan Ink Global Remdesivir License Agreement

To supply Remdesivir for potential COVID-19 treatment in 127 low- and middle-income countries.

Contract Pharma Staff 05.12.20

Yourway and Firma Ink Clinical Supply Deal

Collaborate to administer coordinated supply delivery for home-health clinical trial visits

Contract Pharma Staff 05.12.20

Promotions & Moves

BioDelivery Sciences Appoints Interim CEO

Jeffrey Bailey has led both public and private healthcare companies leveraging his leadership experience in commercial, supply chain and business development

Contract Pharma Staff 05.11.20

Breaking News | Collaborations & Alliances | Industry News

Sterling Begins HCQ Production in UK

Partners with Accord Healthcare for the manufacture of potential COVID-19 treatment

Contract Pharma Staff 05.11.20

Promotions & Moves

CorMedix Appoints CFO

Matt David, M.D. has more than 15 years of experience in finance as a healthcare investment banker and earlier as an equity analyst covering the pharma sector

Contract Pharma Staff 05.11.20

Breaking News | Industry News