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The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

Clinical Data on Moderna COVID-19 Vaccine Published

The agency is working to identify and obstruct scammers looking to profit from the pandemic.

FDA Protects Consumers Against COVID-19 Scams

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

EC Launches Structured Dialogue to Address Medicines Supply Vulnerabilities

A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry. 

Survey Demonstrates Upswing in Swedish Life Sciences Growth

The companies intend to design and implement algorithms for the early stages of research for drug discovery and development of drug candidates to treat Alzheimer’s disease.

Roche and Cambridge Quantum Computing Use Algorithms for Early Alzheimer's Drug Research

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

EMA Commences Rolling Review of Regdanvimab

Michael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.

Michael J. Hennessy: MM&M 40 Under 40 Award

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

The foundation will provide funding support for the discovery and development of a single-administration, in-vivo gene therapy to cure sickle cell disease, a hereditary blood disease.

Novartis and the Bill & Melinda Gates Foundation Team Up to Develop Gene Therapy for Sickle Cell Disease

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

Guidance Issued on Investigational COVID-19 Convalescent Plasma

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

PwC has teamed up with CPI on the Medicines Manufacturing Innovation Center to strengthen the UK’s position in advanced medicines manufacturing.

PwC Becomes Partner in Medicines Manufacturing Innovation Center

Connecticut Innovations has launched a campaign to highlight the growing companies, top talent, cutting-edge research, and quality of life in Connecticut’s life sciences ecosystem.

Connecticut Launches Life Sciences Ecosystem Marketing Initiative

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

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