Industry News

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out?

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

The Federal Trade Commission is launching a broad review of drug-company mergers, with an eye to examining how such actions can harm competition in the biopharmaceutical industry.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

With no final nomination of FDA commissioner coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs.

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

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

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

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.

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.

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

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.

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

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.

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.

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.

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

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

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

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.

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

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

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

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.

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

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.