Industry News

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Chalmers University researchers have developed a method to label and track mRNA molecules.

The Cell and Gene Therapy Catapult will establish offices and laboratories in Edinburgh, Scotland.

The Council of Europe has appointed Petra Dörr, PhD, as the future director of the European Directorate for the Quality of Medicines and Healthcare (EDQM).

The University of Birmingham has been confirmed as the third National Training Centre in the Advanced Therapies Skills Training Network (ATSTN) initiative

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

RECOVERY trial results have shown that Regeneron’s investigational antibody combination therapy reduces the mortality risk for seronegative hospitalized patients with severe COVID-19.

The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

BIA has published a report presenting the findings of a survey on the public attitudes toward equal access to medicines for those living with rare diseases.

Optima has teamed up with the Robert-Bosch-Krankenhaus and Heidelberg University to develop a unit for decentralized, automated production of CAR-T cell therapies.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

The CGT Catapult has formed a consortium aimed at advancing the technology development and lowering costs of cell and gene therapy manufacturing.

FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

As COVID-19 continues to spread, industry leaders are banding together to stop the disease in its tracks.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19.