News

FDA Accepts Genentech’s Application for Bispecific Antibody to Treat Eye Diseases

August 03, 2021

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

EC Makes Supply Agreement with GSK and Vir Biotechnology for mAb COVID-19 Treatment

August 03, 2021

The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

DisperSol and Catalent Announce Manufacturing Collaboration

August 03, 2021

DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.

FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions

August 03, 2021

FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

Working Towards Zero Emissions

August 02, 2021

Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.

Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment

August 02, 2021

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA Approves Interchangeable Biosimilar Insulin

August 02, 2021

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

Regeneron and AstraZeneca Partner to Create Small-Molecule Obesity Drug

August 02, 2021

Regeneron and AstraZeneca have entered an agreement to create a small-molecule medicine designed to treat obesity.

FDA Approves GSK’s Treatment for Chronic Rhinosinusitis with Nasal Polyps

August 02, 2021

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

Drug Pricing Scrutiny Increases in Europe

August 02, 2021

Excessive drug pricing is being scrutinized across Europe, as hefty fines are set to send out a clear message of intolerance to anti-competition conduct.