Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. 

PTC Therapeutics Inc. announced that the company completed the Scientific Advisory Group and Oral Explanation meetings for its gene therapy treatment for AADC deficiency (PTC-AADC) with the Committee for Advanced Therapies (CAT).

Merck

Merck announced that the company will lay off 170 people from Cambridge, Massachusetts-based Acceleron Pharma, which was acquired during November 2021 for about $11.5 billion.

Pharma giant AbbVie and Iceland-based Alvotech settled a case filed with the International Trade Commission. The dispute centered around Alvotech’s adalimumab biosimilar drug, which AbbVie posited had been developed through theft of trade secrets of the company’s Humira product.

The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the Marketing Authorization Application for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab).

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.

The United States Department of Defense (DOD) awarded Moderna a contract valued at $1,966,598,000 for an additional 100 million doses of the company’s Covid-19 vaccine.

CHMP Recommends Approval of Lilly’s Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis — Positive Opinion is the First Regulatory Action for Baricitinib as an Atopic Dermatitis Medicine INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency’s (EMA) Committee for […]

bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.

San Diego-based Ligand Pharmaceuticals is acquiring San Diego-based Pfenex for a total deal transaction of up to $516 million.