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.

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the expanded approval of Kyowa Kirin Co. Ltd.’s Crysvita (burosumab) to include older adolescents and adults living with the rare disease X-linked hypophosphatemia.

The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending conditional marketing authorization of Novartis’ Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises, or pain crises, in patients with sickle cell disease aged 16 years and older.

Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.

Swiss drugmaker Novartis won a key European recommendation for the company’s gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.

Bristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.