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 European Union’s drug regulator on November 19 advised that an experimental Covid-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.

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).

Lexington, Mass.-based Agenus withdrew the company’s Biologics License Application (BLA) for the PD-1 inhibitor balstilimab from the U.S. Food and Drug Administration.

Valneva SE commenced rolling submission for initial approval of the company’s COVID-19 vaccine candidate VLA2001 with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.

FDA

After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.

AstraZeneca’s Covid-19 vaccine carries a small extra risk of rare blood clots with low platelets after the first dose and no extra risk after the second, a study led and funded by the drugmaker showed on July 28, after worries over side effects.