By Barbara Obstoj-Cardwell. Editor
Regulatory news last week included the US Food and Drug Administration granting approval for AstraZeneca and Merck & Co’s Lynparza, for an important new indication in breast cancer. Following disappointing Phase III clinical trial results, Nektar Therapeutics and Bristol Myers Squibb have decided to discontinue enrolment in the study of bempegaldesleukin (bempeg) with Opdivo in the treatment of melanoma. Japan’s Eisai has significantly revised its licensing deal with Biogen on the controversially approved Alzheimer’s disease drug Aduhelm, retreating from a major role and instead concentrating on the development of lecanemab. US RNAi specialist Alnylam is suing Pfizer and Moderna for patent infringement, seeking to gain a share of the massive profits that have been made by their respective COVID-19 vaccines, Comirnaty and Spikevax.
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