By Barbara Obstoj-Cardwell. Editor
US Food and Drug Administration-related stories were a feature of last week’s news. First up, AstraZeneca revealed that, as its supportive clinical trial – aimed at converting an accelerated approval to full approval – had failed, and it was therefore withdrawing the bladder cancer indication for its Imfinzi in the USA. There was positive news for Regeneron and partner Sanofi last Monday, when they gained FDA approval for their Libtayo in the treatment of lung cancer. However, bluebird bio revealed that the FDA has put a clinical hold on its gene therapy LentiGlobin for the treatment of sickle cell disease, due to the emergence of serious adverse events that might be linked to the drug. Meantime, on the M&A front, US pharma giant Merck & Co announced that it was acquiring autoimmune drug developer Pandion Therapeutics.
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