News UK orders 5 million bird flu jabs for pandemic preparedness The UKHSA has taken steps to prepare for a possible bird flu outbreak by placing an order with Seqirus for millions of H5 vaccine doses.
News MHRA's stature undermined by lack of resources says pharma The MHRA isn't sufficiently funded to meet its obligations and that could threaten UK investment in life sciences, according to an ABPI report.
News Warning letter adds to Applied Tx run of bad news Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.
News FDA kicks off review of Cytokinetics' aficamten for HCM Cytokinetics should hear back from the FDA next September about its application for Camzyos rival aficamten in obstructive hypertrophic cardiomyopathy
News Deadline looms for post-Brexit label changes for UK meds The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements.
News BMS files legal challenge to HHS' 340B rebate decision Bristol-Myers Squibb has become the latest pharma in the US to file a legal challenge to a block on a 340B drug rebate model opposed by HRSA.
News Dexcom is first to join FDA/CMS health tech pilot The FDA has named Dexcom as the first company to take part in its TEMPO pilot, which aims to bring digital health tech to patients more quickly.
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