News First MHRA/NICE aligned guidance due in June The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April.
News Novo rapped by FDA for not reporting drug adverse effects Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.
News FDA cuts testing requirements for biosimilars once again The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
News CBER chief Vinay Prasad to leave FDA once again For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.
News PepGen slumps as FDA places hold on lead drug Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.
News Hansa closes on FDA verdict for transplant drug imlifidase The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.
News Novo sues Lilly over 'misleading' GLP-1 ad campaigning The rivalry between Novo Nordisk and Eli Lilly in the GLP-1 market has spilled over into the courts in the US, with claims of misleading advertising.
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