News FDA advisors split on Biogen’s ALS therapy But unanimous vote on biomarker validity could support accelerated approval of tofersen.
News MHRA unveils big shakeup in UK clinical trials regs Reforms will make applications streamlined and flexible without affecting safety, says agency.
News GSK wins the vote contest in FDA’s RSV vaccine panels Advisory committee votes unanimously that RSVPreF3 shot is effective, and 10-2 on safety.
News Pfizer’s RSV shot clears FDA adcomm; now it’s GSK’s turn There was debate about cases of Guillain Barré and the population of the phase 3 RENOIR trial.
News Santhera shores up funding ahead of vamorolone verdict The FDA is due to deliver a verdict on vamorolone in Duchenne muscular dystrophy in October.
R&D Healthcare brands are caught in a data privacy trap The digital advertising industry must adapt or accept the consequences of compliance failures.
News GBL joins CVC in €10.7bn takeover bid for Recordati A consortium of investors has made a €10.7bn offer to take Italian pharma Recordati private, but some analysts are sceptical the deal will go through.
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