FDA has cited a number of unresolved consumer safety concerns in GlaxoSmithKline's Rx-to-OTC switch application for weight-loss drug Alli (Xenical/orlistat 60 mg) stemming from self-selection issues observed in the drug's actual use study
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.
President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.
HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.
