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The FTC Thursday asked the Supreme Court to take up and overturn an 11th Circuit Court’s decision that upheld the legality of reverse patent settlements between branded drug makers and generic competitors.
GlaxoSmithKline (GSK) and Medicines Co. separately ended development of investigational drugs last week, with GSK pulling the plug on a complicated urinary tract infection (cUTI) treatment.
Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Thursday.
Sponsors of clinical studies for antimicrobial drugs to treat acute bacterial sinusitis (ABS) should use superiority trials and demonstrate that the candidate affects the clinical course of the disease, according to finalized FDA guidance on the topic.
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