Drug Industry Daily

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The FDA has informed Gilead Sciences it needs at least three more months to weigh its Truvada sNDA for HIV prevention, AIDS advocates say.

Drugmakers can help secure the global supply chain from counterfeits and cargo theft by mapping their network of suppliers to better assess their risks and prioritize mitigation, industry groups say.

Mylan can commence U.S. generic sales of the sleep disorder drug Provigil on Aug. 10, ahead of the expiry of the 180-day marketing exclusivity period granted Teva by the FDA, under a settlement reached by the two companies.

House Republicans sought Friday to turn up the heat on an investigation into alleged collusion between PhRMA and the White House to ensure passage of President Barack Obama’s health reform law, releasing emails and other documents they say support their case.

Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions.

The FDA has granted orphan drug status to CSL Behring’s investigational Hemophilia B treatment, a biologic that could allow patients to receive fewer injections to prevent potential bleeding events.