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Two FDA advisory committees voted 23 to 1 on Thursday not to recommend approval of Purdue Pharma’s NDA for Avridi, saying the public health benefits of the abuse-deterrent opioid don’t outweigh the risks to patients posed by the effect of food intake. Read More
A pair of U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act Wednesday. Read More
An Alabama compounder is recalling all of its nonexpired drug products over possible contamination issues and stopped production of sterile compounds on Sept. 1 after the FDA received reports of adverse events. Read More
Otsuka Pharmaceutical and Proteus Digital Health announced Thursday FDA acceptance of their first-of-its-kind digital medicine NDA combining Abilify with a digital tracking mechanism. Read More
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
Concordia Healthcare is acquiring UK-based Amdipharm Mercury for $3.5 billion, in a deal that greatly expands the Canadian drugmaker’s generic portfolio and global reach. Read More
GlaxoSmithKline’s Breo Ellipta failed to meet its primary goal in a pivotal clinical trial of curbing death risk in patients suffering from chronic pulmonary obstructive disease. Read More
Drug and biologics makers are urging the Centers for Medicare & Medicaid Services to reimburse each noninterchangeable biosimilar based on its own average sale price, saying that would avoid prescribing mix-ups and possible harm to patient care. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
Citing a recent federal court ruling that truthful off-label claims are protected free speech, Pacira Pharmaceuticals has sued the FDA, claiming a First Amendment right to promote its Exparel postsurgical non-opioid analgesic for unproven uses. Read More