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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
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
The FDA is concerned that patients will have trouble complying with instructions for Purdue Pharma’s oxycodone drug Avridi, as two advisory panels prepare to discuss the effect of food intake on the abuse-deterrent opioid. Read More