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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
NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More
FDA enforcement of drug companies’ use of off-label promotion is being made more difficult by Amarin’s successful lawsuit against the agency and by a government website, ClinicalTrials.gov, a law professor says. Read More