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The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
Pfizer is facing at least three class action lawsuits alleging that the company went to extraordinary, fraudulent lengths to maintain exclusivity over its multibillion dollar arthritis pain drug Celebrex and keep generic competitors off the market. Read More
The race to create an abuse-deterrent version of a once-daily analgesic is heating up, with Purdue Pharma taking the lead in its competition with Zogenix’s controversial painkiller Zohydro ER. Read More
The FDA has asked Gilead Sciences to remove a sponsored link on Google that misrepresents the drugmaker’s hepatitis B drug, Viread, and omits risk information, the first such enforcement action since the agency issued guidance on character-limited advertisements last month. Read More
Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation. Read More
Clinical research firm Clinipace Worldwide wants the FDA to sign off on a generic version of Merck’s osteoporosis drug Fosamax by declaring that three strengths of the drug were not discontinued for safety or effectiveness reasons. Read More