The FDA rapped finished drugmaker Higiene + Salud for shoddy recordkeeping and deficient investigations after a November inspection of the company’s Toluca, Mexico facility. Source: Drug Industry Daily
A federal appeals court affirmed last week that Novartis did not engage in antitrust violations to protect a patent on its leukemia drug Gleevec (imatinib). Source: Drug Industry Daily
A coalition of health care stakeholders called on the FDA to issue final guidance on interchangeable biosimilars to help promote drug price competition, saying the agency’s failure to finalize its…
A panel of experts is urging the FDA to reconsider rigid rules excluding certain groups from clinical trials — or at least make decisions on a case-by-case basis. Source: Drug…
In its latest move to combat opioid abuse, the Justice Department slapped two Ohio doctors with restraining orders after a sting operation found they illegally prescribed opioid painkillers and other…
An appeals court Wednesday overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of its antidepressant drug Paxil (paroxetine). Source:…
Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if…
The FDA issued a warning letter to Hangzhou Karic Commodities and placed it on an import alert after an inspection of its Hangzhou, Zhejiang facility revealed numerous violations, including a…
Sen. Edward Markey (D-Mass.) is urging the FDA to overhaul the risk evaluation and mitigation strategy (REMS) program. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb announced Wednesday that the agency is hiring the National Academies of Sciences, Engineering and Medicine to help develop guidelines for opioid analgesic prescribing. Source: Drug Industry…