A pharmacy chain operator that brought antitrust class action lawsuits against more than a dozen generics manufacturers earlier this week has added three more — Actavis Holdco, Lannett and Epic…
The Association of the British Pharmaceutical Industry will run advertisements later this month in three medical journals listing Astellas UK and Gedeon Richter as in breach of the ABPI’s Code…
The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers,…
The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first…
China’s Food and Drug Administration only carried out a fraction of the dozens of planned GMP inspections of foreign sites last year. Source: Drug Industry Daily
The director of the U.S. Patent and Trademark Office announced her resignation this week, offering no explanation. Source: Drug Industry Daily
The House Energy and Commerce Committee voted 54-0 on Wednesday to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate,…
The FDA put drugmaker Yusef Manufacturing Laboratories on notice over failures to address batch discrepancies and other quality issues. Source: Drug Industry Daily
The Speaker of the Tennessee House wants the state’s attorney general to be the third in the nation to sue opioid manufacturers. Source: Drug Industry Daily
A pharmacy chain brought class action suits against 13 generics manufacturers — including Mylan, Sandoz, and Teva — claiming they conspired to raise prices of six drugs, including blood pressure…