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Drugmakers Sagent and Baxter Healthcare recently recalled products due to labeling mix-ups, a common quality problem that one expert says can be easily solved through an additional examination by personnel. Read More
A trade group of small to medium-sized European brand drugmakers has criticized a Spanish government order that may allow biosimilars to be interchanged with their reference product in the same way that generics may be substituted for brands. Read More
A UK healthcare cost watchdog has recommended against national coverage of Dendreon’s novel prostate cancer treatment Provenge, deeming it too expensive. Read More
Six months of additional pediatric exclusivity should be granted only to products that add a children-specific indication, and only if the drug sponsor receives a specific written request from the FDA for studies to support the label expansion, according to the American Academy of Pediatrics. Read More
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System. Read More
Joining pharma’s global transparency movement, members of a pharmaceutical association in Greece have committed to disclosing details of their financial interactions with healthcare professionals and organizations. But a loophole in such voluntary industry codes could diminish the impact of the reporting, critics say. Read More
UK’s healthcare cost watchdog has recommended against coverage of Celegene’s multiple myeloma drug Imnovid, in combination with dexamethasone, for treating MM patients who have failed on at least two previous treatments and whose disease has progressed on the last therapy. Read More