The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.
CytRx has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.
For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.
While in China for the International Summit of Heads of Medicines Regulatory Agencies, FDA Commissioner Margaret Hamburg will meet with top Chinese regulatory officials about working cooperatively on drug and food safety.
FDA's Ophthalmic Devices Advisory Committee panel overwhelming recommended PMA approval of Alcon's ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.
Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.
The FDA has sent letters to 9 companies--all of which market drugs to treat ulcers in horses--warning that they are improperly selling the products without first obtaining FDA approval.
Roche's Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.
While the industry is fixated on whether Actavis will save Allergan from a hostile takeover by Valeant or whether Pfizer might be sizing up a run at Actavis, there was a development Thursday that holds huge upside potential for Actavis. That was the FDA's decision to reclassify Mallinckrodt's Concerta generic as not making the grade in equivalence.
For three years, Guido Rasi has been Europe's top pharma regulator, moving aggressively to restore the image of the European Medicines Agency. But his future there is now in doubt, sidelined by a colleague who was miffed that he was not picked for the job himself, the Financial Times reports.