When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
23andMe has stopped advertising its personal genetic test after a strongly worded rebuke from the FDA, Reuters reports, but the company is still selling its $99 kit despite the agency's demands.
Endoscopic device maker Xlumena has CE Mark approval in the EU for its AXIOS gastrointestinal stent and delivery system--but the endoscopic devices haven't yet cleared the FDA for sale in the U.S. To that end, the company has secured a fresh infusion of capital--$25 million.
Every time the FDA has discussed compounding pharmacies and the need to keep fake drugs out of the supply chain in recent years, one message has shone through--we need more power. Now, the FDA is being given some, but not all, of the powers it wants, and has begun to discuss how it plans to use its new authority.
When Wockhardt reported financial results in October, regulatory slapdowns in the U.S. and Europe made for a bleak quarter. Now, things are about to get much worse. The FDA has filed an import alert against the plant that generates 25% of Wockhardt's sales.
As Gilead nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, most recently Idenix Pharmaceuticals, which claims the blockbuster hopeful infringes on its patents.
The FDA has delayed a decision on Biogen Idec's hemophilia B therapy Alprolix.
The Obama administration says Medicare drug discounts have saved U.S. recipients $8.9 billion so far in prescription drug costs. Of course, the more they save, the less drugmakers earn, since they are the ones having to pony up the discounts, which the Obama administration is looking to make even larger.
Now that the FDA has fired off a strongly worded rebuke of its Personal Genome Service, 23andMe is standing by the accuracy of its un-approved test, promising to work with regulators but giving no indication that it'll stop selling its sole product.
A morning-after contraceptive pill sold in Europe may not work in women who weigh more than 176 pounds, regulators there said, triggering an FDA review of Teva Pharmaceutical's PlanB One-Step product and its generic versions.