India's Ranbaxy Laboratories has issued another recall for its generic Lipitor, but a series of product recalls in recent weeks have come from plants around the world and companies as varied as Pfizer, Mylan and Gilead Sciences.
Mainstay Medical won approval from Ethics Committees in Australia to begin a clinical trial of its implantable neuromodulation device.
This week FDA officially introduced its push to open up its data to the public and particularly app developers. The unveiling went over the goals of openFDA, but also detailed some other areas in which the agency is investing. FDA is pushing hard into NGS and cloud-based genomics.
While most drugs from India are generics, sometimes Indian products are used by Big Pharma for their top brands, like AstraZeneca's Nexium.
Sleep drugs have been the root of plenty of safety worries over the years, especially when it comes to driving while under their influence. Now, just a week after the wrap of one of the highest-profile cases to revolve around Ambien generic zolpidem--Kerry Kennedy's--the European Medicines Agency's Pharmacovigilance Risk Assessment Committee is recommending updates to its product information to underscore the drug's associated risks.
AngioDynamics is gearing up for commercialization in the coming year for its latest chronic dialysis cathether, a product that will help protect and grow an already impressive U.S. market presence.
Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.
On Thursday, Novartis won European approval for its injectable Xolair to treat chronic hives--the first such product cleared there for patients who don't respond to antihistamines alone.
The largest drugstore chains have been in a legal battle with Pfizer, accusing it of conspiring to keep generics of its antidepressant Effexor XR out of their stores for years. Now they will have to deal with losing some of the real thing. Pfizer is recalling three lots of the drug after a pharmacist discovered a capsule of one of Pfizer's heart pills in an Effexor XR bottle, a potentially fatal combo.
When Baxter International issued product recalls in December and January, it said there had been no reports of adverse events. But Baxter couldn't make that claim Wednesday when the company recalled a single lot of a dialysis product in which mold was found.