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The UK’s health care costs regulator is overhauling its recommendations for management of stroke risk in patients with atrial fibrillation, recommending physicians turn to three new generation anticoagulants rather than commonly-used warfarin or aspirin. Read More
Injectables maker Hospira is facing yet another recall after a customer found particulates embedded in a vial of 0.5 percent Marcaine painkiller. Read More
Novartis is hoping a federal judge will dismiss a Department of Justice kickback lawsuit against it based on the drugmaker’s argument that the government hasn’t shown a cause-and-effect relationship between the alleged kickbacks to pharmacies and increased sales of its products. Read More
Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
SAN DIEGO — The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move that agency officials say will cost manufacturers a small amount but will pay off in the potential for fewer inspections. Read More
Drugmakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitations that Twitter imposes on each message, the FDA says. Read More
The FDA says drugmakers have no obligation to correct misleading statements or claims made about their products by third-parties on social media, on websites and in online forums – even on websites owned by the drugmaker. Read More
Australia’s pharmaceutical regulatory body is looking to Europe for guidance on drug development, including clinical development of similar biological drugs, investigations of lipid disorder therapies and evaluations of bacterial infections. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. And they urged drugmakers to step up their involvement. Read More