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Branded drugmakers have expressed guarded optimism at the announcement of high-level intellectual property talks between the U.S. and India, hoping the discussions will resolve long-standing worries over a lack of effective patent protection by the Indian government. Read More
The UK’s healthcare cost watchdog has recommended against covering Roche’s leukemia drug Gazyvaro for chronic lymphocytic leukemia (CLL) patients who are ineligible for fludarabine-based therapy. Read More
Better postmarket surveillance of generic drugs and a greater understanding of the bioequivalence of hard-to-compare products will top the FDA’s regulatory science priorities under GDUFA in the new fiscal year, the agency said. Read More
The Centers for Medicare and Medicaid Services said it will soon improve the functionality of its week-old physician payments website, but so far it’s not taking action on drug industry concerns that such payments lack vital context. Read More
Allergan’s eye implant therapy Ozurdex can now be used on the entire diabetic macular edema (DME) patient population, following an FDA expansion of the product’s indication this week. Read More
European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults. Read More
Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
The FDA has issued guidance on using social media for approved products, but the agency has been markedly silent on how drugmakers can use Facebook, Twitter and other platforms for drug development, an expert said. Read More
In a defeat for the pharmaceutical industry, a federal appeals court has upheld a California county ordinance that requires drug manufacturers to collect and dispose of unwanted medicines, a program that advocates say will serve as a national model. Read More