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The UK’s National Institute for Health and Care Excellence (NICE) said it will cover Johnson & Johnson subsidiary Janssen-Cilag’s diabetes drug Invokana (canagliflozin) as a treatment for people with type 2 diabetes. Read More
FDA advisors want more clinical data before recommending a green light for AstraZeneca’s latest ovarian cancer treatment, dealing a blow to the British drugmaker’s promising oncology pipeline. Read More
A federal judge tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More
A federal judge has dismissed conspiracy claims against four generic drugmakers and a brand firm in a class-action lawsuit that alleges the companies colluded to keep generic versions of Cephalon’s wakefulness drug Provigil off the market. Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
After an exhaustive review, the FDA found no clear evidence of higher cardiovascular risks for diabetic patients taking olmesartan, and declined to set new restrictions on use of the widely-prescribed hypertension drug. Read More
European regulators are advising drugmakers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements, and serious violations will face EU Phramacovigilance Risk Assessment Committee (PRAC) review. Read More
The FDA expects manufacturers of genetically engineered products that could be harmful if released into the wild to submit environmental assessments (EAs) along with their biologics applications. Read More