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A federal judge has dismissed some claims in a case alleging Teva and Pfizer-subsidiary Wyeth forged an anticompetitive agreement to delay generic competition on Wyeth’s antidepressant Effexor XR. Read More
Sponsors of research into cell therapies should conduct preclinical studies either in vitro or in animals to address potential risks and methods of delivery before initiating investigations into the use of the products, according to new recommendations from Health Canada. Read More
Regeneron Pharmaceuticals’ eye injection Eylea received an expanded indication from the FDA to cover macular edema following branch retinal vein occlusion. Read More
Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER. Read More
The FDA late Tuesday unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
The FDA extended an indication for AbbVie’s Humira to treat childhood arthritis in younger patients, marking another win for the drugmaker seeking to get as much out of the blockbuster biologic before its patents start expiring in two years. Read More
Bristol-Myers Squibb has withdrawn its NDA for a hepatitis C combination drug of Daclinza and asunaprevir, citing concerns of an insufficient target population. Read More
European regulators are greatly expanding a public database for reporting suspected adverse drug reactions, adding roughly 1,700 more products to the site, the European Medicines Agency said. Read More
Australian regulators are urging tougher warnings on the cardiovascular risks of over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), as well as proposing new initiatives to better inform patients about CV risks associated with both the OTC and prescription-based painkillers. Read More
The FDA has clarified what types of drug development topics it will accept for a critical path innovation meeting (CPIM), stressing again that the agency won’t give advice on individual submissions during a CPIM. Read More
The FDA is turning up the heat on drugmakers who don’t pay their generic drug user fees, warning its tenth manufacturer since the summer for delinquent fees. Read More
Limiting the concentration of OTC pediatric acetaminophen liquid drugs to 160mg/5mL would mitigate the risk of patients overdosing on the common products to reduce pain and fever, the FDA says. Read More