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Roche will increase research and development efforts on two Alzheimer’s drugs that suffered setbacks in trials last year, as the race for a potential cure heats up. Read More
The Critical Path Institute has formed the Global Pediatric Clinical Trials Network Pre-Launch Consortium to facilitate treatments for infants, children and adolescents — a top FDA priority. Read More
Biosimilars makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing, the Federal Circuit Court of Appeals ruled Tuesday — in a decision that bars Sandoz from marketing its Neupogen biosimilar until Sept. 2. Read More
Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma was construed solely for that purpose. Read More
The FDA published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More
Relying on a U.S. Supreme Court precedent involving Actavis, the Third Circuit Court of Appeals ruled June 26 that patent settlements in pay-for-delay cases can face antitrust scrutiny even if they do not include cash. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Brazil’s antitrust watchdog has fined Eli Lilly and its local affiliate $11.7 million for filing contradictory and misleading lawsuits in Brazilian courts to maintain exclusive rights to its cancer drug Gemzar. Read More