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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