President Barack Obama didn't exactly set the biopharma world on fire with the 2015 State of the Union address, devoting only three sentences to drug research and development. What he did say, however – that the federal government will launch "a new precision medicine initiative to bring us closer to curing diseases like cancer and diabetes" – could add momentum to a flurry of dealmaking linking the use of biomarkers and genomic profiling to drug discovery and development. Read More
Two independent research teams have engineered microorganisms that are dependent on synthetic amino acids for their survival, making them unable to grow without a constant supply of synthetic nutrients. Read More
As company backers await data from the phase I trial with CUDC-907, due in June at the American Society of Clinical Oncology (ASCO), Curis Inc. signed an immuno-oncology deal that could be worth more than $100 million to Aurigene Discovery Technologies Ltd. Read More
To say the PTO is gun-shy of media coverage and controversy would be an understatement, if its Sensitive Application Warning System (SAWS) is any indication. Read More
Just last week, Celgene Corp.'s head of business development, George Golumbeski, told a packed breakout session at the annual J.P. Morgan Healthcare Conference in San Francisco that the firm's long-term pipeline "can never be big enough." Read More
DUBLIN – The EMA is seeking input from interested parties on the data disclosure aspects of the EU's Clinical Trial Regulation, the overarching piece of legislation that will, from around mid-next year, govern the conduct of clinical trials across the EU. Read More
Momenta Pharmaceuticals Inc., of Cambridge, Mass., said that in the wake of Tuesday's Supreme Court decision to remand a Copaxone (glatiramer acetate) patent infringement case (Teva Pharmaceuticals USA Inc. v. Sandoz Inc.) to the U.S. Court of Appeals for the Federal Circuit, it remained "optimistic" that an abbreviated new drug application for M356, a generic Copaxone it created with Sandoz Inc., "could be approved by the FDA in the near term." Read More
Kineta Inc., of Seattle, completed enrollment of its phase Ib proof-of-concept trial for psoriasis using its drug candidate, ShK-186, an immune-sparing therapeutic in development for a variety of autoimmune diseases. The study is designed to evaluate the effects of biweekly injections of ShK-186 for four weeks in patients with active plaque psoriasis. Read More
UCB SA, of Brussels, said the FDA has accepted for review the new drug application for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the EMA has validated for review the marketing authorization application for brivaracetam in the same proposed indication. Read More
