A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis.
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.
Home » MorphoSys Chief Says MOR103 Drug Data Makes Deal More Likely
MorphoSys Chief Says MOR103 Drug Data Makes Deal More Likely
MorphoSys has better chances of finding a partner for its experimental arthritis drug after favorable results from a clinical trial, CEO Simon Moroney said. The compound, named MOR103, would be the first proprietary compound for the Martinsried, Germany-based biotech company, which develops biological drugs for companies such as Roche Holding AG and Novartis AG. Bloomberg