In passing PDUFA V, Congress piled on the homework for the FDA, and much of it has nothing to do with user fees. Some of the assignments, for instance, deal with implementing incentives for new antibiotics. Read More
A post-market study by Acorda Therapeutics Inc. designed to compare a lower 5-mg dose of Ampyra (dalfampridine) to the approved 10-mg dose failed to show any benefit for the 5-mg dose and missed its primary endpoint altogether at both doses. The drug is approved for use in patients with multiple sclerosis. Read More
DUBLIN, Ireland – Elan Corp. plc is hiving off its early stage neurology drug discovery activity into a new entity, Neotope Biosciences, which will begin life with $120 million to $130 million in cash and seek a listing on an as yet to be determined U.S. exchange. Read More
These days, the emergence of resistance to targeted therapies, with the result that such targeted therapies often produce remissions that are spectacular but ultimately short lived, are in the headlines. Read More
• Arrowhead Research Corp., of Pasadena, Calif., plans to raise $6.2 million through a registered direct offering of common stock and warrants. Read More
• NPS Pharmaceuticals Inc., of Bedminster, N.J., said that the Prescription Drug User Fee Act action date for its NDA for Gattex (teduglutide) for the treatment of adult patients with short bowel syndrome has been extended by three months to Dec. 30. Read More
• Protalix BioTherapeutics Inc., of Carmiel, Israel, received clearance from the FDA to begin trials of PRX-102, a candidate for Fabry disease. It plans to begin enrolling patients in a Phase I/II study in the fourth quarter. PRX-102 is designed to potentially be an improved version of currently marketed enzyme replacement therapies for Fabry. Read More
• Sun Pharmaceutical Industries Ltd., of Mumbai, India, will acquire Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., for $39.50 in cash per share paid to shareholders other than Sun Pharma and its affiliates, which currently own about 66 percent of outstanding ordinary shares and 100 percent of founders shares. Read More
• Neuralstem Inc., of Rockville, Md., has been issued U.S. Patent No. 12/710,097, "Transplantation of Human Neural Cells for Treatment of Neurodegenerative Conditions." The patent covers the process of culturing central nervous system cells and transplanting them into spinal cord tissue to treat neurodegenerative disorders, such as amytrophic lateral sclerosis. Read More
