In the latest acquisition of a U.S. biotech with promising oncology offerings by a Japanese company, Daiichi Sankyo Co. Ltd., of Tokyo, bought Plexxikon Inc., of Berkeley, Calif., and its promising melanoma drug PLX4032, for $805 million up front and near-term milestones of $130 million linked to approval of PLX4032. Read More
After a long and winding road, the FDA has at last given Forest Laboratories Inc. the green light to market Daliresp (roflumilast) in the U.S. to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of such flare-ups, which may include breathlessness, chronic cough and excessive production of phlegm leading to medical intervention, including hospitalization. Read More
WASHINGTON – Two government contracts that could be worth up to nearly $200 million each will inoculate Novavax Inc. and VaxInnate Inc. against some of the financial risks involved in getting their recombinant influenza vaccines through clinical development. Read More
After a roller coaster February, in which shares of Tengion Inc. rose on buyout speculation only to fall after the surge in trading activity scared off a potential acquirer, investors of the East Norriton, Pa.-based regenerative medicine firm have stepped up with some much-needed financing. Read More
Poniard Pharmaceuticals Inc., of San Francisco, received approval from the Chinese State Food and Drug Administration to conduct two Phase III trials of its lead product candidate, picoplatin, in the treatment of second-line small-cell lung cancer (SCLC) and second-line ovarian cancer. The approval will allow Poniard to include Chinese clinical sites in global registration trials within those disease settings. Picoplatin, a platinum-based chemotherapeutic agent, has demonstrated promising clinical activity in SCLC and ovarian cancer, the company said. Read More
Pluristem Therapeutics Inc., of Haifa, Israel, and the Berlin-Brandenburg Center for Regenerative Therapies, in cooperation with the Charite-University of Medicine in Berlin, reported positive results from a preclinical study demonstrating that local administration of Pluristem's PLX cells following muscle injury resulted in significant improvement in the recovery of muscle function when compared with the control group. Study data indicated PLX cells can be used in accidental injuries, such as athletic injuries, as well as intentional injuries, such as the incision of skeletal muscle during surgery. Read More
