LONDON – Glybera formally became the first gene therapy to be approved in a regulated market, as the European Commission gave the rubber stamp to the treatment for the ultra-rare inherited disorder lipoprotein lipase deficiency (LPL) on Friday. Read More
Not every day do you see a company, in the course of developing its drug, sign a deal with two other firms that are working on a therapy in the same class. Even more unusual: The deal is designed to help come up with a reversing agent for both compounds, and others. Read More
Dendreon Corp. reported its third-quarter earnings, handing in a net loss of $154.9 million, or $1.04 per share. That loss was larger than consensus estimates. Provenge (sipuleucel-T) revenues also fell short of consensus, at $78 million, vs. $80.7 million. Read More
LONDON – Four Pfizer Inc. scientists and executives have formed a new company specializing in inflammatory and allergic diseases around assets deemed surplus to requirements following the closure of the U.S. pharma company's UK R&D center in Sandwich, Kent. Read More
The Supreme Court is expected to hear oral arguments in Amgen Inc. v. Connecticut Retirement Plans and Trust Funds, in which the big biotech is appealing a decision from the Court of Appeals for the Ninth Circuit that upheld a federal district court's refusal to hear evidence rebutting fraud-on-the-market claims involving erythropoietins before it certified a class in the shareholder lawsuit. Read More
• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it will receive a $1.25 million contingent payment from Pfizer Inc., of New York, triggered by Pfizer's decision to advance the antiscarring therapy EXC 001 into a Phase II study. Read More
• Affymax Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Co. Ltd., of Osaka, Japan, disclosed presented exploratory post-hoc subgroup analyses of the EMERALD Phase III studies that evaluated Omontys (peginesatide) for injection, an erythropoiesis-stimulating agent for the treatment of anemia due to chronic kidney disease in adult dialysis patients. Read More
• Isconova AB, of Uppsala, Sweden, carried out a fully subscribed rights issue of about SEK50 million (US$7.4 million) to finance clinical trials in-house, increase production capacity and continue research in new indications for the adjuvant Matrix M. Read More
• Bristol-Myers Squibb Co., of New York, said the National Institute of Health and Clinical Excellence decided to recommend Yervoy (ipilimumab), which is approved in Europe for treating advanced metastatic melanoma, within the final appraisal determination. Read More
Researchers at Stanford University and the Gladstone Institutes have identified a new target in the fight against amyotrophic lateral sclerosis, or ALS. Read More
