Common stock in Fibrocell Science Inc., of Exton, Pa., has been approved for listing on the NYSE Market, to commence trading on May 17, under the ticker symbol FCSC. The FDA approved Tarceva (erlotinib) tablets for first-line treatment of metastatic non-small-cell lung cancer characterized by tumors with epidermal growth factor receptor-activating mutations. The product is marketed by Genentech Inc., a member of the Basel, Switzerland-based Roche Group, and Astellas Pharma Inc., of Tokyo. In

Merck Serono SA, of Rockland, Mass., a division of Merck KGaA, of Darmstadt, Germany, and Quintiles Inc., of Research Triangle Park, N.C., signed a new, five-year clinical development agreement. Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy. Quintiles will also contribute to Merck Serono's future trial design process. The two companies will share decision-making responsibility for the Merck Serono portfolio. Mylan

The pulse of the National Institutes of Health (NIH) could weaken without a healthy injection of money to fund future innovations and the scientists who form the core of biomedical research. "This is a perilous moment" for both the NIH and the future of innovative research, NIH Director Francis Collins told a Senate Appropriations subcommittee Wednesday as he pushed for more funding for the agency. NIH has lost 22 percent of its purchasing power over the past decade, and the number of grants it

Embryonic stem cells have been the subject of so many political fights that it's easy to forget they have also faced formidable scientific obstacles. But they have. Human eggs, it turns out, are far more fragile than those of most other mammals – including those of other primates. And so, methods that have been used to clone mammals from Dolly the sheep to Snuppy, the cloned dog that was South Korean stem cell scientist Woo-Suk Hwang's only non-fraudulent claim to fame, have failed to produce

Bayer HealthCare Pharmaceuticals Inc., of Berkeley, Calif., and Onyx Pharmaceuticals Inc., of South San Francisco, said the FDA approved Bayer's Stivarga (regorafenib) for metastatic gastrointestinal stromal tumor previously treated with imatinib mesylate and sunitinib malate. Stivarga was previously approved for metastatic colorectal cancer. Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., enrolled their first patients in Phase III COMPARE and ASCERTAIN trials of

Jennerex Biotherapeutics Inc., of San Francisco, said data demonstrating the ability of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anticancer immunity, both in patients with diverse solid tumor types and in animal models has been published in the May 15 issue of Science Translational Medicine. The paper described findings from a Phase I study evaluating the safety and efficacy of Pexa-Vec after an intratumoral administration in patients with

The American Society of Clinical Oncology (ASCO) released the first of more than 4,700 abstracts late Wednesday in anticipation of its 2013 annual meeting, scheduled to attract more than 30,000 participants to Chicago from May 31 to June 4. Early abstracts highlighted by ASCO at a Wednesday afternoon press conference suggested a significant focus this year will be advances in cancer immunotherapies, including inhibitors of PD-L1 and PD-1. Roy S. Herbst, professor of medicine at Yale University

Algeta ASA and partner Bayer AG disclosed FDA approval Wednesday for Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer, with the agency's nod coming three months ahead of the Aug. 14 PDUFA date. Xofigo, an alpha particle-emitting radioactive therapeutic agent, was approved based on data showing that the drug produced an overall survival benefit with antitumor effects on bone metastases. "We're actually delighted," Algeta CEO Andrew Kay told BioWorld Today. "This is a

Development of Tokai Pharmaceuticals Inc.'s triple-acting prostate cancer drug galeterone got a $35.5 million boost, with the Cambridge, Mass.-based biotech closing a Series E round with current investors Apple Tree Partners and Novartis Venture Funds, as well as undisclosed angel investors. Proceeds will go toward expanding the ongoing Phase II ARMOR2 study into patients with castration-resistant prostate cancer (CRPC) and preparing for registrational trials. The company could not be reached

Gradalis Inc.'s interim Phase II data with its personalized cancer vaccine for advanced ovarian cancer showed the approach more than doubled the benefit in patients given therapy known as FANG, a rough acronym for "furin and granulocyte-macrophage colony-stimulating factor (GMCSF)." The trial, which has enrolled 17, treated 12 with FANG plus standard treatment and five with only the standard treatment, which consists of surgery and chemotherapy, with an eye on the primary endpoint of time to

Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution. The drug has orphan status for use in improving neurological outcome in adults with subarachnoid hemorrhage. Prior to the approval of Nymalize, nimodipine was available only in gel capsule form. Arbor said it will launch the drug in the next few months. Cempra Inc., of Chapel Hill, N.C., signed an exclusive license and development agreement for oral solithromycin

Pearl Therapeutics Inc. launched its much-anticipated Phase III (PINNACLE) trial of PT003, a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered by pressurized hydrofluoroalkane, in chronic obstructive pulmonary disease (COPD). The Redwood City, Calif.-based company raised $65 million in a Series D financing in November to support the trial. (See BioWorld Today, Nov. 14, 2012.) The product is a combination of a long-acting muscarinic antagonist (LAMA), glycopyrrolate

AbbVie Inc.'s $70 million up front buys an option to acquire Alvine Pharmaceuticals Inc.'s drug candidate for celiac disease or the company itself, after Phase IIb trials are finished with ALV003, a two-enzyme combo that degrades gluten. The 500-patient Phase IIb study with ALV003, which is composed of a cysteine protease and a prolyl endopeptidase, should be finished late next year or early in 2015, said James Watson, chief business officer of San Carlos, Calif.-based Alvine. "It's starting

PharmaMar SA, of Madrid, Spain, a subsidiary of Zeltia, said it completed a Phase Ib trial testing PM01183 in combination with doxorubicin, with the combination displaying antitumor activity in all types of cancer included in the study. Complete and partial radiological remissions were observed in patients with small-cell lung, bladder, breast, endometrial and ovarian cancers, neuroendocrine tumors and synovial sarcoma. The company is planning a potential pivotal trial in small-cell lung cancer

Cosmo Pharmaceuticals SpA landed a hefty chunk of upside, that all-too-elusive commodity, by grossing $89.2 million from a sale of Santarus Inc. stock. The transaction will enable the already-profitable company to begin paying dividends to its shareholders. The Lainate, Italy-based drug delivery specialist disposed of 4.25 million shares, priced at $18.25 per share, Friday. On Monday, Jefferies LLC, which underwrote the offering, exercised its option to purchase an additional 637,500 Santarus

Astellas Pharma Inc. jumped on the bandwagon of big pharma restructurings, disclosing plans to close U.S. units OSI Pharmaceuticals LLC and Perseid Therapeutics LLC this year and to downsize Astellas Research Institute of America LLC to focus on central nervous system therapies. The company also plans to terminate its in-house fermentation research and, by fiscal 2015, to fold the operations of its Kashima facility in Osaka into other sites, including its Tsukuba (Japan) Research Center. Last