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Other News To Note(BioWorld Today Via Acquire Media NewsEdge) • Aeterna Zentaris Inc., of Quebec City, was notified that it is not in compliance with the Nasdaq's $1 minimum bid price and has until Nov. 12 to regain compliance. Aeterna said it will monitor the price and consider its options. The notice will not impact the company's listing on the Nasdaq Global Market at this time. Shares of Aeterna (NASDAQ:AEZS) were down 6 cents Thursday, or 11 percent, closing at 48 cents Thursday. • Agilent Technologies Inc., of Santa Clara, Calif., will acquire Dako Denmark A/S, a cancer diagnostic company based in Glostrup, Denmark, for $2.2 billion, the largest acquisition in Agilent's history. Agilent seeks to boost its revenue and presence in life sciences. Dako produces antibodies, reagents, instruments and software for the cancer diagnostic market, and collaborates with major pharmaceutical companies to develop new companion diagnostic products. Its 2010 annual revenue was $340 million. • Ambit Biosciences Inc., of San Diego, and Teva Pharmaceutical Industries Ltd., of Jerusalem, cleared an investigational new drug application (IND) with the FDA for CEP-32496, a product in development for cancer. The IND was supported by preclinical studies published in the Journal of Medicinal Chemistry and Molecular Cancer Therapeuticsshowing that CEP-32496 was a selective and potent inhibitor of BRAF in cells, and had potent and sustained anti-tumor activity in xenograft models of melanoma and carcinoma. • The FDA approved generic versions of the blood thinner Plavix (clopidogrel bisulfate, Sanofi SA and Bristol-Myers Squibb Co.), which is approved to treat heart attack or stroke or partial or total blockage of an artery. Gate Pharmaceuticals, Mylan Pharmaceuticals Inc.andTeva Pharmaceuticals Industries Ltd. received FDA approval for 300 mg clopidogrel, and Apotex Corp., Aurobindo Pharma Ltd., Mylan, Roxane Laboratories, Sun Pharma, Teva and Torrent Pharmaceuticals Ltd. received approval for 75 mg clopidogrel. Separately, Mylan disclosed it was the first to file a substantially complete abbreviated new drug application containing a Paragraph IV certification for clopidogrel 300 mg and was awarded 180 days of marketing exclusivity in this strength. Plavix tablets, 75 mg and 300 mg, had U.S. sales of approximately $6.7 billion for the 12 months ending March 31, according to IMS Health. • The board of directors of Human Genome Sciences Inc., of Rockville, Maryland, unanimously declared that London-based GlaxoSmithKline plc's tender offer for all outstanding shares of HGS for $13 per share is inadequate because it undervalues the company. The board said the offer is not in the best interests of HGS and its stockholders, and recommended that stockholders reject the offer and not tender any shares to GSK. • Medgenics Inc., of Misgav, Israel, and San Francisco, said the FDA accepted its investigational new drug application for Epodure, authorizing it to proceed with a Phase IIb study of the compound for anemia in patients undergoing renal dialysis. Epodure is designed to produce and deliver erythropoietin on a sustained basis, using the company's biopump technology to sustain production and delivery of therapeutic proteins in patients using their own tissue. The multicenter, randomized trial to evaluate safety and efficacy will be the first in the U.S. to use the biopump technology. • pSivida Corp., of Watertown, Mass., said that warrants to purchase more than 2.7 million shares of pSivida common stock expired May 15. Those were the last warrants originally issued to Sandell Asset Management. The company is left with outstanding warrants to purchase 2.3 million shares, of which 1.7 million expire in July and the rest in January 2016. The company ended the first quarter with $16.5 million in cash, cash equivalents and marketable securities, and no debts. • Repros Therapeutics Inc., of The Woodlands, Texas, said the FDA has received its documentation for a special protocol assessment for Phase III pivotal studies of Androxal (enclomiphene), an oral therapy for hypogonadism. The FDA has 45 days to respond. Meanwhile, Repros plans to begin screening subjects next week in a separate 500-patient, open-label, safety study of Androxal. The company hopes to submit a new drug application around the end of 2013. • Ruga Corp., of Palo Alto, Calif., said it acquired an RAF kinase program to overcome the paradoxical activation of the MAPK pathway in tumors as part of its drug adaptation inhibitor program. Inhibition of B-RAF has broad therapeutic potential in indications such as melanoma, colon, ovarian and thyroid cancer. Terms were not disclosed. • Sagent Pharmaceuticals Inc., of Schaumburg, Ill., said it launched irinotecan injection, a generic form of Camptosar, New York-based Pfizer Inc.'s chemotherapy drug. The generic is available in two latex-free, preservative-free, single-dose vials and is indicated as second-line treatment, in combination with 5-fluorouracil and leucovorin, for patients with metastatic carcinoma of the colon or rectum. • Ventac Partners and the Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences (GIBH), formed Hong Kong-based CASiGEN Pharma Ltd. to develop treatments for diabetes and other metabolic disorders. CASiGEN received a worldwide exclusive license from GIBH giving it access to new drug candidates addressing unmet medical needs in the field. • Vertex Pharmaceuticals Inc., of Cambridge, Mass., began a new collaboration with the Crohn's and Colitis Foundation of Canada to identify underlying disease mechanisms of inflammatory bowel disease (IBD). Vertex and CCFC will jointly fund lead scientists at three Canadian academic centers over three years who are studying the role of bacteria in IBD and the body's response to imbalance of bacteria. (c) 2012 Thomson BioWorld, All Rights Reserved. |