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BioWorld Today April 10, 2009
(BioWorld Today Via Acquire Media NewsEdge) , of Davis, Calif., and Advanta India Ltd., a seed company based in India, have entered into a research and commercial development agreement for the development of salt-tolerant sorghum. Under terms of the agreement, Advanta receives exclusive global rights to the use of Arcadia's salt-tolerance technology in sorghum. Arcadia receives an up-front payment, milestone payments and a share of commercial sales revenue. The agreement builds upon a January agreement between the two companies for the development of nitrogen use-efficient sorghum.
� BioAlliance Pharma SA, of Paris, said the FDA did not accept the new drug application for Loramyc (miconazole) mucoadhesive buccal tablet for filing based on the lack of a tablet imprint code. Loramyc was approved in Europe in 2007 and currently is marketed in several EU territories. While the EU does not require a unique tablet identifier, the FDA does require the code for drug identification purposes. Prior to the initial filing, BioAlliance initiated the development of a debossed tablet to fulfill tats requirement. BioAlliance said it will work with the FDA on the introduction of the debossed tablet and will soon after resubmit the Loramyc application.
� La Jolla Pharmaceutical Co., of San Diego, said an audit of its financial statements for the year ending Dec. 31, 2008, contained a going concern. The firm also reported that the Nasdaq stock market has informed it that the company is out of compliance because it has failed to maintain a minimum $10 million in stockholders' equity for continued listing. The firm has until April 20 to regain compliance.
� MonoSol Rx, of Warren, N.J., has submitted a new drug application to the FDA for the orally dissolving film strip (ODFS) formulation of ondansetron. The NDA is supported by positive data from pivotal studies in which ondansetron ODFS demonstrated bioequivalence against GlaxoSmithKline's Zofran ODT anti-emetic product. The ondansetron ODFS product has been developed as an anti-emetic therapy for the prevention of chemotherapy-induced nausea and vomiting, nausea and vomiting associated with radiotherapy, and postoperative nausea and vomiting.
� Neurogen Corp., of Branford, Conn., said its 2008 financial statements included in the company's annual report contained a going concern qualification.
� Tobira Therapeutics Inc., of Princeton, N.J., has initiated a proof-of-concept study for TAK-652, a CCR5 antagonist, in HIV-infected, antiretroviral therapy-experienced, CCR5-naive patients. The study is being conducted under an investigational new drug application filed with the FDA. The Phase IIa randomized, double-blind, placebo-controlled study will evaluate the antiviral activity, safety and pharmacokinetics of TAK-652 by enrolling 40 therapy-experienced, CCR5-naive HIV-1-infected patients into one of four escalating dose groups ranging from 25 mg to 100 mg once daily, administered for 10 days. Each dose group of the study will enroll 10 patients - eight receiving TAK-652 and two receiving placebo.
� Tolera Therapeutics Inc., of Kalamazoo, Mich., said the FDA granted orphan drug status to TOL101, which the firm is developing as a prophylaxis of acute rejection of solid organ transplantation. The biologic protein is designed to specifically target T cells, components of the immune system that play a key role in the rejection and ultimate failure of transplanted organs.
(c) 2009 Thomson BioWorld, All Rights Reserved.
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