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RxNews Recap for Wednesday 11-18-09
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Affymax, Inc. (Nasdaq: AFFY), today announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering.Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced new pre-clinical data from its ALN-VSP program presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics International conference being held November 15 - 19, 2009 in Boston, Mass.BSD Medical Corporation (NASDAQ: BSDM) (www.bsdmedical.com) today provided an update on the U.S. Food and Drug Administration’s (FDA) review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 Hyperthermia System.Clinical Data, Inc. (NASDAQ: CLDA) today announced that it has enrolled the first patient in its initial Phase III trial of Stedivaze™, a potential best-in-class vasodilator for use in cardiac stress testing.Delcath Systems, Inc. (Nasdaq: DCTH) announced today the closing of its public offering of 9,775,000 shares of common stock priced to the public at $3.60 per share.CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.Depomed, Inc. (NASDAQ:DEPO) announced today that William Callahan has been promoted to vice president, Operations. Mr. Callahan joined Depomed in 2002 and most recently held the position of senior director, Operations.Exelixis, Inc. (Nasdaq:EXEL) today reported interim data from an ongoing phase 1 dose-escalation trial of XL147 (SAR245408) in combination with the EGFR inhibitor erlotinib in patients with advanced solid tumors.PPD, Inc. (NASDAQ:PPDI) today announced it has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company that provides a broad range of integrated services to biopharmaceutical companies. The acquisition will expand PPD’s drug development capabilities in China.Pfizer Inc (NYSE:PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children. Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP), a specialty pharmaceutical company, today announced the pricing of a public offering of 5,500,000 shares of its common stock.Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported data from two nonclinical studies of voreloxin at the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics Conference, which is being held in Boston, MA from November 15-19, 2009.Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today presented new data on the mechanism of action of elesclomol, a first-in-class oxidative stress inducer, at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston, Mass.Tongjitang Chinese Medicines Company (NYSE: TCM) (“Tongjitang” or the “Company”), a leading specialty pharmaceutical company focusing on the development, manufacturing, marketing and selling of modernized traditional Chinese medicine in China, today announced its financial results for the quarter ended September 30, 2009 and the repurchase of ordinary shares in a private transaction.YM BioSciences Inc. (NYSE Amex: YMI; TSX: YM), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, announced that results from a study evaluating nimotuzumab were presented today in a poster at the 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference in Boston, Massachusetts.
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Good FDA News for Nuvo Research (TSX:NRI) and Sunesis (Nasdaq: SNSS)
Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug (NSAID) used for the treatment of the signs and symptoms of osteoarthritis of the knee. Nuvo develops drug products delivered to and through the skin using its topical and transdermal drug delivery technologies.
{tiny;TSX:NRI;3}“FDA approval of Pennsaid is the most significant milestone in Nuvo’s history,” said Dan Chicoine, Chairman of Nuvo Research. “We are thrilled that we have been able to successfully navigate a very challenging regulatory pathway for this product and look forward to the upcoming launch of Pennsaid in the U.S. by Covidien. This will support the development of our product pipeline as we progress toward becoming the global leader in the research and development of drug products delivered to or through the skin.”“Building on more than a century of pain treatment experience, Covidien is focused on expanding the limits of pain therapy by combining proven drugs with innovative delivery systems,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “We are pleased to be collaborating with Nuvo Research on this opportunity to expand our branded pharmaceutical portfolio by selling and marketing Pennsaid throughout the United States.”
Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions.In June, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into a license and development agreement with Nuvo that encompasses Pennsaid Topical Solution and its follow-on topical diclofenac formulation, Pennsaid® Plus Gel, which is currently under development. As a result of the FDA approval of Pennsaid Topical Solution, Nuvo will receive a $15 million milestone payment from Covidien. Going forward, Nuvo will receive royalties on net U.S. sales of Pennsaid at rates that are consistent with industry standards. Nuvo will also be eligible to receive additional escalating sales milestone payments for Pennsaid and Pennsaid Plus totaling up to $100 million.
{tiny;SNSS;3}Elswhere, Sunesis Pharmaceuticals (Nasdaq: SNSS) today announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML). Sunesis is currently conducting two Phase 2 clinical trials of voreloxin in AML: a single-agent study, known as REVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely to benefit from standard induction chemotherapy and a study evaluating voreloxin in combination with cytarabine in relapsed/refractory AML.
"This designation recognizes the acute need for more options in treating this poor-prognosis disease," stated Steven B. Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "We believe voreloxin has the potential to impact the standard of care for AML and we continue to be encouraged by our progress. We are finalizing a registration strategy for voreloxin in AML and anticipate launching a pivotal trial in 2010."
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval and an exemption from user fees.
Vinny Cassano, a contributor to BioMedReports, who authors VFC's Stockhouse blog and is Long NRIFF has this to say about the news:
Investors were disappointed with the price action of the NRIFF stock (just under fifty cents) at Thursday's open before dipping down to the low forty cent range, but that action is in line with the recent price action of stocks that have just received FDA approvals. In my opinion, in this market investors and traders are more impatient than ever and are willing to take advantage of anticipatory, short term spikes before an approval decision (in order to bank some quick profits) before then changing course and going long after the drop that occurs at the point of "sell the news."It's a manipulative game, in my opinion - BioDelivery Sciences International, Inc.(NASDAQ:BDSI) got beat down, for instance, on Wednesday after starting to run early in the day - but it's also a game that can also benefit the small investor just as much as it benefits the big boys.It's a lot less gut-wrenching to buy a stock for a decent price when you know the approval is in place rather than having to be all-in at decision time when you're sweating the decision. In the case of NRIFF, at this point patience is needed. The drug will not be launched until the first half of 2010, so if you can get in for a decent price now and have the patience to hang one - I think that at least a double could be in order by launch time. I'm not expecting too much more than that for now, but the risk of this investment just dropped significantly; with an approved product and a strong partner, NRIFF is a pretty safe bet to rise. |
