FDA committe supports Pozen trial. Somaxon shares surge ahead of earnings Print E-mail
By BioMedReports.com Staff   
Friday, 05 November 2010 18:54

Below is a look at some of the headlines for companies that made news in the healthcare sector on November 5, 2010.

After the bell Friday, GlaxoSmithKline (NYSE:GSK) and XenoPort, Inc. (Nasdaq:XNPT) announced that the U.S. Food and Drug Administration (FDA) has accepted for review GSK’s response to FDA’s Complete Response letter for Horizant Extended-Release Tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). FDA has designated the resubmission as a Class 2 response and set a new Prescription Drug User Fee Act goal date of April 6, 2011.

Last month, GSK submitted its response to questions raised by FDA in a Complete Response letter dated February 17, 2010. GSK’s response to FDA included new data from nonclinical studies of Horizant and two epidemiology studies, conducted by GSK, exploring gabapentin use and cancer based on the UK General Practice Research Database. The resubmission also included a final safety update that provided updated or new safety information on patients in clinical studies who have been treated with Horizant.

POZEN Inc. (NASDAQ:POZN) reported today that an FDA advisory committee has voted to support the companys' late stage trial design for an experimental compound, PA32540. The potential treatment is indicated for the prevention of cardiovascular disease in patients that are susceptible to gastric ulcers caused by aspirin. Shares of Pozen rose 17 cents to $6.63.

Shares of Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) rallied more than 23% Friday on no apparent news. Volume of 3.7 million shares propelled the stock up 60 cents to $3.19. The company is expected to report Q3 earnings after the bell on Tuesday, November 9th. Somaxon’s product Silenor® (doxepin), indicated for the treatment of insomnia, was approved by FDA earlier this year.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM) an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it has won a $2 million medical device distribution bid for a new rural healthcare construction project supported by China Development Bank Corp. Shares rose more than 13% on the news.

Also Friday:

BIOLASE Technology, Inc. (NASDAQ: BLTI) the world's leading dental laser company, announced today that it has regained compliance with the audit committee requirements for continued listing on The Nasdaq Capital Market following the recent appointment of Gregory E. Lichtwardt to the Company's Board of Directors and Audit Committee.

Cadence Pharmaceuticals, Inc. (Nasdaq:CADX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting, today reported financial results for the three and nine months ended September 30, 2010.

Clarient, Inc. (Nasdaq:CLRT) announced today that its board of directors has unanimously agreed to recommend that Clarient stockholders tender their shares to General Electric Company (NYSE:GE) at the previously announced price of $5.00 per share of Clarient's common stock and $20.00 per share of Clarient's Series A Convertible Preferred Stock.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the Credit Suisse 2010 Health Care Conference, Phoenix, AZ on November 11, 2010 at 1:30 p.m. ET.

Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the third quarter ended September 30, 2010.

InfuSystem Holdings, Inc. (OTCBB:INHI) (OTCBB: INHIW) (OTCBB: INHIU), the leading provider of infusion pumps and associated clinical services, today announced that it will present at the LifeTech Capital Medical Investors Conference. Sean McDevitt, Chairman and Chief Executive Officer and Pat LaVecchia, Vice Chairman, are scheduled to present on Friday, November 12, 2010, at 2:30 PM ET at the conference.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, today updated the progress of its drug development programs and reported financial results for the three and nine months ended September 30, 2010.

MMRGlobal, Inc. (OTCBB:MMRF) today announced that Sunil Singhal has been retained to oversee development of the Company's proprietary information technologies and help guide the process of ensuring that MMRGlobal continues to be a leader in innovation and efficiency in the health IT marketplace.

Novavax, Inc. (Nasdaq:NVAX) today announced financial results for the third quarter ended September 30, 2010.

Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) and Pain, announced today that it is the recipient of a $244,479 grant under the Qualifying Therapeutic Discovery Project (QTPD) Program.

PDL BioPharma, Inc. (PDL) (Nasdaq:PDLI) announced today that it has completed the exchange of $92.0 million in aggregate principal of the Company's outstanding 2.00% Convertible Senior Notes due February 15, 2012 in separate, privately negotiated exchange transactions with the note holders.

Regenicin, Inc. (OTC Bulletin Board:WDST) a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs, today announced that their November 4th investor presentation is available for archive viewing.

Sun Healthcare Group, Inc. (NASDAQ: SUNH) today announced that on Nov. 4, 2010, stockholders approved Sun's previously announced plan to restructure its business by separating its operating assets and its real estate assets into two separate publicly-traded companies

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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