Orexigen falls on drug safety concerns. After the bell: HGSI slumps after FDA delay, Allergan higher on positive panel vote Print E-mail
By BioMedReports.com Staff   
Friday, 03 December 2010 19:24

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 3, 2010.

After the bell shares of Human Genome Sciences, Inc. (Nasdaq:HGSI) traded down after the company, along with its partner, GlaxoSmithKline PLC (NYSE: GSK) announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for BENLYSTA as a potential treatment for systemic lupus erythematosus (SLE). Origiannly schedule for December 9, 2010 the PDUFA has been extended another 3 months to March 10, 2011.

The FDA asked for more information after the advisory meeting in November. The companies reported that they have submitted the requested data.

In extended trading shares of HGSI fell $2.00 or 7.81% to $23.60.

Shares of Allergan, Inc. (NYSE:AGN) moved higher in extended trading Friday after the company announced that the U.S. Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the LAP-BAND System, Allergan’s gastric band, on the basis of a favorable benefit-risk profile for weight reduction in obese adults who have failed more conservative weight reduction alternatives and have a Body Mass Index (BMI) of at least 35 or a BMI ≥30 and at least one comorbid condition.

The device is currently implanted in about 100,000 people each year and usually helps those patients lose 50 pounds or more. Federal guidelines have limited the flexible stomach band to patients who are morbidly obese.

The FDA is scheduled to make a final decision on the device by January 31st, 2011.

After the bell shares were up $2.09 to $70.89.

Shares of Orexigen Therapeutics, Inc. (Nasdaq:OREX) fell to today after an FDA review sited safety concerns for the company's experimental weight-loss drug, Contrave. On December 7th an expert panel will vote the drugs safety and efficacy. Study's have shown that the drug helps patients lose weight but also exposed potential issues related to heart health.

Shares of Orexigen slumped 66 cents or 12% to close Friday trading at $4.81.

ACCESS PHARMACEUTICALS, INC. (OTC Bulletin Board: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced it has updated its lead product website with its first patient MuGard experience testimonial video and additional clinician feedback.

Amarin Corporation plc (Nasdaq:AMRN) today announced that it is scheduled to present at the Canaccord Genuity 5th Annual Cardiovascular, Diabetes & Obesity Conference on Tuesday, December 7, 2010 at 3:00pm PST.

Clarient, Inc. (Nasdaq:CLRT) announced today the extension of the current pending offer by Crane Merger Sub, Inc., an indirect wholly-owned subsidiary of General Electric Company ("General Electric") (NYSE:GE) to acquire all of the outstanding shares of capital stock of the Company.

CONMED Corporation (NASDAQ:CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the U.S. Food and Drug Administration has given marketing clearance for the Company's thermal energy based tissue fusion system for use in a wide range of surgical procedures.

Dendreon Corporation (Nasdaq:DNDN) today announced PROVENGE® (sipuleucel-T) data presentations taking place at the 52nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida and the Society of Urologic Oncology (SUO) Annual Meeting in Bethesda, Maryland.

First China Pharmaceutical Group, Inc. (OTCBB:FCPG) announced today that its company information will be made available via Standard & Poor's Market Access Program, an information distribution service that enables subscribing publicly traded companies to have their company information disseminated to users of Standard & Poor's Advisor Insight.

Gentiva Health Services, Inc. (Nasdaq:GTIV), the nation's largest provider of home health and hospice services, announced today that it has scheduled a conference call and webcast on Thursday, December 16, 2010, at 10:00 a.m. ET to provide an update on its 2011 outlook. Gentiva plans to issue a news release the morning of December 16 before pre-market trading.

Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced the appointment of Gregory I. Frost, Ph.D., to serve as president and CEO, effective immediately.

Hiru Corporation (PINKSHEETS:HIRU) subsidiary Shuangshi AHP Co. dispatched company representatives to evaluate the agricultural developments and increase company sales in the regions of Ganzhou, Yichun and Jian.

Insulet Corporation (NASDAQ: PODD), the leader in tubing-free insulin pump technology with its OmniPod® Insulin Management System, today announced the Company will participate in the Canaccord 5th Annual Cardiovascular, Diabetes and Obesity Conference at the Nikko Hotel in San Francisco.

Medical Marijuana Inc (PINKSHEETS:MJNA) announces that its division, The Hemp Network, has released its latest product "HEMP OMEGA" into the marketplace.

Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that, as anticipated, on November 30, 2010, the Company received a letter from the Listing Qualifications Staff of The NASDAQ Stock Market notifying the Company that, based on its failure to regain compliance with the $1.00 minimum bid price requirement, as set forth in NASDAQ Listing Rule 5550(a)(2), the Company's common stock would be subject to delisting from The NASDAQ Capital Market unless the Company requests a hearing before the NASDAQ Listing Qualifications Panel.

Nu Skin (NYSE:NUS) scientists presented research findings on how mental and physical vitality is improved through nutritional strategies that influence mitochondrial-related genetic expression.

PharmAthene, Inc. (NYSE Amex:PIP), the biodefense company developing medical countermeasures against biological and chemical threats, has been making headlines on Wall Street after filing a breach of contract lawsuit against SIGA Technologies Inc.

Sequenom, Inc. (Nasdaq:SQNM) today announced that the underwriters of its previously announced common stock offering that priced on December 2, 2010 have exercised in full an option to purchase an additional 2,100,000 shares of its common stock.

TeamStaff, Inc., (NASDAQ: TSTF), a leading logistics and healthcare services provider to the USGovernment including the Departments of Defense and Veterans Affairs, is pleased to announce the appointment of John F. Armstrong as executive vice president of corporate development for TeamStaff.

"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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