Onyx jumps higher on new cancer study data. After the bell: Orexigen soars as FDA panel favors weight-loss drug Print E-mail
By BioMedReports.com Staff   
Tuesday, 07 December 2010 19:54

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 7, 2010.

After the bell shares of Orexigen® Therapeutics, Inc. (Nasdaq:OREX) nearly tripled after the company and its partner, Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502.to), announced that the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrate that the potential benefits of Contrave® outweigh the potential risks. The Committee also voted 11 to 8 that a dedicated study to examine the drug's effect on risk for major adverse cardiac events should be conducted as a post-approval requirement versus pre-approval.

If approved, Contrave would be the first weight loss drug approved in more than a decade. It was the third new weight-loss drug reviewed by regulators this year. The FDA rejected competing drugs from Vivus (Nasdaq:VVUS) and Arena Pharmaceuticals (Nasdaq:ARNA). Shares of those companies were given a boost on the news with Vivus rising 11% and Arena up 12% in extended trading.

The FDA is scheduled to make a final ruling on Contrave January 31st, 2011.

Shares were halted during Tuesday trading, ending the day at $4.87. In the after hours market shares of Orexigen exploded to the upside, gaining $7.53 or 154% to $12.42

Shares of Onyx Pharmaceuticals, Inc. (Nasdaq:ONXX) made a big move to the upside today after the company announced positive results from the Phase 2b 003-A1 study of single-agent carfilzomib, a next generation proteasome inhibitor, in patients with relapsed and refractory multiple myeloma.

The study focused on patients with multiple myeloma that has recurred or not responded to other therapy's. Multile myeloma is a cancer of the bone marrow and affects approximately 50,000 people in the U.S. The company reported a median overall survival of 15.5 months, saying that similar patients usually live for six to 10 months. Onyx said it plans to seek FDA approval sometime in 2011.

More than 4 million shares traded hands Tuesday, sending shares up $3.95 or 13.46% to $33.29.

CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, announced positive study results indicating that INNO-206, a tumor-targeting pro-drug formulation of the commonly prescribed chemotherapy agent doxorubicin, safely and effectively delivered doxorubicin at higher doses than conventional doxorubicin to human myeloma cancers grown in immune-deficient mice.

Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that an article describing 100% protection of non-human primates against a highly pathogenic monkeypox challenge after vaccination with its smallpox DNA vaccine has been published in The Journal of Infectious Diseases. Inovio’s DNA vaccine demonstrated strong antibody-based immune responses similar to that of the currently approved live viral vaccine (Dryvax®). The study conducted by Inovio scientists and their collaborators is described in this published paper, entitled, "Multivalent Smallpox DNA Vaccine Delivered by Intradermal Electroporation Drives Protective Immunity in Nonhuman Primates Against Lethal Monkeypox Challenge."Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA) announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration (FDA) in December to discuss the Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for AZ-004 (Staccato loxapine).

Also Tuesday:

Allied Healthcare International Inc. (NASDAQ: AHCI), a leading provider of flexible healthcare staffing services in the United Kingdom, today issued financial results for its fiscal 2010 fourth quarter and year-ended September 30, 2010.

BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that The Journal of Hand Surgery (JHS) has published in its December 2010 online edition pivotal CORD II phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum), a novel, first-in-class biologic, conducted by BioSpecifics' strategic partner Auxilium Pharmaceuticals Inc., for the nonsurgical treatment of adult Dupuytren's contracture patients with a palpable cord.

Caliper Life Sciences, Inc. (Nasdaq:CALP), a leading provider of tools and services for drug discovery and life sciences research, today announced that the company has received the remaining balance of the compound library for the Environmental Protection Agency's (EPA) Phase II ToxCast™ screening program.

CDEX Inc. (OTCBB:CEXI) a leading developer of chemical detection products, using patented technologies, for use in healthcare and security markets, announced the Company will exhibit its proprietary ValiMed G4 multi-component medication and narcotic detection system, at the 45th Annual Midyear ASHP Clinical Meeting and Exhibition.

China-Biotics, Inc. (Nasdaq:CHBT) the leading developer, manufacturer and distributor of probiotics products in China, today announced that a delegation from the Company's research and development department presented at the National Probiotics Research and Development, New Application and Equipment seminar in Hangzhou, China on November 21st.

China Biologic Products, Inc. (Nasdaq: CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, operating through its indirect majority-owned subsidiaries, Shandong Taibang Biological Products Co., Ltd. and Guiyang Dalin Biologic Technologies Co., Ltd., and its equity investment in Xi'an Huitian Blood Products Co., Ltd., today announced that it has received a plasma collection license from the Shandong Province Health Department for its newly built plasma collection station in Yishui county, Shandong province and will commence commercial plasma collection on December 9, 2010.

CONMED Corporation (NASDAQ: CNMD) announced today that HealthTrust Purchasing Group, LP (HealthTrust), a leading healthcare group purchasing organization, recently awarded three separate, multi-year purchasing agreements with two of CONMED's business units, Linvatec and Endoscopic Technologies.

Cytori Therapeutics (NASDAQ: CYTX) and Astellas Pharma Inc. have entered into a strategic equity agreement to evaluate the potential of adipose derived stem and regenerative cells for the treatment of serious illnesses for which there is no fundamental treatment.

ERT (Nasdaq:ERES) a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, today announced the appointment of Klaus Besier to the Company's Board of Directors.

First China Pharmaceutical Group, Inc. (OTCBB:FCPG), a rapidly growing pharmaceutical distribution company headquartered in Yunnan, China, is pleased to announce the signing of three new agreements for the distribution of its growing inventory of over 5,000 medicinal and pharmaceutical product lines to a number of hospitals located in areas that mark significant penetration into new regions of China.

Healthnostics, Inc., (PINKSHEETS: HNS), announced earnings guidance for its year ending December 31, 2010.

Insulet Corporation (NASDAQ: PODD)
today announced the sale of 3,000,000 shares of its common stock pursuant to an underwriting agreement with Canaccord Genuity Inc. acting as the sole bookrunner.

Luminex Corporation (Nasdaq:LMNX)
and One Lambda, Inc., the leading producer of transplant diagnostic products, have agreed to a long-term renewal of their 10-year strategic partnership aimed at developing platforms and technologies for human leukocyte antigen (HLA) typing and antibody screening for the organ transplantation market

Ophthalmic Imaging Systems (OIS) (OTCBB:OISI), a leading ophthalmic digital imaging and informatics company, announces that Chief Financial Officer Ariel Shenhar will present at the LD Micro Conference on Thursday, December 9, 2010 at 11:00 a.m. Pacific time.

Pegasystems Inc. (NASDAQ: PEGA), the leader in business process management (BPM) and a leading provider of customer relationship management (CRM) solutions, today launched a new solution that allows mortgage servicers to immediately increase quality, certainty and productivity in their foreclosure process.

Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) in partnership with Jaiva Technologies, today announced the formation of NuVax Therapeutics, Inc. -- a wholly owned subsidiary of Radient Pharmaceuticals.

Sangamo BioSciences, Inc. (Nasdaq:SGMO) announced today the presentation of preclinical data that demonstrate the ability to permanently correct a disease gene in an animal using systemic delivery of zinc finger nucleases (ZFNs).

Stellar Biotechnologies, Inc. (TSX-V: KLH) PINKSHEETS: SBOTF) is pleased to announce that it has acquired an exclusive, irrevocable, worldwide, sub-licensable and royalty-free license to the technology developed through a Collaborative Research Agreement between Stellar and Bayer Innovations (BIG).

UFood Restaurant Group, Inc. (OTCBB: UFFC) announced today that it is expanding its social media efforts and online presence to better engage with UFood Grill consumers and shareholders through Facebook, Twitter, YouTube and other social media applications.

Zurvita Holdings, Inc. (OTCBB: ZRVT) (OTCBB: ZRVTE)a dynamic direct-to-consumer network marketing company offering turn-key solutions for high-quality consumer and business products and services, today announced its financial results for the 2010 fiscal year ended July 31, 2010.




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