FDA Arthritis Advisory Committee Voted Unanimously for XIAFLEX(TM) Approval; $115.7 Million Obtained in Equity Raise; Total Revenues of $42.1 Million, up 29.3% Versus Q3 of 2008

See the rest of the story here.

Theflyonthewall.com is Wall Street's specialist in breaking equity news. Veteran traders build a proprietary feed of news that's faster and more relevant than any other source. Try us for free and discover for yourself.

Monday, November 2, 2009.

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.

Bristol-Myers Squibb (NYSE:BMY) announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir.

ICON plc, (NASDAQ:ICLR), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, announced it has signed an extension to its strategic agreement with Eli Lilly and Company (NYSE:LLY) to manage the company’s clinical data management outside the US.

Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL) announced executive management will participate in the Oppenheimer Healthcare Conference to be held November 3 - 4, 2009 at the Waldorf Astoria in New York City.

Arrayit Corporation (OTC:ARYC) is pleased to join the federal government in their efforts to help control health care costs by leveraging Arrayit's leading edge health care platform.

AEterna Zentaris Inc. (Nasdaq:AEZS), a global biopharmaceutical company focused on endocrine therapy and oncology, announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with platinum-resistant and taxane-pretreated ovarian cancer.

Perrigo Company (Nasdaq:PRGO) announced it has signed a definitive agreement to sell its Israel Consumer Products business along with the related production assets in Israel to Emilia Group, a subsidiary of O. Feller Holdings Ltd., for 205 million New Israeli Shekels (approximately $54 million).

Vanda Pharmaceuticals Inc., (Nasdaq:VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, announced financial and operational results for the third quarter ended September 30, 2009.

Kinetic Concepts, Inc. (NYSE:KCI) announced the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted final regulatory approval for KCI to market and sell its innovative V.A.C.® Therapy System in the country.

Cytori Therapeutics Inc. (NASDAQ:CYTX) will release and host a webcast to discuss its third quarter financial results on Monday, November 9, 2009 at 10:30 AM Eastern time.

GTx, Inc. (NASDAQ:GTXI) announced it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

AMRI (NASDAQ:AMRI) announced a third compound being developed under its license and research agreement with Bristol-Myers Squibb Company (NYSE:BMY) will proceed into preclinical development.

GTC Biotherapeutics, Inc. (NASDAQ:GTCB) announced LFB Biotechnologies, a wholly owned subsidiary of LFB S.A. (Laboratoire françaindu Fractionnement et des Biotechnologies S.A., Les Ulis, France) and a strategic shareholder in GTC, has exercised its option to purchase $12.8 million of additional convertible preferred stock under the terms described in the financing agreements approved by GTC shareholders in July 2009.

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) has amended its license agreement with Exelixis, Inc. (NASDAQ:EXEL) as a result of which Ligand is now entitled to receive royalties on net sales of future products from a mineralocorticoid receptor program and a one-time $75,000 payment for providing access to certain patent rights.

Gilead Sciences, Inc. (Nasdaq:GILD), in collaboration with GlaxoSmithKline (GSK), announced plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH).

Dendreon Corporation (Nasdaq:DNDN) announced it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE 4; (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA).Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced a contract award to support the FDA’s production rollout of the company’s WebSDM™ Release 3.0 software, including the Empirica™ Study Clinical Trials Signal Detection system.

iMedicor (OTC:VMCI) announced it has received a Scope of Work (SOW) order from its partner, Franklyn Ideas, LLC (Franklyn) on behalf of one of its major pharmaceutical clients.

Walgreens (NYSE:WAG), the nation’s largest drugstore chain with more than 70,000 health service providers, will host its first-ever Diabetes Wellness Events at more than 1,500 stores nationwide in November.

CVS Caremark (NYSE:CVS) announced it has extended its contract to provide retail pharmacy benefit services and all clinical services for the Blue Cross and Blue Shield Government-wide Service Benefit Plan, also known as the Federal Employee Program (FEP).

Herbalife Ltd. (NYSE:HLF) reported third quarter 2009 net sales of $600.2 million, a decrease of 0.3 percent compared to the same period of 2008, primarily reclecting the 780 basis point unfavorable impact from currency fluctuations.

Antares Pharma, Inc. (Amex:AIS) announced it will release its third quarter 2009 financial results after the market closes on Monday, November 9, 2009, and host a conference call shortly thereafter at 4:30 PM (Eastern Time) to discuss the results.

La Jolla Pharmaceutical Company (NASDAQ:LJPC) announced its Special Meeting of Stockholders, which was convened on October 30, 2009, was adjourned to November 6, 2009 at 11:00 a.m., local time, at 4225 Executive Square, Suite 495, La Jolla, California.

Auxilium Pharma (AUXL) is currently awaiting a decision from the U.S. Food and Drug Administration (FDA) on its key pipeline candidate, Xiaflex, which is under FDA review for the treatment of Dupuytren’s Contracture. In September, Auxilium received a major boost in the form of a favorable recommendation from the FDA’s Arthritis Advisory Committee for Xiaflex [...]

(AUXL) Auxilium Pharma Awaiting FDA Decision

Endo Pharmaceuticals (ENDP) signed an agreement with UK-based ProStrakan Group Plc to acquire exclusive rights to commercialize Fortesta in the U.S., where the product is currently under Food and Drug Administration (FDA) review. Fortesta is a 2% testosterone transdermal gel for testosterone replacement therapy in male hypogonadism. The product uses a metered dose delivery system [...]

(ENDP) Endo Pharmaceuticals Buys US Rights to Fortesta

Wipro Technologies, the IT services business of Wipro Ltd. (WIT) announced that it has entered into a five year agreement with BP Plc. (BP) to provide IT Applications Development and Maintenance services for BP’s Fuels Value Chain and Corporate businesses across the globe. Endo Pharmaceuticals (ENDP) signed an agreement with UK-based ProStrakan Group Plc to acquire exclusive rights to commercialize Fortesta in the U.S., where the product is currently under Food and Drug Administration (FDA) review. Siemens Energy, a division of Siemens AG (SI), acquired the majority holding in the Chinese metalworking company Yangtze Delta Manufacturing and the Chinese aluminum foundry GISAP (GIS Steel & Aluminium Products), both headquartered in Hangzhou. The Italian Federation of Newspaper Publishers recently filed an anti-trust complaint against Google Inc. (GOOG). This prompted the Italian Competition Authority to search Google’s Milan offices on Thursday, pursuant to a probe that was ini[More...]

Biotech stocks are the most volatile in the world. One-day jumps of 200% and overnight crashes of 90% are commonplace. The biggest culprit behind biotech volatility? The United States Food and Drug Administration, the FDA. Before ending up on pharmacy shelves, every new drug needs to pass through a series of regulatory hurdles dictated by the FDA. Without the FDA's blessing, a drug – no matter how great it may be – cannot make it to market. So an FDA approval can help propel the stock 30% or more. A rejection could send the stock tumbling as much as 90%. Because of this, biotech traders love taking a position ahead of FDA rulings... Which means next month is shaping up to be one of the most event-packed months for biotech traders. I've highlighted six major FDA decisions in the next month below: Date Company FDA Action Drug –[More...]

Schaeffer's Laura Houser takes a look at activity on the Street after the market close

(CCMI)(BVF)(HSP)(ELN)(NTY)(PRGO)(AUXL)(AMMD)(ARTC)(BMET)(CNMD)(DVA)(HWAY)

New Webcast Interview With Complete Care Medical, Inc. CCMI President and CEO JP Monteverde III Now Available at www.TheGreenBaron.com
Marketwire Wed 7:30am