FDA warns of thigh fractures with bone drugs. Transition Therapeutics drops diabetes drug. Print E-mail
By Mary Davila   
Wednesday, 13 October 2010 19:26

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 13, 2010.

U.S. health officials warned Osteoporosis drugs used to prevent bones from breaking in women, may increase the chances for an unusual type of thigh fracture. The drugs known as bisphosphonates include Merck & Co Inc's (NYSE:MRK) Fosamax, Roche Holding AG's (OTC:RHHBY) Boniva, Novartis AG's (NYSE:NVS) Reclast and Warner Chilcott Plc's (NASDAQ:WCRX) Actonel.

The action could drive patients to the just-launched rival medicine, Prolia, a different type of osteoporosis drug that is Amgen Inc's (NASDAQ:WCRX) most important future growth driver.

FDA officials said all bisphosphonates used for osteoporosis will carry a new warning about rare but serious fractures of the thigh bone, even though it remains unclear if the medicines caused the fractures.  The agency advised doctors to consider if patients on therapy for more than five years still need the drugs.


Transition Therapeutics Inc (NASDAQ:TTHI) has made the decision to abandon development of its lead diabetes compound the type-2 diabetes drug, TT-223, after it failed efficacy tests, sending its shares down 25 percent. TT-223 was being developed both as a combination treatment along with Eli Lilly & Co.'s (NYSE:LLY) diabetes therapy, as well as a standalone treatment.

The drug, a hormone that regulates secretion of digestive acids in the stomach, based on gastrin, failed to show efficacy when tested in combination with Eli Lilly's diabetes therapy in about 150 patients.

Here are other companies that made news on Wednesday:

The Amergence Group (PINKSHEETS:AMNG), a company that focuses on developing, nurturing, and rapidly expanding selected emerging or disruptive companies across a wide range of industries and disciplines, announced today that its subsidiary, Altitude Organic™ Licensing Corporation, has secured a strategic alliance with US-based manufacturer Hydrobotanical Engineering (www.Hydrobotanical.com), a leading manufacturer of hydroponic, aquaponic, and aeroponic portable automated growing environments featuring secure, managed, turnkey growing solutions for the medical marijuana industry.

Access Plans, Inc. (OTCBB: APNC), a leading membership benefits marketing company, today announced the appointment of Charles Harris as President of America's Health Care/Rx Plan Agency, Inc. ("AHCP"), the Company's insurance marketing division and subsidiary.

Akorn, Inc. (Nasdaq:AKRX)
will host a conference call on Tuesday, November 2, 2010, to discuss third quarter 2010 results followed by a Q&A session.

Allscripts (Nasdaq:MDRX) announced today that it will report its financial results for the three and nine months ended September 30, 2010 after the New York Stock Exchange closes on Monday, November 8, 2010.

The Amergence Group (PINKSHEETS: AMNG), a company that focuses on developing, nurturing, and rapidly expanding selected emerging or disruptive companies across a wide range of industries and disciplines, continues to report progress made by its strategic partner, Altitude Organic Licensing, who has now entered into a critical strategic alliance with MJ Freeway point-of-sale, inventory control, and patient management software(www.MJFreeway.com).

Applied DNA Sciences (OTCBB: APDN) announced that under the terms of a five-year agreement with an exclusive European luxury brand, APDN would receive a minimum of $8.7 million for supplying the Company with proprietary botanical DNA Authentication codes custom-made for the brand-owner's customers, in order to maintain exclusivity on the agreement in the specified field.

Bio-Rad Laboratories, Inc. (NYSE:BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostics products, and Axis-Shield plc (LSE: ASD) (OSE: ASD), an international and innovative in vitro diagnostics (IVD) company, today announced the U.S. Food and Drug Administration (FDA) clearance and U.S. launch of Bio-Rad's BioPlex® 2200 Anti-CCP test for the early detection of rheumatoid arthritis.

Cardium Therapeutics (NYSE Amex:CXM) today reported on new preclinical research findings that Excellagen, a topically applied formulated collagen wound management gel product candidate, activates platelet release of platelet-derived growth factor (PDGF) locally at the wound site.

Celgene Corporation (NASDAQ: CELG) and Abraxis Bioscience, Inc. (NASDAQ: ABII) today announced that Abraxis’ shareholders approved the merger agreement between the companies.

CEL-SCI Corporation (NYSE AMEX: CVM)
announced today it has received approval from the first Taiwanese Institutional Review Board ("IRB") to begin enrollment of subjects for a Phase III clinical trial of Multikine®, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.

Celsius Holdings, Inc. (NASDAQ: CELH) announced today the company has signed Europa Sports to deliver Celsius to health and fitness facilities throughout the country.

Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has entered into an exclusive, long-term marketing and distribution agreement with Transposagen Biopharmaceuticals, Inc., a Lexington, Kentucky-based provider of unique genetically modified rat models.

China Ruitai International Holdings Co., Ltd. ("China Ruitai" or the "Company") (OTC Bulletin Board CRUI), a manufacturer and distributor of cellulose ether additives for use in the production of pharmaceuticals, construction materials and adhesives, foods and beverages and cosmetics, announced that it secured a 50 ton cellulose ether contract valued at $0.5 million from ThinFilm, a Shanghai-based pharmaceutical tablet and pill coating company.

Cleveland BioLabs, Inc. (NASDAQ:CBLI) today announced that the Company has filed a registration statement with the Securities and Exchange commission for the unregistered shares underlying its Series B Class of Warrants that were issued in a private placement in 2007.

Cytori Therapeutics (NASDAQ: CYTX) closed its public offering of 4,000,000 shares of its common stock, plus 600,000 shares sold pursuant to the full exercise of an over allotment option previously granted to the underwriter, for a total offering of 4,600,000 shares of common stock.

Dyadic International, Inc. ("Dyadic") (Pink Sheets:DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products and solutions for the bioenergy, industrial enzyme and biopharmaceutical industries, announced today that it has been issued U.S. Patent No. 7,794,962 by the United States Patent and Trademark Office ("USPTO").

eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families, and small businesses, announced today that the company plans to release third quarter 2010 financial results on October 26, 2010.

Elan Corporation, plc (NYSE: ELN) announced today that it will host a conference call on Wednesday, October 27, 2010 at 8:30 a.m. Eastern Time (ET), 1:30 p.m. British Summer Time (BST) with the investment community to discuss Elan’s third quarter 2010 financial results, which will be released before the European and U.S. financial markets open.

Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for third quarter 2010 on Thursday November 4, 2010, after market close.

FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, today announced its financial results for the fiscal year ending June 30, 2010.

Healthcare Services Group, Inc. (NASDAQ:HCSG) reported that revenues for the three months ended September 30, 2010 increased over 9% to $195,114,000 compared to $178,829,000 for the same 2009 period. Net income for the three months ended September 30, 2010 increased approximately 12% to $9,169,000 or $.21 per basic and per diluted common share, compared to the 2009 third quarter net income of $8,225,000 or $.19 per basic and per diluted common share.

ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has developed an innovative method for manufacturing the company’s lead product candidate, ICT-107, a dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM).

Ligand Pharmaceuticals Incorporated (NASDAQ:LGND)
today announced that its partner Pfizer, Inc. (NYSE:PFE) launched Viviant® (Bazedoxifene) in Japan for the treatment of postmenopausal osteoporosis. Under the brand name Conbriza®, the drug is also marketed in Spain through a co-promotion with Almirall, an international pharmaceutical company based in Spain.

Luminex Corporation (Nasdaq:LMNX), today announced that it will host Planet xMAP Europe 2010, its annual European multiplexing technology symposium, October 20-21, 2010, at The Hofburg in Vienna, Austria.

The Medicines Company (NASDAQ: MDCO) has scheduled its quarterly conference call for Wednesday, October 27, 2010 at 8:30 a.m. Eastern Time to discuss third quarter 2010 financial results and operational developments.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that one of the world’s leading dermatology companies, Galderma, has standardized on the Medidata Rave®electronic data capture (EDC) and clinical data management (CDM) platform.

Merge Healthcare Incorporated (NASDAQ: MRGE), a leading health IT solutions provider, today announced that it was selected to provide perioperative solutions to St. Barnabas Medical Center a member of the six-hospital St. Barnabas Health System, which is the largest health system in New Jersey.

Osteotech, Inc. (Nasdaq:OSTE), a leader in the emerging field of biologic products for regenerative healing, announced today that it has received notification that the U.S. Department of Justice and Federal Trade Commission granted early termination of the Hart-Scott-Rodino waiting period for its proposed merger with Medtronic, Inc.  

Provista Life Sciences and Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today the validation study results of a blood test for early detection of lung cancer and Provista's plans to broadly introduce this new test to market.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces that its wholly owned subsidiary Shire Holdings Luxembourg S.a.r.l. acquired 99.21% of the shares of Movetis NV on October 12, 2010, following a successful tender offer launched in September 2010.

SIGA Technologies, Inc. (Nasdaq:SIGA) announced this morning that the U.S. Department of Health and Human Services (HHS) has announced HHS's intention to make an award to SIGA of a contract to deliver 1.7 million courses of its smallpox antiviral for the Strategic National Stockpile, pending resolution of issues relating to SIGA's status with the Small Business Administration.

SpectraScience, Inc. (OTCBB: SCIE), a San Diego based medical device company, today announced that Jim Hitchin, the Company's current Chairman and CEO, resigned as Chairman effective October 8, 2010 and that the Board elected Mark McWilliams to assume the duties of Chairman of the Board of Directors.

Spencer Pharmaceutical Inc. (PINKSHEETS:SPPH) provided its milestone objectives for the next 12 months.

Sunshine Biopharma, Inc. (OTCBB: SBFM) a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that it issued a letter to its shareholders advising that it had filed for patent protection worldwide and expects to enter Phase I clinical trials for its principal drug, Adva-27a, beginning with GMP manufacturing and animal tox studies.

TrovaGene, Inc. (Pink Sheets:TROV), a developer of transrenal molecular diagnostics to facilitate personalized medicine, received notice of U.S. Patent 7,803,929 entitled “Kits for diagnosis and monitoring of pathogenic infection by analysis of cell-free pathogenic nucleic acids in urine.”

True 2 Beauty Inc. (PINKSHEETS: TRTB) (the "Company"), a leading manufacturer and distributor of male sexual potency pills and liquid products in the United States, announced today the "Libigrow" family of products. www.libigrow.com has signed its first distribution agreement overseas.

The board of directors of Walgreen Co. (NYSE, NASDAQ: WAG) today authorized a new $1 billion share repurchase program, which will expire at the end of 2012.

XenoPort, Inc. (Nasdaq:XNPT) announced today that it will present data on a new preclinical product candidate, XP23829, at the upcoming 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Gothenburg, Sweden, October 13 - 16, 2010.

Ziegler (PINKSHEETS: ZGCO) kicked off its 13th annual Ziegler Senior Living Finance + Strategy Conference at The Hyatt Regency Resort & Spa in Bonita Springs, Florida on Wednesday, September 29, 2010.

 




"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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