|Vertex Joins Merck in Winning FDA Panel Backing.|
|By BioMedReports.com Staff|
|Monday, 02 May 2011 20:19|
Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) experimental hepatitis C treatment won unanimous support from a U.S. panel which backed a similar drug from Merck & Co. (NYSE:MRK).
Outside advisers to the Food and Drug Administration said today, Telaprevir, Vertex’s drug, works to outweigh risks of skin rash and anemia, in an 18-0 vote. The FDA usually follows its advisory panels’ recommendations.
Vertex and Merck are vying to win the first FDA clearance in almost a decade for a medicine to treat the bloodborne liver disease. The companies are among about a dozen seeking to sell hepatitis C drugs with higher cure rates and fewer side effects than standard therapy.
Sales of telaprevir may surpass $2.1 billion in 2013, according to the average estimate of nine analysts surveyed by Bloomberg.
Standard treatments combine the antiviral drug ribavirin with peginterferon, an immune-boosting protein sold by Merck as PegIntron and Basel, Switzerland-based Roche Holding AG (PINK:RHHBY) as Pegasys. The FDA approved PegIntron in 2001 and Pegasys in 2002.
Vertex gained 46 cents to $56 at 7:12 p.m. EST in extended trading on the Nasdaq Stock Market. Trading was halted during today’s FDA panel meeting. Merck, the second-biggest U.S. drugmaker, gained 14 cents to $35.77 at 4 p.m. in New York Stock Exchange composite trading.
Both medicines are likely to win agency approval and may reach the market in May or June, said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in New York.
AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading skilled nursing and assisted living provider, has closed the previously announced acquisition of two skilled nursing facilities in Dublin and Marietta, Georgia, with the remaining third facility of this group located near Atlanta expected to close by end of May.
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today issued a statement about Friday's decision by the U.S. Court of Appeals for the District of Columbia on the legality of using federal funding for embryonic stem cell research.
Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced today that it will report first quarter 2011 financial results on Thursday, May 5, 2011, after the U.S. financial markets close.
Assisted Living Concepts, Inc. (NYSE: ALC) Highlights: Adjusted EBITDAR as a percent of revenues increased to 33.8%, up from 32.3% in the first quarter of 2010 --Increased average private pay occupancy by 2 and 29 units over the fourth quarter of 2010 and the first quarter of 2010, respectively --Increased private pay rates by 2.4% over the fourth quarter of 2010 --Board of Directors declared 2 for 1 stock split and post split dividend of 10 cents per share.
Caliper Life Sciences, Inc. (NASDAQ:CALP), today reported its financial results for the first quarter of 2011.
Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX) ("Connectyx"), www.connectyx.com, manufacturer and distributor of the MedFlash®, the nation's premier Personal Health and Wellness Management System (ePHM) for maintaining personal health records (PHR), released the following letter to shareholders from the management of Connectyx:
Cyberonics, Inc. (Nasdaq:CYBX), a global leader in epilepsy management, today announced the first implant of its AspireSR™ seizure response product on April 27, 2011.
Dendreon Corporation (Nasdaq:DNDN) today reported results for the first quarter ended March 31, 2011.
Divine Skin Inc. (OTC Bulletin Board:DSKX) announced an explosion in salon distribution of its DS Laboratories line for hair and skin.
Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzyme and protein products for the biopharmaceutical, biofuels and industrial enzyme industries, announced today that its research and development subsidiary, Dyadic Nederland B.V. ("Dyadic Netherlands"), has entered into a research agreement with Sanofi Pasteur, the vaccines division of sanofi-aventis Group, and EnGen Bio, Inc.
eResearchTechnology, Inc. (ERT), (Nasdaq:ERT) a global technology-driven provider of services and customizable medical devices to bio-pharmaceutical and healthcare organizations and the market leader for centralized cardiac safety and respiratory efficacy services in drug development, announced today that its Board of Directors has appointed Jeffrey S. Litwin, M.D. its new President and Chief Executive Officer and as a member of the board.
Generex Biotechnology Corporation (OTC: GNBT) today announced that Mark Fletcher, CEO, will present at RetailInvestorConferences.com.
Grupo Casa Saba (NYSE: SAB), Financial Highlights: (All figures are expressed in millions of current Mexican pesos. Comparisons are made with the same period of 2010, unless otherwise stated. Figures may vary due to rounding practices).
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), announced today that it has received positive Scientific Advice from the European Medicines Agency (EMA) for the development of Zerenex™ (ferric citrate) for the management and control of serum phosphorus in end-stage renal disease (ESRD) patients undergoing dialysis, and in pre-dialysis chronic kidney disease patients (CKD).
Marshall Edwards, Inc. (Nasdaq:MSHL), an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced today that it has entered into a definitive agreement with certain institutional investors to sell in a private placement common stock and warrants for gross proceeds of up to $4 million, before deducting fees and expenses of the offering, of which approximately $1.1 million would result from the sale of approximately 835,217 shares of common stock at $1.333 per share.
MELA Sciences, Inc. (NASDAQ: MELA), in recognition of Melanoma Monday® and Melanoma/Skin Cancer Detection and Prevention Month®, May 2011, today went live with Project Melanoma (http://www.projectmelanoma.com), a new website and social media initiative designed to give a voice to those who have been impacted by melanoma and to motivate others in a call-to-action to speak up and demand better, more widespread emphasis on safe sun behaviors, early melanoma detection, education, and awareness.
Misonix, Inc. (NASDAQ:MSON), a medical device company that designs, manufactures, and markets innovative, therapeutic, ultrasonic products worldwide for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications has announced their attendance at the American Physical Therapy Association's (APTA) Combined Sections Meeting (CSM), which was held in New Orleans, LA, February 10-12, 2011.
MMRGlobal, Inc. (OTCBB: MMRF) ("MMR") today announced that it is working with Alcatel-Lucent to integrate the MyMedicalRecords Personal Health Record with Alcatel-Lucent's TeleHealth Manager solution to simplify the collection and notification of vital health records.
OncoGenex Pharmaceuticals, Inc. (NASDAQ:OGXI) announced that the Company's first quarter 2011 financial results will be released on Monday, May 9, 2011 after the NASDAQ Global Market closes at 4:00 p.m. ET, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.
Oncothyreon Inc. (Nasdaq:ONTY) today announced that it will conduct a conference call to discuss its first quarter 2011 financial results and provide a review of its pipeline of products in development on Friday, May 6, 2011 at 1:30 p.m. Eastern time.
Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR) announced today that on April 29, 2011 the Compensation Committee of its Board of Directors approved the grant of inducement stock options to purchase an aggregate of 632,000 shares of common stock to 20 new employees.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, will announce first quarter ended March 31, 2011 financial results on Monday, May 9, 2011 before the markets open.
PAREXEL International Corporation (Nasdaq:PRXL) today announced its financial results for the third quarter ended March 31, 2011.
PharmAthene, Inc. (NYSE Amex: PIP) announced today that closing arguments in its breach of contract action against SIGA Technologies were held on Friday, April 29, 2011 in the Delaware Court of Chancery. Post trial briefs in the case were submitted by both parties to the Court in April 2011.
Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that results of a joint study with researchers at the University of Texas, M. D. Anderson Cancer Center show that Rosetta Genomics' miRview™ mets is a powerful tool to identify Tissue of Origin in Carcinoma of Unknown Primary (CUP) patients.
Sigma-Aldrich Corporation (NASDAQ:SIAL) will be presenting at the following investor conferences in May: Deutsche Bank 26th Annual Health Care Conference on Wednesday, May 4, 2011, at the Intercontinental Boston, Boston, MA, presenting at 10:00 AM (ET).
Sun Healthcare Group, Inc. (NASDAQ: SUNH) today issued the following comments in response to the proposed rule released last week by the Centers for Medicare and Medicaid Services (CMS) regarding fiscal 2012 reimbursement for skilled nursing facilities. In the proposal, CMS outlined two approaches to address the Medicare payment system; one that reduces Medicare payments by more than 11 percent, based on three months of data, and the second approach that provides for more time to evaluate the overall effectiveness of the new system.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced that it will release first quarter 2011 financial results before the market opens on Thursday, May 19, 2011.
Therapeutic Solutions International, Inc. (OTCQB: TSOI) (PINKSHEETS: TSOI), the only manufacturer of the chairside NTI Tension Suppression System that has helped countless patients prevent debilitating migraine and tension headache pain, announced today that James P. Boyd, D.D.S., Director of Research and Product Development at Therapeutic Solutions International ("TSI") will present at this year's "Dentaltown" meeting to be held May 4-7 in Las Vegas, Nevada.
TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for the treatment of cancer and other diseases, today announced that University of California, San Francisco (UCSF) Medical Center has purchased a TomoTherapy® TomoHD™ treatment system.
Verisante Technology, Inc.(TSX VENTURE:VRS)(PINK SHEETS:VRSEF) (the "Company" or "Verisante") announced today that the Canadian Institutes of Health Research ("CIHR") has approved a grant application by the BC Cancer Agency to develop the Verisante Aura™ skin cancer detection device based on matching funds from the Company.
VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the first quarter ended March 31, 2011.
Zynex, Inc. (OTCBB: ZYXI), a provider of pain management systems and electrotherapy products for medical patients with functional disability, announced today that it will host an investor webcast, Thursday, May 5, 2011 at 9:00 a.m. Mountain Time - 11:00 a.m. Eastern Time to discuss the Company's first quarter 2011 results.