|FDA backs cancer, warns of prostate cancer drug risks|
|By Mary Davila|
|Wednesday, 20 October 2010 20:06|
Cancer drug Herceptin, Roche Holding AG's (PINKSHEETS:RHHBY), has been approved, in combination with chemotherapy, as a treatment for patients with HER2-positive advanced stomach cancer, the company's Genentech unit said.
Herceptin, or trastuzumab, is already approved for use in the 25 percent or so of breast cancer patients whose tumors generate the HER-2 protein, which can fuel cancer growth.
The latest FDA approval is based on a pivotal trial which showed that people who received Herceptin plus chemotherapy lived longer compared to those who received chemotherapy alone.
FDA warns of prostate cancer drug risks. - New warnings are needed for hormone treatments for prostate cancer about a small increased risk of diabetes and heart problems including sudden death.
The medications include Abbott Laboratories Inc's (NYSE:ABT) Lupron, AstraZeneca Plc's (NYSE:AZN) Zoladex and Sanofi-Aventis SA's (NYSE:SNY) Eligard.
The drugs, known as gonadotropin-releasing hormone (GnRH) agonists, a hormone that helps fuel prostate cancer growth which is used to suppress the production of testosterone. The drugs are approved to relieve symptoms of advanced prostate cancer in a treatment known as androgen deprivation therapy.
The FDA said the risk of diabetes and heart disease in men treated with the drugs appeared to be low, but that patients should be regularly monitored for increased blood sugar or possible signs of heart damage.
Other GnRH drugs include Watson Pharmaceuticals Inc's (NYSE:WPI) Trelstar, Endo Pharmaceuticals Holdings Inc's (NASDAQ:ENDP) Vantas, and Pfizer Inc's (NYSE:PFE) Synarel. Several generic versions also are sold.
Here are other companies that made news on Wednesday:
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 submitted additional patent applications, covering its Cobalamin-mediated oral drug delivery technology formulations of many global top-100 injectable drugs, as a result of the growing interest surrounding the company's proprietary oral delivery technology.
Allied Healthcare International Inc. (NASDAQ:AHCI), a leading provider of flexible healthcare staffing services in the United Kingdom, announced today that Sandy Young, the Company's Chief Executive Officer, will be presenting at the Oppenheimer 21st Annual Healthcare Conference to be held on November 2-3, 2010 at the Waldorf=Astoria in New York City.
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced the presentation of data from the Company's Duchenne muscular dystrophy and influenza programs at the 6th Annual Meeting of the Oligonucleotide Therapeutics Society in Dana Point, Calif.
China Cord Blood Corporation ("CCBC" or "the Company") (NYSE:CO), the first and largest cord blood bank operator in China, today announced that the Company has filed an amendment to its Annual Report on Form 20-F/A, which included audited financial statements for the fiscal year ended March 31, 2010 with the U.S. Securities and Exchange Commission.
Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at Cancer Immunotherapy: A Long Awaited Reality conference taking place October 21, 2010 at the New York Academy of Medicine in New York City.
EnteroMedics Inc.(NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced updated clinical results, including weight loss, HbA1c and hypertension control data, from the Company's VBLOC-DM2 ENABLE, EMPOWER and VBLOC RF2 Studies of VBLOC(R) vagal blocking therapy delivered via the Maestro(R) System.
ERT (Nasdaq:ERES) announced today that it will release its results for the third quarter 2010 on Thursday, November 4, 2010, after the market closes.
FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning(TM), today announced that on October 14, 2010, the Company received a notice of non-compliance from The NASDAQ Stock Market LLC based upon the Company's non-compliance with the minimum stockholders' equity requirement of $2.5 million for continued listing on The NASDAQ Capital Market, as set forth in NASDAQ Marketplace Listing Rule 5550(b)(1)(the "Rule") (the "Stockholders' Equity Requirement").
GeckoSystems Intl. Corp. (PINKSHEETS:GCKO) announced today that they have improved the performance of their proprietary machine vision system, the CompoundedSensorArray™, while lowering its manufacturing costs.
Generex Biotechnology Corporation (Nasdaq: GNBT, www.generex.com) today announced that it will be attending the 13th Annual Canadian Diabetes Association (CDA) (www.diabetes.ca) / Canadian Society of Endocrinology and Metabolism (CSEM) (www.endo-metab.ca) Professional Conference and Annual Meetings in Edmonton, Alberta.
Healthnostics, Inc., (PINKSHEETS:HNSS), announced the development of its new fill-and-seal machine, MicroFill-2160, through its specialty medical products manufacturing division.
Nano Mask Inc. (PINKSHEETS: NANM), a materials technology development company focused on health and wellness related markets, has announced a joint sales partnership with Dynamic Preventive Technologies (DPT) of Heath, Texas whereby DPT will represent Nano Mask's product line.
PacificHealth Laboratories, Inc. (OTCBB:PHLI), a nutrition technology company, announced today sweeping changes that affect every facet of its business.
Quest Diagnostics Incorporated (NYSE:DGX), the world's leading provider of diagnostic testing, information and services, announced that its Board of Directors increased the company's share repurchase authorization by $250 million.
Simulated Environment Concepts (PINKSHEETS: SMEV), the manufacturer and developer of medical, aesthetic and wellness equipment, increases its global medical appeal with a successful tradeshow hosted by Salon Rééducca -- a show dedicated to Physical Therapy and Rehabilitation Practices.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories announced today that it expects to report record revenue growth for the 3rd quarter of 2010.
Verenium Corporation (Nasdaq:VRNM), a pioneer in the development and commercialization of high-performance enzyme solutions, today announced that Purifine® PLC, the Company's novel enzyme specifically developed for the edible oil industry, has received all necessary Chinese government authorizations for sale as a processing aid in the edible oil industry.
David H. Fater, CEO of Vicor Technologies, Inc. (OTCBB:VCRT), today announced that on October 12, 2010 the U.S. Patent Office issued United StatesPatent #7,811,992 to Vicor for the use of a molecule discovered using the Company's novel drug discovery platform.
ViroPharma Incorporated's (Nasdaq:VPHM) third quarter financial results for 2010 are expected to be released on Wednesday, October 27, 2010 before the open of the U.S. financial markets.