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FDA rejects Orexigen diet drug, shares plunge. Valeant Pharma buying PharmaSwiss. Parexel slumps on lowered outlook(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on February 1, 2011.Shares of Orexigen Therapeutics, Inc. (Nasdaq:OREX) fell sharply today after the company, along with its partner, Takeda Pharmaceutical Company Limited (TSE:4502.to) announced that a Complete Response Letter was received from the FDA for the company's experimental weight loss drug, Contrave. The FDA sited concerns with the cardiovascular safety profile for the drug, specifically stating; "before your application can be approved, you must conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with naltrexone/bupropion does not adversely affect the drug's benefit-risk profile." In response to the FDA letter, Michale Narachi, President an CEO of Orexigen said, "We are surprised and extremely disappointed with the Agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 Advisory Committee meeting. We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the Contrave application." 187 million shares traded hands as shares of Orexigen plunged $6.59 or 72.50% $2.50. Meanwhile, VIVUS (Nasdaq: VVUS)which is working on its on weight loss pill tanked 15.42% or $1.38 to $7.57, while Arena (Nasdaq:ARNA), which is developing a weight management drug, lorcaserin, bucked the trend and gained 10 cents or 6% to $1.68. Shares of Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX.to) moved higher today after the company announced that it will acquire PharmaSwiss, a privately-owned branded generics and over-the-counter pharmaceutical company based in Zug, Switzerland for euro 350 million or about $480 million U.S. PharmaSwiss has a broad product portfolio in seven therapeutic areas and operations in nineteen countries throughout Central and Eastern Europe, including Poland, Hungary, the Czech Republic and Serbia as well as operations in Greece and Israel. PharmaSwiss is also partnered with several large pharmaceutical and biotech companies offering regional expertise in such functions as regulatory, compliance, sales, marketing and distribution. Shares of Valeant gained $2.46 or 6.73% to $38.99. PAREXEL International Corporation (Nasdaq:PRXL) slumped nearly 10% today after the company lowered its 2011 forecast. The company said it is taking longer than expected to acquire new contracts from drugmakers. The company specifically pointed out delays in converting its partnerships with Bristol-Meyers Squibb and Merck into contracts. Shares lost $2.29 or nearly 10%, closing the day at $20.92. Antares Pharma, Inc. (NYSE Amex: AIS) today announced that the first patient has been dosed in a clinical study evaluating the VIBEX MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional. BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that it has initiated a pivotal Phase III trial for N-acetylgalactosamine 6-sulfatase (GALNS or BMN 110), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), also called Morquio A Syndrome. "In under two years, we have progressed the GALNS program from Clinical Trial Application to initiation of the Phase III trial. We have received FDA feedback and have finalized the design of the Phase 3 pivotal trial," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today announced that it recently met with the U.S. Food and Drug Administration to discuss the status of the company’s New Drug Application for Morphine Sulfate Oral Solution as well as other pending product applications. The FDA informed the company that it intends to conduct a Pre-approval Inspection of Lannett’s manufacturing facility as part of its review of the Morphine Sulfate NDA. The company said its manufacturing facilities were previously inspected by the FDA in January and February 2010, and it responded to the observations within seven days. The FDA conducted a follow-up inspection in September, resulting in zero observations at Lannett’s plants in Philadelphia and a total of two minor 483 observations at its pain management products facility in Wyoming. Arthur Bedrosian, president and chief executive officer of Lannett, said, "The FDA indicated to us that it will approve our Morphine Sulfate NDA and certain other pending product applications, subject to our manufacturing facility passing the PAI, which we expect to occur shortly." Shares gained 20 cents to $5.43. Nutra Pharma Corporation (OTC.BB:NPHC) a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced the Publication of a Review Article, "Cobra Venom: A Review of the Old Alternative to Opiate Analgesics," Published in the January Issue of the Journal Alternative Therapies in Health and Medicine. Omeros Corporation (Nasdaq:OMER) today announced that the European Medicines Agency has confirmed that OMS103HP is eligible to be submitted for marketing approval in the European Union through the EMA centralized procedure. OMS103HP is Omeros' lead product candidate currently in a Phase III clinical program evaluating the drug's safety and ability to improve postoperative joint function and reduce pain following anterior cruciate ligament (ACL) reconstruction surgery. Omeros continues to expect the release of Phase III results this quarter. Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that it has signed two new agreements for the development and validation of microRNA-based diagnostics for various indications related to its Gen 3 products. The Company's Gen 3 tests will focus on cardiovascular indications, neurodegenerative diseases, women's health and early detection of certain cancers, and are designed to leverage microRNA biomarkers extracted from body fluids. Also Tuesday: BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, is pleased to announce it has retained Scarsdale Equities LLC as its financial advisor to explore various strategic alternatives.BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser manufacturer and distributor, today announced that the Waterlase® iPlus™ System dual-wavelength all-tissue laser was very successfully received at the Yankee Dental Congress 36 held at the Boston Convention and Exhibition Center January 27-29.China Medicine Corporation (OTC Bulletin Board:CHME) a leading manufacturer, developer and distributor of Western pharmaceuticals, traditional Chinese medicines, and other health products in the People's Republic of China, today announced that the Company has received the manufacturing license from the Chinese Ministry of Agriculture for the Company's proprietary recombinant, Aflatoxin Detoxifizyme (rADTZ), which is used for removing a potential cancer causing agent, aflatoxins (AFT), from food and animal feed. Cord Blood America, Inc. (OTC Bulletin Board:CBAI) has announced that Cord Blood America's CEO and Co-Founder Matthew Schissler has been named chairman of the Biotech Committee for the Nevada Development Authority. ERT (Nasdaq:ERES), announced today that Keith Schneck, the Company's Chief Financial Officer, is scheduled to present at the UBS 21st Annual Global Healthcare Services Conference at 8:00 AM EST on February 7, 2011 in New York City.Grupo International, Inc.(PINKSHEETS: GRPI) has extended for sixty days, the proposed acquisition of 80% of Richard Y Lange S. A. De C.V. while it completes its due diligence process.Kensey Nash Corporation (Nasdaq:KNSY), a medical device company primarily focused on regenerative medicine for a wide range of medical procedures, today reported the results for its second quarter ended December 31, 2010. Mediware Information Systems, Inc. (NASDAQ: MEDW), a provider of comprehensive healthcare software solutions for blood, medication and performance management, reported total revenue of $13.2 million for the second quarter of the 2011 fiscal year, a $2.4 million or 22 percent increase over the $10.8 million reported in the comparable quarter in fiscal 2010.MiMedx Group, Inc. (OTC Bulletin Board:MDXG), an integrated developer, manufacturer and marketer of patent protected biomaterial-based products, announced today that they will be attending the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting, February 15 – 19, 2011. Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, announced today that the journal Alternative Therapies in Health and Medicine has published a Review Article on the use of cobra venom as a treatment for pain. PROTEONOMIX, INC., (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, is pleased to announce the Company has made an additional patent filing.Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that it has signed two new agreements for the development and validation of microRNA-based diagnostics for various indications related to its Gen 3 products.Techne Corporation's (Nasdaq:TECH) consolidated net earnings for the quarter ended December 31, 2010 increased 7.3% to $26.5 million or $0.71 per diluted share compared with $24.7 million or $0.66 per diluted share for the quarter ended December 31, 2009.Transdel Pharmaceuticals, Inc. (OTC Bulletin Board:TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced that the Company has been exploring strategic alternatives aimed at enhancing shareholder value with two investment banks, American MedTech Advisors and ESC Advisors, a division of KEMA Partners.UV Flu Technologies, Inc. (OTCBB:UVFT) is pleased to announce that the Company's athletic distributor, New England Sports Sales, a national distributor of hockey and related athletic equipment to college and professional hockey teams across the US and Canada, has been notified that they will be facilitating the shipment of ViraTech UV-400 air purifiers to the Hockey Canada practice and training facility in Calgary.Versus Technology, Inc. (PINKSHEETS: VSTI) today announces release of its Enterprise View Mobile (EVM) application for customers using the iPhone, iPod Touch and iPad. Available at no charge, Versus customers can download the Versus EVM app from iTunes beginning today.Boston-based Research 2.0 initiated coverage of Viral Genetics, Inc, (Pink Sheets:VRAL) and published their initial report today.Weikang Bio-Technology Group Co., Inc. (OTC Bulletin Board:WKBT), a leading developer, manufacturer and marketer of Traditional Chinese Medicine, Western prescription and OTC pharmaceuticals and other health and nutritional products in the People's Republic of China, today announced the completion of its private placement offering for aggregate gross proceeds of $5.0 million. Zurvita Holdings, Inc. (OTCBB: ZRVT), a dynamic direct-to-consumer network marketing company offering turn-key solutions for high-quality consumer and business products and services, today announced that it will host its "Freedom Crusade" National Conference at the Westin™ Galleria in Houston, Texas, from February 18th to February 20th, 2011. 2010 BioMed Reports All rights reserved. 2011 BioMed Reports All rights reserved. |