Mylan wins temporary ban of Paxil, Panel asks FDA about secret J&J recall Print E-mail
By Mary Davila   
Tuesday, 21 September 2010 19:11
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 21, 2010.

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.


Mylan wins temporary ban of Apotex's generic Paxil - Mylan Inc (MYL.O) said it obtained a temporary order from a U.S. federal court, blocking Canada's Apotex Inc from selling a generic version of GlaxoSmithKline's (GSK.L) antidepressant Paxil. The order from a New Jersey court also prohibits Glaxo from supplying Apotex with a generic version of the product, Mylan said. Mylan had said it received patent licenses and the right to market generic versions of all three dosage strengths of the drug under a 2007 patent lawsuit settlement with Glaxo. The court has scheduled further hearings on Oct. 18, Mylan said. Mylan's shares, which have fallen 18 percent in the last six months, closed almost flat at $18.30 Tuesday on Nasdaq.

Panel asks if FDA knew about secret J&J recall - A U.S. House committee probing recent massive recalls of Johnson & Johnson (JNJ.N) consumer medicines wants to know if the U.S. Food and Drug Administration last year permitted the company to secretly recall potentially tainted stocks of its Motrin painkiller. The House Committee on Oversight and Government Reform on Tuesday said it had obtained an email in which an executive of J&J's McNeil consumer medicines unit described an agreement with the FDA authorizing J&J to conduct an unpublicized recall of adult Motrin.The committee said the agreement purportedly allowed McNeil to forgo a publicly announced formal recall of the Motrin product and to instead conduct a "soft market withdrawal."  The committee for months has been examining what it describes as the "phantom recall" of Motrin, in which contractors quietly bought up stocks of the painkiller from store shelves. The committee on Tuesday released a copy of a May 27, 2009, email from a McNeil executive to numerous colleagues, which cites a negotiated agreement with the FDA consenting to an unofficial recall of Motrin.

Also Tuesday:


Access Pharmaceuticals, Inc. (OTC Bulletin Board:ACCP), a biopharmaceutical company specializing in products for cancer and supportive care signed a $30 million supply agreement for MuGard with RHEI Pharmaceuticals, Inc. ("RHEI"), a specialty pharmaceutical company focused on bringing proprietary medicines to the China market.

Aethlon Medical, Inc. (OTC Bulletin Board:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, disclosed today that it has reestablished efforts to advance the Aethlon Hemopurifier® within U.S. Government programs that support the development and purchase of treatment countermeasures against bioterror threats.

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 Jefferies 2010 Global SpecPharma and European Healthcare Conference to be held October 5-6, 2010 at the Waldorf Hilton in London.

AmbiCom Holdings, Inc. (OTCBB: ABHI) today announced that it has signed a one million dollar credit facility accounts receivable financing facility with East West Bank, one of the largest independent commercial banks headquartered in California.

American Seniors Association Holding Group, Inc. (PINKSHEETS:AMSA) announced today it has entered into a Royalty Licensing Agreement with 60 Plus Association, Inc., based in Alexandria, VA.

Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH), today announced that it has entered into definitive agreements with certain accredited investors in connection with a private placement, or PIPE, financing transaction pursuant to Section 4(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.

Arch Biopartners Inc ("Arch" or the "Company")(CNSX:ARH) (OTC:FOIFF) announces it has formed a new American subsidiary, Colorado Cancer Therapeutics Inc ("CCT") with leading University of Colorado ("CU") chemists Dr. Lajos Gera and Dr. Robert Hodges.

AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, announced results of the Company's initial animal study conducted at a major university demonstrating the study group having a 95% less occurrence of arterial plaque compared to the control group.

Biogen Idec Inc. (NASDAQ: BIIB) announced today that its Hemophilia R&D Roundtable will be webcast live on Tuesday, September 28, 2010 at 1:00 p.m. EDT.

Bionovo, Inc. (Nasdaq: BNVI, BNVID), a drug discovery and development company focused on the unmet needs in women's health and oncology, today announced that Dr. Isaac Cohen, O.M.D., Chairman and Chief Executive Officer, will be presenting at the JMP Securities Healthcare Conference at 4:00 p.m. ET on Tuesday, September 28, 2010.

Boston Scientific Corporation (NYSE:BSX) today announced data from its PLATINUM QCA study, which is designed to evaluate the Company's PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent.

Cambridge Heart, Inc. (OTCBB: CAMH), a developer of noninvasive diagnostic tests for cardiac disease, today announced the launch of its Microvolt T-Wave Alternans (MTWA) technology as an integrated part of industry-leading cardiac stress test systems manufactured and distributed by Cardiac Science Corporation (Nasdaq: CSCX).

Celera Corporation (NASDAQ:CRA) today announced that the United States Patent and Trademark Office has issued United States Patent 7,799,530 relating to methods if determining heart attack risk by detecting the KIF6 gene variant and reduction of such increased risk by statin therapy.

China Medical Technologies, Inc. (the "Company") (Nasdaq:CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, today announced that it plans to offer, subject to market and other conditions, up to US$200 million aggregate principal amount of senior notes (the "Notes") with a maturity of five years in a private offering that is exempt from the registration requirements of the U.S. Securities Act of 1933, as amended (the "Securities Act").

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, will be presenting a corporate overview at the Fifth Annual JMP Securities Healthcare Conference on Monday, September 27, 2010 at the New York Palace Hotel, New York, NY. Clinical Data's presentation will take place at 10:00 a.m. EDT.

Coventry Health Care, Inc. (NYSE: CVH) announced today that it will release third quarter 2010 financial results on Friday, November 5, 2010.Allen Wise, Coventry's Chief Executive Officer, will be hosting a conference call at 8:30 a.m. ET on that day.

Cytta Corp's (OTCBB: CYCA) President, Gary Campbell, is pleased to announce that recent developments in the US healthcare system and managerially have allowed the Company to clearly delineate and greatly expand their business model of being an integration and solutions provider within the entire patient-centered medical home ecosystem.

Delcath Systems, Inc. (Nasdaq:DCTH) announced today that management will present at The Fifth Annual JMP Securities Healthcare Conference on Tuesday, September 28, 2010 at 11:30 a.m. ET in New York, NY.

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at the JMP Securities Healthcare Conference, which is being held Sept. 27-28, 2010, at theNew York Palace Hotel in New York.

HealthWarehouse.com, Inc. (OTC Bulletin Board:HEWA), a leading retail mail-order online pharmacy and Columbia Medical Associates, an outpatient clinic system offering medical services in the Spokane, Washington metropolitan area, announced a partnership to offer patients a 30-day supply of more than 300 generic prescription medications for $3.50 with free home delivery.

InfuSystem Holdings, Inc. (OTCBB:INHI) (OTCBB: INHIW) (OTCBB: INHIU), the leading provider of infusion pumps and associated clinical services, is pleased to announce today that it has filed a registration statement for an underwritten public offering of 2,789,203 shares of its common stock by certain wholly-owned subsidiaries of Kimberly-Clark Corporation.InfuSystem will not issue any new shares in the offering and will not receive any proceeds from the offering.

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the Phase I clinical study assessing Inovio’s PENNVAX™-B DNA vaccine delivered using its proprietary electroporation technology in a preventive setting has fully completed the enrollment of 48 healthy volunteers.

MMRGlobal, Inc. (OTCBB: MMRF) (www.mmrglobal.com), a leading provider of Personal Health Records (PHRs) and electronic document imaging and management systems for healthcare professionals, today announced that Robert H. Lorsch, the Company's Chairman and CEO, will be a featured speaker at the Health Technology Investment Forum (www.ihealthtran.com) taking place today at the Westin New York at Times Square.

Mylan Inc. (Nasdaq:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tacrolimus Capsules, 0.5 mg, 1 mg and 5 mg, the generic version of Astellas' Prograf® Capsules, a treatment to prevent rejection in people who have received certain organ transplants.

NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) today announced the closing of a public offering of 7,912,000 shares of its common stock, including 1,032,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters.

Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI.

OPTIMIZERx Corporation (OTCBB: OPRX) announces the following health systems and updates regarding its SampleMD virtual sample and support platform:
Emory Health System, the largest healthcare system in Georgia with 9,000 employees and more than 20 health centers, has signed an agreement to utilize SampleMD.

Oracle (NASDAQ: ORCL) Oracle today announced the launch of the Oracle Health Management Platform, a complete, open and integrated suite of unified solutions, combined with a framework on which providers and payors can build secure applications and services.

Oxford Resource Partners, LP (NYSE:OXF) ("Oxford") and Mendel Biotechnology, Inc. ("Mendel") today announced their collaborative agreement to develop a pilot project to produce Mendel's proprietary Miscanthus varieties on land previously reclaimed from mining operations by Oxford.

Polycom, Inc. (NASDAQ: PLCM), a global leader in telepresence, video and voice communications solutions, today expanded Polycom's leadership in voice over Wi-Fi (VoWi-Fi) products with next-generation Polycom® SpectraLink® 8400 series handsets for wireless voice and data applications that transform mobile unified communications (UC) in the workplace.

Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced the publication of a research article in Drug Development Research (71:351–357, 2010) on the neuroprotective effects of clavulanic acid, the active pharmaceutical ingredient of Serdaxin®, Rexahn’s lead CNS therapeutic currently in Phase II clinical trials.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will present at the Fifth Annual JMP Securities Healthcare Conference in New York, NY onTuesday, September 28 at 2:00 p.m. ET.

Shrink Nanotechnologies, Inc. ("Shrink") (OTCBB:INKN), an innovative nanotechnology company developing products and licensing opportunities in the alternative energy industry, medical diagnostics and sensors, and biotechnology research and development tools businesses, announced today that it has leased laboratory space (the "NanoShrink Lab") inside the TechPortal, an innovative and brand new technology facilitator center for commercial bioscience research companies which are in most cases based on University of California, Irvine research.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced today the addition of a new member to its board of directors. Effective immediately, Scott R. Ward has joined the SurModics board bringing the number of board members to nine.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today it has filed a complaint in the U.S. District Court for the Southern District of New York against Mylan asserting infringement of four patents related to the characterization of COPAXONE® (glatiramer acetate injection). The latest of these patents expires in February 2020.

Volcano Corporation (Nasdaq:VOLC) today announced the company's plans to launch Eagle Eye® Platinum, PrimeWire PRESTIGE™, and the s5™/s5i™ 3.2.1 Software at the Transcatheter Cardiovascular Therapeutics (TCT) Meeting from September 21 - 25 in Washington DC.  

Vycor Medical, Inc. (OTCBB: VYCO) (www.vycormedical.com), a medical device company that designs, develops and markets next generation neurosurgery retraction devices, today announced the appointment of a National Sales Director.

Walgreens (NYSE: WAG) (NASDAQ: WAG) will release its fiscal 2010 fourth quarter and year-end earnings results at 7:30 a.m. Eastern time Tuesday, Sept. 28, followed by a conference call with Walgreens management beginning at 8:30 a.m. Eastern time.



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