Emergent BioSolutions signs BARDA contract. Meridian receives FDA clearence for bacterium test Print E-mail
By BioMedReports.com Staff   
Tuesday, 13 July 2010 19:06
Below is a list of the companies that made news in the healthcare sector on Tuesday, July 13, 2010.

Emergent BioSolutions Inc. (NYSE:EBS) announced after the market closed on Tuesday, that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company’s large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

"In line with Emergent’s mission of protecting life, we are proud to be working with HHS to scale-up manufacturing of BioThrax, the only vaccine licensed by the Food and Drug Administration (FDA) for the prevention of anthrax infection," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "We applaud HHS for its unwavering commitment to strengthen the country’s biodefense infrastructure and to protect our military and civilian populations."

MAP Pharmaceuticals, Inc. (Nasdaq:MAPP) today announced results from a clinical trial comparing the pharmacokinetics (PK) and safety of LEVADEX™ orally inhaled migraine therapy with intravenous dihydroergotamine mesylate (DHE) in smokers and non-smokers. The trial was designed to measure whether systemic absorption and exposure in smokers is greater than in non-smokers. In the trial, the systemic absorption of LEVADEX was not higher and systemic exposure to DHE was not greater in smokers than in non-smokers. LEVADEX is a novel orally inhaled migraine therapy that has completed Phase 3 efficacy development for the acute treatment of migraine.

Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) Tuesday announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its new molecular amplification assay, illumigene™ C. difficile. Clostridium difficile is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon. The illumigene molecular amplification assay detects the presence of the toxin producing region from the C. difficile DNA, and provides highly accurate results in under an hour. Meridian, a leading manufacturer of rapid immunoassay C. difficile tests, expands its existing portfolio with this new, simpler molecular assay. As a result, the Company will be uniquely positioned in the market to provide a full line of testing solutions that will meet the needs of its domestic and international customers.

Pfizer Inc. (NYSE:PFE), together with its collaborator on the Alzheimer's Immunotherapy Program, Janssen Alzheimer Immunotherapy, presented new research this week at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 (ICAD 2010) from two podium and four poster presentations. This research indicates there may be potential for an increased risk of comorbid conditions, such as seizures, stroke and type 2 diabetes, with Alzheimer's disease (AD). These studies also provide new findings about the burden of care and costs associated with AD for patients and their caregivers.

"These findings underscore the importance of advancing research about the growing burden and costs of AD. We need to increase our understanding of the needs of patients and caregivers, as well as the economic costs of this disease," said Ronald Black, M.D., assistant vice president, Clinical R&D, on behalf of the Alzheimer's Immunotherapy Program. "The Alzheimer's Immunotherapy Program is committed to advancing such research as well as working to develop new therapies to help fight this devastating disease.

Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today that it has entered into a letter of intent (LOI) to acquire Provista Diagnostics Inc. (PDI), a Nevada corporation offering laboratory testing services that meet the Clinical Laboratory Improvement Act (CLIA) guidelines. Radient Pharmaceuticals intends to acquire PDI, in a stock-for-stock transaction, when respective due diligence for both companies is successfully completed. The rationale for the merger is that PDI has all rights, patents and trademarks for diagnostic technologies that Radient Pharmaceuticals believes will strengthen and complement its core business. Pursuant to the LOI, Provista will become a wholly-owned subsidiary of Radient Pharmaceuticals.

"The goal of this proposed merger is to build a more identifiable, broader and more profitable IVD testing business. The proposed merger represents a unique and high-value opportunity to expand CLIA testing services, test kit commercialization and research & development efforts for both RPC and PDI," said Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals.

Stereotaxis, Inc. (Nasdaq:STXS) rose more than 25% after the company announced Tuesday that its new capital order momentum continued to build in the second quarter of 2010. The Company generated new capital orders of $10.2 million, more than doubling new capital orders from the 2009 second quarter and representing a 42% sequential increase over orders in the first quarter of 2010. New orders from North America totaled $5.1 million of the total orders in the quarter.

"Our new capital order momentum in the quarter validates our view that driving clinical adoption builds both procedure revenue and market interest," said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis. "The largest increase was in North America where we have focused on clinical adoption. As a result, procedures in the U.S. are steadily increasing, resulting in higher utilization and stronger reference sites. In addition, we continue to generate a strong and balanced performance from Europe and the rest of the world."

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a recognized leader in RNAi-based therapeutic discovery and development, today announced that it was awarded an Advanced Technology Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

The grant will provide funding for pre-clinical development of RNAi therapeutics using RXi's novel, proprietary therapeutic platform, which includes both novel RNAi compounds and advanced delivery technologies.

Also Tuesday:

AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced the Company has entered into a multi-year supply agreement with a global medical device company.

Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it plans to issue its second-quarter 2010 financial results after the close of the market on Monday, August 9, 2010.

Baxter International Inc. (NYSE: BAX) today announced final E.U./U.S. post-authorization safety surveillance (PASS) data that support the safety and efficacy profile of ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] previously documented in prospective clinical trials in a new study published in the journal Haemophilia.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the world's leading dental laser company, today announced that it has eliminated 20 positions and has made additional cost-cutting measures across the organization, in order to better position the Company for future profitability.

Bristol-Myers Squibb Company (NYSE: BMY) will announce results for the second quarter of 2010 on Thursday, July 22, 2010. During a conference call at 10:30 a.m. EDT on July 22, company executives will review financial information and will address inquiries from investors and analysts.

Charles River Laboratories International, Inc.(NYSE: CRL) and WuXi PharmaTech (NYSE:WX) today announced that they have issued an updated inventor presentation in connection with Charles River's proposed acquisition of WuXi.

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST), a leading acute care therapeutics company, today announced that its Phase 2 safety study of CUBICIN® (daptomycin or injection) in the treatment of prosthetic joint infections caused by certain Gram positive pathogens met its study objectives.

Dehaier Medical Systems Ltd. (Nasdaq: DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced today that it has acquired an emergency ventilator product line (QS-100A series) from Beijing Qiumanshi Technology Co., Ltd.

Emergent BioSolutions Inc. (NYSE: EBS) announced today it will report financial results for second quarter 2010 on Thursday August 5, 2010, after market close.

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2010 financial results will be released on Tuesday, July 20, 2010, at 4:05 p.m. Eastern Time.

GLG Life Tech Corporation (TSX:GLG) (NASDAQ:GLGL) a vertically-integrated leader in the agricultural and commercial development of high quality stevia, announces the signing of a five-year agreement with Sugar Australia for the distribution and marketing of GLG's stevia extract products.

Human Genome Sciences, Inc. (Nasdaq:HGSI) and Lonza today announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE).

Johnson & Johnson (NYSE:JNJ) will host a conference call for financial analysts at 8:30 a.m. (Eastern Time) on Tuesday, July 20, 2010, to review second-quarter results.

K-V Pharmaceutical Company (NYSE: KVa/KVb) a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. (Nasdaq: HOLX) that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for Gestiva™ (hydroxyprogesterone caproate injection), 250 mg/mL.

PAREXEL International Corporation (Nasdaq: PRXL) will release Fourth Quarter and Fiscal Year 2010 financial results on Monday, August 9, 2010 after the close of the stock market.

PPD, Inc. (Nasdaq: PPDI) and Lovelace Biomedical and Environmental Research Institute (LBERI) today announced they have entered into a collaboration focused on future service opportunities for biopharmaceutical and government clients across a range of therapeutic areas.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Wayne J. Riley, M.D., M.B.A., joined its board of directors as an independent director.

Vyteris, Inc. (OTCBB: VYTR), manufacturer of the first FDA-approved active patch transdermal drug delivery system, and a leader in active transdermal drug delivery technology, today announced the appointment of four new members to its Scientific Advisory Board (SAB).

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.



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