FDA priority review status sends pSivida shares higher Print E-mail
By BioMedReports.com Staff   
Tuesday, 31 August 2010 18:10

That and other companies that made news in the healthcare sector on Tuesday, August 31, 2010 are listed here.

PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and the environment, today after the market closed announced that it has agreed to sell its Illumination and Detection Solutions (IDS) business to Veritas Capital Fund III, L.P. a New York-based private equity firm, for approximately $500 million in cash ($482 million net of payment for acquired cash balances).

IDS includes approximately 3,000 employees and 14 manufacturing facilities worldwide and is a leading global provider of custom-designed specialty lighting and sensor components, subsystems and integrated solutions to major OEMs serving a number of applications within various health, environmental, and security segments. The business is expected to generate revenue of approximately $300 million in 2010.

Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions, announced today after the bell that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel’s RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

"Our customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthcare professionals with an additional format for pregnancy testing," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "RapidVue hCG is Quidel’s fourth product launch in the United States this year and is further confirmation of our success at reinvigorating our new product pipeline."

The 3-minute RapidVue hCG test is CLIA-waived for use with urine samples. Due to the assay’s dipstick format, RapidVue hCG requires no specimen manipulation in order to perform the test.

StemCells, Inc. (Nasdaq:STEM) announced today that its technology was recently used by independent researchers to achieve the first genetically engineered rat derived from rat embryonic stem (ES) cells. This breakthrough, published this month in the international peer-reviewed journal Nature, opens the door to the types of genetic manipulations previously only possible in mice, and paves the way for modeling a broader range of human diseases with the rat. Both mice and rats are used as animal models of human disease; however certain aspects of the rat's physiology, behavior, and metabolism are closer to the human, making rats the preferred species for drug development and studying human disease. The creation of this first rat model using rat ES cells validates intellectual property owned by StemCells, which includes the rights to patents covering both rat ES and rat induced pluripotent stem (iPS) cells as well as genetically engineered rats derived from these cells.

Earlier Tuesday:

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences (NASDAQ:ALIM) has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).

FDA Priority Review status is given to therapies that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This status reduces the review time goal from 10 months to six months.

Dr. Paul Ashton, President and CEO of pSivida said, "With priority review a response from the FDA regarding Iluvien could be received in the fourth quarter of this year. Approval of Iluvien would trigger a $25 million milestone payment to pSivida from Alimera. Under the license agreement pSivida is also to receive 20 percent of net profits on sales by Alimera."

After closing Monday's trading session at $3.26, Tuesday, shares of pSivida shot up as high as $3.75 before pulling back late in the day and closing at $3.43, up more than 5%.

Dynavax Technologies Corporation (NASDAQ:DVAX) announced today a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to take a systems biology approach to study the differences between individuals that do or do not respond to vaccination against the Hepatitis B virus. This study will be one of several projects covered in a five-year, $17.6 million grant to Dr. Jacques Banchereau of the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program.

EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that it will actively pursue its communication, education and marketing strategy by participating in select highly-regarded worldwide urology events.

Earlier this month, EDAP highlighted its technologies at the Asian Congress of Urology. In September, EDAP's sales and marketing team will participate in the 28th World Congress of Endourology and Shock Wave Lithotripsy (WCE & SWL), to be held in Chicago-Hotel Sheraton on September 1-3, 2010. Five abstracts will be presented specifically on the use of Ablatherm-HIFU as primary care and salvage for prostate cancer and the positive results achieved.

Halozyme Therapeutics, Inc. (Nasdaq:HALO) today announced the completion of its root cause investigation regarding HYLENEX manufacturing and has identified a corrective action plan and regulatory strategy to reintroduce HYLENEX to the market. Halozyme and Baxter are finalizing the materials for a meeting with the U.S. Food and Drug Administration to seek concurrence with the reintroduction strategy. During several meetings and discussions held between the two companies, Baxter's senior management has reiterated its commitment to the successful commercialization of HYLENEX. As a result of this progress, Halozyme has lifted the notice of breach that was delivered to Baxter Healthcare Corporation on May 16, 2010.

On May 17, 2010, Halozyme announced the voluntary withdrawal of affected lots of 150U HYLENEX product from distribution after Halozyme and Baxter confirmed the presence of particles in a limited number of vials of HYLENEX. This action was taken as a precautionary measure to ensure patient safety. Since then, the voluntary withdrawal has been proceeding as planned. To date, no adverse medical events have been reported in connection with noncompliant HYLENEX product.

Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today it has resumed collaborations with Mayo Collaborative Services, Inc. to conduct a clinical study for the validation of RPC's US FDA-approved Onko-Sure® in vitro diagnostic (IVD) cancer test as a useful tool in colorectal cancer (CRC) recurrence and treatment monitoring.

Also Tuesday:

A5 Laboratories Inc. (A5 Labs) (OTCBB:AFLB) today announced the CRO team headed by Dr. Matni has completed the validation of the first set of equipment that will be used for the testing of pharmaceutical raw materials and finished products.

Affymax, Inc. (Nasdaq:AFFY) today announced the company’s participation in the following investor conferences during the month of September.

Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN® (bimatoprost ophthalmic solution) 0.01% as a first-line therapy indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Biomerica, Inc. (OTCBB: BMRA), a global provider of advanced diagnostic products for the early detection of medical conditions, today reported net sales for the fiscal year 2010 were $5,075,222versus net sales of $4,934,771 in fiscal 2009.

China-Biotics, Inc. (Nasdaq:CHBT), a leading developer, manufacturer and distributor of probiotics products in China, today announced that the Company will host an Investor Day on Monday, September 20, 2010, in Shanghai. Members of China-Biotics' management team will present the Company's strategic goals, product developments, and key milestones.

D. Medical Industries Ltd. (NASDAQ:DMED) (TASE: DMDC) a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, today announced financial results for the three and six months ended June 30, 2010.

Ferro Corporation (NYSE: FOE), announced today the final results of its tender offer for all of its outstanding 6.50% Convertible Senior Notes due 2013, which expired at midnight, New York City time, on August 30, 2010.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that the company has signed a contract to begin the production of a prototype of its patented medicinal locking device technology.

Metiscan, Inc. (PINKSHEETS: MTIZ) is pleased to announce that the Company will be hosting a nationwide teleconference on Wednesday, September 1, 2010 at 4:15 PM (Eastern Daylight Time) and will discuss points of interest that affect Metiscan and its shareholders.

mPhase Technologies, Inc. (OTCBB: XDSL) announced today that scalable smart reserve cell technology is one of the itemsincluded in the Fiscal Year 2011 Defense Appropriations bill that was recently passed out of subcommittee in the United States House of Representatives.Scalable Smart Reserve Cell Technology is listed to receive funding in the amount of $2,500,000.

Niusule Biotech Corp. (OTCBB:NIUS)  a fast-growing, China-based bio-pharmaceutical company focusing on animal-health products and human nutraceutical supplements, today announced that it has signed a distribution agreement with China Nepstar Chain Drugstore Ltd, China's largest retail drugstore chain based on the number of directly operated stores.

Oncothyreon Inc. (Nasdaq:ONTY) today announced the appointment of Julie M. Eastland as Chief Financial Officer and Vice President, Corporate Development, effective September 7, 2010.

Orthofix International N.V. (NASDAQ: OFIX) announced today that it has established a new $300 million five-year credit facility, including a $200 million senior secured revolving line of credit and a $100 million senior secured term loan. JP Morgan Chase Bank, N.A. acted as Sole Bookrunner and Joint Lead Arranger along with RBS Citizens.

PacificHealth Laboratories, Inc. (OTCBB: PHLI), a nutrition technology company, today announced that Fred Duffner has been promoted to CEO and President reporting directly to the Board of Directors. Mr. Duffner had previously been named President in January 2010.

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) announced today that the Company will present preclinical findings for its humanized monoclonal antibodies that bind and neutralize the potentially life-threatening toxins produced by the bacterium, Clostridium difficile.

Salas Labs International, Inc. (PINKSHEETS:IPEX) is pleased to announce today the company has embarked on a new business model, a change of name from IPEX, Inc. to Salas Labs International, and new leadership.

Sanomedics International Holdings (Pink Sheets: SIMH), today announced that Gary O'Hara has been named Chief Technology Officer for Sanomedics International Holdings.

Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, today announced its support for inflammatory bowel disease (IBD) fellowships at leading medical institutions across the country.

Sirona (NASDAQ: SIRO), the dental technology leader, today announced that John Sweeney, Vice President of Investor Relations, will present at Baird's 2010 Health Care Conference on Tuesday, September 14th at the St. Regis Hotel in New York City.

Unity Management Group Inc. (PINKSHEETS:UYMG) is a Health Resource Company specializing in Physician and Hospital Practice Management, Medical Discount Plans, Business Services, Billing Software and Technologies.

USANA Health Sciences, Inc. (NASDAQ: USNA) today announced that its board of directors has authorized an additional $40 million for share repurchases of its outstanding common stock.

Versus Technology, Inc. (PINKSHEETS:VSTI) announced revenues of $1,797,000 for its third fiscal quarter ended July 31, 2010, a 55.5% increase compared to revenues of $1,155,000 for the same quarter of the prior year.

VIVALIS (NYSE Euronext: VLS), a biopharmaceutical company, today announced its consolidated accounts (IFRS) for the first half of 2010 ended June 30, as well as its strategic perspectives.

Yongye International, Inc. (Nasdaq:YONG) a leading manufacturer, developer and distributor of "Shengmingsu" brand plant and animal nutrient products in China, today announced that management will present at the Roth 2010 Hawaii Conference scheduled for September 1-6, 2010 at the Grand Wailea, Maui, Hawaii.

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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