KV Pharma falls on FDA delay. Fibrocell gets PDUFA date. Strategic Diagnostics soars on FDA nod Print E-mail
By BioMedReports.com Staff   
Wednesday, 12 January 2011 19:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 12, 2011.

Shares of K-V Pharmaceutical Company (NYSE:KVa)were under pressure today after the company reported that the FDA has delayed its action date for Hologic, Inc.'s New Drug Application (NDA) for Gestiva, a treatment for the prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

An NDA was resubmitted in July 2010 by Hologic, and at that time the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of January 13, 2011. The action date has now been moved to April 13, 2011. The company remains confident in the approval of Gestiva and believes a positive action by the FDA is likely on or before the new PDUFA date.

In light of the situation, KV Pharma's CEO, Greg Davis said that the company is evaluating it's liquidity outlook and will provide an update when it completes that evaluation.

Hologic advised the Company that the FDA had recently requested additional information with respect to the Gestiva application. The requested information was provided to the FDA on January 10, 2011.

Shares of KV Pharma slumped 45 cents or 19.74%, closing Wednesday trading at $1.83.

Fibrocell Science, Inc. (OTCBB:FCSC.ob) announced today that the FDA has accepted for review the Company’s complete response submission for azficel-T, proposed brand name laViv, for the treatment of moderate to severe nasolabial folds and wrinkles. A Prescription Drug User Fee Act (PDUFA) date has been set for June 22, 2011.

"We are pleased that our complete response was accepted and look forward to working closely with the FDA through the review process," said David Pernock, Fibrocell Science Chairman and CEO. "If approved, azficel-T will be the first and only personalized cell-based aesthetic treatment."

Shares of Fibrocell rose 7 cents or 11.67% to 67 cents.

Strategic Diagnostics (NASDAQ:SDIX), got a boost today after the biotechnology company, developing tests for food pathogen detection, reported that the FDA has determined that the company's RapidChek SELECT Salmonella Enteritidis (SE) test system has shown to be equivalent in accuracy, precision and sensitivity to current standard methods for poultry use. For pooled egg testing, SDIX’s method is considered by FDA as equivalent to its standard test without a 96-hour hold period, thus delivering results with a substantial time and cost advantage.

Volume was more than 4 million as shares of SDIX soared 41.40% or 77 cents to $2.63.

NeoGenomics, Inc. (OTC Bulletin Board:NGNM.ob) announced today that it has completed a $3.0 million equity financing transaction. Five members of the Company's Board of Directors and senior management team and two existing institutional investors of the Company participated in the transaction. The transaction was priced at $1.50 per share and resulted in 2.0 million shares of new common stock being issued by the Company. No warrants were issued and no placement agent was used in the transaction. The Company plans to use the proceeds to strengthen its financial position and fund growth initiatives. NeoGenomics, Inc. is a high-complexity CLIA–certified clinical laboratory that specializes in cancer genetics diagnostic testing.

Shares of NeoGenomics surged 16 cents or 13.22% to $1.37

Merck (NYSE:MRK) and PAREXEL International Corporation (NASDAQ:PRXL), a leading global biopharmaceutical services provider, today announced that they have entered into an alliance by which PAREXEL will provide strategic access to global clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures, a division of Merck, is focused on the delivery of high quality biosimilars to the patients that need them.

Also Wednesday:

Codexis, Inc. (Nasdaq:CDXS) and DSM Pharmaceutical Products, the custom manufacturing organization of Royal DSM NV, today announce signing of an enzyme supply agreement.


Edwards Lifesciences Corporation (NYSE: EW) the global leader in the science of heart valves and hemodynamic monitoring, today announced the appointment of Aimee S. Weisner as corporate vice president, general counsel.Weisner will lead the company's legal organization and will report to Edwards' chairman and CEO, Michael A. Mussallem.

Hiru Corporation (PINK SHEETS: HIRU) subsidiary Jiangxi Shaungshi AHP announce that the company invested additional funds to expand company's R&D, and changed the name of its R&D from Jiangxi Shaungshi Research Institute has changed its name to Jiangxi Shaungshi Research Center.

Neogen Corporation (Nasdaq:NEOG) today announced that its rapid test for Salmonella enteritidis (SE) has been determined by the U.S. Food and Drug Administration (FDA) to be equivalent to the FDA's traditional testing method in accuracy, precision, and sensitivity for detecting SE.

NeoStem, Inc. (NYSE Amex:NBS) an international biopharmaceutical company with operations in the U.S. and China, today announced that Dr. Robin Smith, the Company's Chairman and CEO, will present on Wednesday, January 12, 2011 at the OneMedForum 2011 at 9:15 AM PST and at the Biotech Showcase™ 2011 at 11:00 AM PST. Both events will be held in San Francisco, California.

OmniComm Systems, Inc. (OTCBB:OMCM), a global provider of eClinical solutions and services, today announced that it received Safe Harbor Certification effective December 30, 2010.OmniComm complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework and meets the standards defined by the EU Directive on Data Protection.

Onstream Media Corporation (NASDAQ: ONSM), a leading online service provider of live and on-demand Internet broadcasting, corporate web communications and virtual marketplace technology, today announced MedicExchange has signed a MarketPlace365™ promoter agreement to develop a virtual marketplace and business community for the healthcare industry.

RESMED INC. (NYSE:RMD), announced today that on Thursday, January 27, 2011, it will release its results for the second quarter and six months of fiscal year 2011, ended December 31, 2010.

Sequenom (Nasdaq:SQNM) is very pleased to note the publication in the British Medical Journal (BMJ 2011;342:c7401) of a groundbreaking international study led by our longstanding collaborator, Professor Dennis Lo of The Chinese University of Hong Kong.

Vicor Technologies, Inc. (OTCBB: VCRT), today announced that Vicor has received notice that a manuscript detailing a study of the ability of its PD2i Analyzer™ to detect the presence of autonomic neuropathy in individuals with type 1 diabetes mellitus has been accepted for publication in Clinical Neurophysiology.Vicor Technologies is a biotechnology company focused on the development of innovative, non-invasive medical devices using its patented, proprietary PD2i® nonlinear algorithm and software.

 




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