FDA Unanimously Recommends Approval of Merck's VYTORIN; Endo Receives FDA Approval for Felodipine Extended-Release Tablets USP Print E-mail
By Staff and Wire Reports   
Wednesday, 02 November 2011 19:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 2, 2011.

Merck (NYSE: MRK) $34.21 +0.15 (0.44%), announced the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration unanimously voted to recommend approval of Merck's VYTORIN for use in patients with pre-dialysis chronic kidney disease.

The Committee's vote was mixed regarding whether there is sufficient evidence to support approval specifically for patients with end-stage renal disease who are receiving dialysis.

Merck is seeking indications for VYTORIN and for ZETIA in combination with simvastatin to reduce the risk of major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection trial. Neither product is currently indicated for this use.

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Endo Pharmaceuticals (NASDAQ:ENDP) announced the FDA has approved Felodipine Extended-release Tablets USP, 2.5mg, 5mg and 10mg.  Qualitest Pharmaceuticals, the generic business unit of Endo Pharmaceuticals, will manufacture and distribute the Felodipine Extended-release Tablets.

Felodipine Extended-release Tablets USP are the generic version of AstraZeneca's Plendil® Extended-release Tablets.

The total sales for Felodipine in the U.S. for the 12 months ended June 30, 2011 were approximately $84 million.

Endo Pharmaceuticals (ENDP +1.5%) gains after receiving FDA approval for its Felodipine.

 

Also Wednesday:

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Also Wednesday:



ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP),a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes,announced that it has entered into definitive agreements for the purchase of $5.2 million of units, consisting of Access common stock and warrants in a private placement financing with a select group of institutional and accredited investors.

Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), is pleased to announce the appointment of Jeff Riley, to serve as its independent, non-executive Chairman of the Board.

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the Center for Medicare and Medicaid Services (CMS) released the payment rates for the 2012 Current Procedural Terminology (CPT®) codes last night that will be used with XIAFLEX® for the treatment of adult Dupuytren's contracture patients with a palpable cord beginning January 1, 2012.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today reported quarterly revenues of $2.051 billion for the fourth fiscal quarter ended September 30, 2011, representing an increase of 9.5 percent from the prior-year period, or 4.0 percent on a foreign currency-neutral basis.

Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) filed an application for a new U.S. Patent that refines the use of fluorescent microscopy to increase the accuracy, sensitivity and specificity of the CyPath® diagnostic assay for lung cancer.

FONAR Corporation (NASDAQ: FONR), The Inventor of MR Scanning™, reported today the cessation of symptoms in a 41-year-old female patient with multiple sclerosis following noninvasive treatment.

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that two studies confirming the appropriate use of Bravo wireless pH monitoring for the assessment of gastroesophageal reflux disease (GERD) were presented at the American College of Gastroenterology meeting today.

Graymark Healthcare, Inc. (NASDAQ: GRMH), the nation's second largest provider of diagnostic sleep services and an innovator in comprehensive care for obstructive sleep apnea (OSA), has been invited to present at the Southwest IDEAS Investor Conference.

Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) today announced the U.S. Food and Drug Administration (FDA) has informed the company that the agency is not planning a panel review to render a decision on the Premarket Approval (PMA) application of the LuViva™ Advanced Cervical Scan.

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has priced an underwritten public offering of $430 million aggregate principal amount of Convertible Senior Notes due 2018, which was upsized from the previously announced $400 million offering. Citigroup is acting as the underwriter.

HWI Global®, (OTCBB: HWIC), the Pittsburgh-based clean room design builder, has been awarded the contract to provide specialized design and build construction services for the new KCC B2-Stem Cell Cellular Therapy Laboratory Renovations at Mt. Sinai Medical Center.

Mediware Information Systems, Inc. (NASDAQ: MEDW), a provider of comprehensive healthcare software solutions, today reported total revenue of $15.5 million for the first quarter of the 2012 fiscal year, which ended September 30, 2011.

MELA Sciences (NASDAQ: MELA) today announced that the U.S. Food and Drug Administration (FDA) has approved the pre-market approval (PMA) application for MelaFind®.

Myriad Genetics, Inc. (NASDAQ: MYGN) is proud to announce its receipt of the 2011 "Corporate Spirit of Giving Award" by the Utah Philanthropy Day Committee.  The award is given annually to a company that has made outstanding philanthropic and charitable service contributions to the community.

Commercialization experts from PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, will discuss how to maximize product value through launch and over the entire product lifecycle at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 14th Annual European Congress, to be held November 5 – 8, 2011 in Madrid, Spain.

ProPhase Labs (NASDAQ: PRPH) announced today that financial results for the third quarter, ended September 30, 2011, will be released before the market opens on Wednesday, November 9th.

Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM) and Cowen and Company announced that they acted as exclusive co-placement agents to its client Access Pharmaceuticals, Inc.(OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that it has entered into definitive agreements for the purchase of $5.2 million of units, consisting of Access common stock and warrants in a private placement financing with a select group of institutional and accredited investors.

Stellar Biotechnologies, Inc. (TSX-V: KLH) (PINKSHEETS: SBOTF) is pleased to announce they have retained A.B. Korelin & Associates Inc. of Blaine, WA to assist the Company in its preparation and submission of the Company's Form 20-F Registration Statement with the Securities & Exchange Commission ("SEC").



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