Zogenix rises on migraine treatment approval. Orexigen moves higher before FDA panel. Merck buys into insulin space Print E-mail
By Mary Davila   
Thursday, 02 December 2010 19:50

Below is a look at some of the headlines for companies that made news in the healthcare sector on December 2, 2010.

Zogenix, Inc. (Nasdaq:ZGNX) and Desitin Pharmaceuticals GmbH today announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL DosePro(TM) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache. The drug, which is administered beneath the skin without a needle is needle-free version of the migraine treatment sumatriptan.

Shares rose 64 cents or 16% to $4.64.

Shares of Orexigen Therapeutics, Inc. (Nasdaq:OREX) jumped nearly 12% today as investors anticipate the up coming FDA advisory panel for the companys experimental weight loss drug, Contrave. Prior to the panel discussion on December 7th, the FDA will release a staff report tomorrow, December 3rd. The company has a January 31, 2011 PDUFA date.

Shares of Orexigen shot up 58 cents or 11.86% to $5.47. December call options also saw heavy action.

Merck & Co., Inc., (NYSE:MRK) made a move into the insulin space today. The company announced that they are acquiring privately held SmartCells, Inc. for $500 million. SmartCells is developing a glucose responsive insulin formulation for the treatment of diabetes mellitus. Said Nancy Thornberry, senior vice president and head, diabetes and obesity franchise, Merck Research Laboratories; "Through the acquisition of SmartCells we have obtained innovative technology that may enable us to develop glucose-responsive insulins. If this investigational technology is ultimately approved for use with patients, it could provide an important new therapy for the treatment of diabetes. This holds the potential to significantly impact the treatment of this disease."

Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin MINI-AMI, a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella® 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI). The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care. According to the American Heart Association (AHA), 400,000 patients in the U.S. suffer from STEMIs every year.

CEL-SCI Corporation (NYSE AMEX: CVM) announced today it has received governmental approval from the Taiwanese Department of Health to begin enrollment of subjects for a Phase III clinical trial of Multikine in Taiwan. Multikine is the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Taiwan is one of nine countries to participate in this global Phase III trial.

MedPro Safety Products, Inc. (OTCBB:MPSP.ob), a leading developer of transformational technologies that enable safer medication delivery and blood collection, announced today that its passive safety winged blood collection set, has received 510(k) market clearance from the U.S. Food and Drug Administration.

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that it has sued Teva Pharmaceutical Industries Ltd. in the United States District Court for the District of Massachusetts for infringement of two Momenta patents. The patents cover the company's innovative methods of producing enoxaparin sodium, which assure that the commercial product meets standards for identity and quality. One patent, U.S. Patent No. 7,790,466, is related to methods of processing enoxaparin to determine the presence of certain tetrasaccharide structures. The second patent, U.S. Patent No. 7,575,886, is related to methods of analyzing enoxaparin for the presence of a certain structural signature.

Sequenom, Inc. (Nasdaq:SQNM) today announced the pricing of an underwritten public offering of 14,000,000 shares of its common stock, offered at a price to the public of $6.00 per share. The gross proceeds to Sequenom from this offering are expected to be $84.0 million.

Also Thursday:

ALDA Pharmaceuticals Corp. (TSX VENTURE:APH) (OTCQB:APCSF) announces that new tests have shown that T36® Antiseptic Hand Sanitizer is completely effective against two types of new "superbugs" within 15 seconds.

Alexandria Real Estate Equities, Inc. (NYSE:ARE) today announced the completion and delivery of the first phase of the Alexandria Center™ for Life Science – New York City.

Amgen (Nasdaq:AMGN) today announced that it will present data from several key Nplate® (romiplostim) studies at the 52nd Annual Meeting and Exposition of the American Society of Hematology (ASH), Dec. 4-7, 2010, in Orlando, Fla.

Cardium Therapeutics (NYSE Amex:CXM) reported on a communication from the staff of the company's current listing exchange indicating that it considered the company to be noncompliant with one of the listing requirements of the NYSE Amex LLC, based on its quarterly report for the period ended September 30, 2010, and providing that the company should submit a plan that would reestablish compliance with the listing requirement by August 26, 2011.

First China Pharmaceutical Group, Inc. (OTCBB:FCPG) a rapidly growing pharmaceutical distribution company headquartered in Yunnan, China, wishes to announce the recent signing of agreements to distribute its full inventory of over 5,000medicinal and pharmaceutical product lines to two district hospitals in Yunnan Province, resulting in a total of ten new hospital agreements in less than 60 days, a significant increase in market share for the Company.

GeckoSystems Intl. Corp. (PINKSHEETS: GOSY) announced today that they have received a formal Request For Quote (RFQ) from FLAGMAN GRUPP LTD., in Tallinn, Estonia, for twenty (20) life support social robots (i.e. CareBots(tm)), training and spare parts.

InoLife Technologies, Inc. (OTCBB: INOL), a service based healthcare products development, integration and marketing Company announced today that it has hired Mr. David Klein as Vice President Of Business Development.

Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced today that it has entered into a business combination, effective immediately, with Transave, Inc., a privately-held, NJ-based biopharmaceutical company focused on the development of differentiated, innovative inhaled pharmaceuticals for the site-specific treatment of serious lung infections.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that multiple abstracts for KRX-0401 (perifosine) have been selected for poster presentation at the upcoming 52nd Annual Meeting of the American Society of Hematology (ASH), to be held in Orlando, Florida from December 4-7, 2010.

Medisafe 1 Technologies Corp. (OTCBB: MFTH), a developer of patented technologies that physically prevent unauthorized administration of prescription medications, announced today that that company has fully completed development of its locking syringe device.

MMRGlobal, Inc. (OTCBB: MMRF) (MMR) and Texas-based MMX Holdings, LLC, today announced integration of MMRPro into the MMX dashboard-based financial and operating management tool for ambulatory surgical centers (ASCs).

NewCardio, Inc., (OTC Bulletin Board:NWCI) a cardiovascular diagnostic solutions developer, announced today that Dr. Dorin Panescu, Chief Technical Officer and Vice President Research and Development, has been named an IEEE Fellow, effective January 1, 2011.

Oracle (NASDAQ: ORCL) News Facts: To provide the best patient care, the University of Chicago Medical Center is running its critical patient care applications on Oracle's Sun SPARC Enterprise M-Series Servers with Oracle Solaris.

Palatin Technologies, Inc. (NYSE Amex:PTN)
today reported it received notice from NYSE Amex LLC advising Palatin that it is not in compliance with certain conditions of the Exchange's continued listing standards under Section 1003 of the Exchange's Company Guide.

PROLOR Biotech, Inc., (NYSE Amex:PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that it has been added to two market indices established by the investment advisory firm MSCI--the MSCI Small Cap 1750 Index and the MSCI US Investable Market 2500 Index.

Proteonomix, Inc. (OTCBB: PROT) announced today that it has updated its corporate website to reflect the dynamic growth and investment opportunity that exists today.

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.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus