EnteroMedics soars on FDA approval. Novo Nordisk takes stake in Aradigm Print E-mail
By BioMedReports.com Staff   
Monday, 02 August 2010 17:36

Below is a list of the companies that made news in the healthcare sector on Monday, August 02, 2010.

 

EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that the Company has received conditional approval for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration. The IDE outlines plans for conducting a pivotal trial, the ReCharge Trial, evaluating the safety and efficacy of VBLOC vagal blocking therapy delivered via the Company's second-generation Maestro RC System in the treatment of obesity. The Maestro System is the first obesity treatment to use neuroblocking technology and represents a less invasive alternative to existing surgical weight loss procedures, which alter digestive system anatomy, lifestyle and food choices and may present significant risks.

The Company also announced its plans to commercialize the Maestro RC System in Australia and expects to file an application for approval and listing with the Australian Therapeutic Goods Administration (TGA) upon receiving CE Mark certification for the Maestro RC System. EnteroMedics hopes to receive TGA approval during the second half of 2011. The Company continues to explore commercialization opportunities in other markets outside of the United States.

Shares of EnteroMedics gained more than 36% on the news, soaring 66 cents to $2.50.

Aradigm Corporation (OTCBB:ARDM) today announced that it has entered into a Stock Purchase Agreement providing for the issuance by the Company of 26 million shares of the Company’s common stock to Novo Nordisk A/S in a private placement as consideration for the termination of a promissory note in favor of Novo Nordisk under which approximately $9.1 million is currently outstanding, representing an effective price per share of $0.3505.

The promissory note represented a loan that was made by Novo Nordisk to the Company in 2006 in the principal amount of $7.5 million, with interest accruing at 5% per annum. The principal, along with the accrued interest, was payable in three equal payments of approximately $3.5 million in 2012, 2013 and 2014.

Igor Gonda, President and Chief Executive Officer of Aradigm stated, "Upon the closing of this transaction, we will have eliminated all debt from our balance sheet. We are appreciative of the support and cooperation we received from Novo Nordisk in executing this agreement."

Shares of Aradigm rose more than 22% on the news.


Cornerstone Therapeutics Inc. (Nasdaq:CRTX) a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that the Company has entered into a License Agreement and a Development Agreement with Alitair Pharmaceuticals, Inc, also known as The Cough Company. Under the terms of the agreement, Cornerstone has acquired a license to certain of The Cough Company's proprietary intellectual property and the companies will collaborate in developing one or more products to treat respiratory diseases.

Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today announced that it has exercised a restructured purchase option under its drug development financing collaboration with Symphony Icon Holdings LLC and acquired all the equity of Symphony Icon, Inc., thereby reacquiring all rights to LX1031, LX1032, LX1033 and the other drug programs subject to the collaboration.

Osteologix, Inc. (OTCBB: OLGX) through its wholly owned Irish subsidiary Osteologix Limited and the Servier Research Group, the leading French independent pharmaceutical company, today announced that Osteologix has granted Servier an exclusive royalty bearing license to develop and commercialize NB S101 (strontium malonate) to treat post menopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the U.S. NB S101 is an innovative molecule acting on both bone formation and bone resorption.

Positron Corporation (OTCBB:POSC), a molecular imaging and solutions company specializing in Nuclear Cardiology and a leader in Cardiac PET, announced today that the Company has significantly improved its balance sheet, financial strength and flexibility as a result of resolving several outstanding debts, including a settlement with certain investors relating to a prior financing transaction.

As a result of management efforts, Positron has effectively reduced its debt by over $6 million, from approximately $7 million at the end of the first quarter, and expects to be nearly debt-free within the upcoming weeks.

"Since the end of the first quarter the Company has worked diligently to take the necessary steps to make Positron financially stronger for the future. As a result, Positron has emerged from this process a stronger, more focused company with improved liquidity and manageable debt levels," said Patrick G. Rooney, Chairman and Chief Executive Officer of Positron. "With a stronger balance sheet we are eager to continue forward as a far more competitive enterprise – one that is well-positioned for strategic acquisitions and organic growth in the year ahead."

The Company noted that among the outstanding debts it was able to resolve, was a settlement with certain investors who had originally loaned Positron $1.3 million in May 2006, in the form of callable secured convertible notes. In settlement of the notes, plus interest, penalties and late fees, Positron paid the investors $1.0 million in cash and 8.5 million shares of common stock.

The Company also noted it will be filing a Form 8-K in association with today’s announcement.

Repligen Corporation (Nasdaq:RGEN) today announced that the Company has received three additional grants to support its research program to develop HDAC inhibitors for neurodegenerative diseases. Repligen has received $436,000 in research funding to support the ongoing development of histone deacetylase (HDAC) inhibitors for Friedreich's ataxia. The funding is comprised of $218,000 from the Friedreich's Ataxia Research Alliance (FARA) and $218,000 from Go Friedreich's Ataxia Research (GoFAR). The grants will support the synthesis and characterization of additional HDAC inhibitors in support of the development of a potential therapy for Friedreich's ataxia. Our continued collaboration with FARA and GoFAR provides access to a global network of scientific thought leaders and patients and partially funds the development of our Friedreich's ataxia program.

In addition, The National Institute of Neurological Disorders and Stroke (NINDS) has awarded a grant in the amount of $6.05 million over four years to The Scripps Research Institute and Repligen for the development of a novel HDAC inhibitor for Huntington's disease. Repligen is part of a collaborative network receiving the grant and has the potential to receive $2.9 million based on successful completion of various milestones during the four year program.

ULURU Inc. (NYSE Amex: ULU) announced today that Altrazeal Transforming Powder Dressing has been granted CE Mark Certification in all countries within the European Economic Area.

 

Also Monday:


ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatme ts for central nervous system disorders, today announced that it will report its unaudited financial results for the second quarter ended June 30, 2010 on Monday, August 9, 2010, after the U.S. financial markets close.

Allergan, Inc. (NYSE:AGN) today announced operating results for the quarter ended June 30, 2010.

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announc d that Murray Robinson, Ph.D., senior vice president, translational medicine, is scheduled to present at the Cancer Stem Cells & The Tumor Microenvironment Conference, part of IBC's Drug Discovery & Development Week, on Monday, August 2, 2010 at 1:45 p.m. (PDT) at the Hyatt Regency San Francisco Airport in San Francisco.

AVI BioPharma, Inc. (NASDAQ: AVII), a d veloper of RNA-based therapeutics, will report second quarter 2010 financial results after the NASDAQ Global Market closes on Monday, August 9, 2010.

BioElectronics (PINKSHEETS: BIEL) filed four applications for grants in order to conduct clinical studies on Diabetic Neuropathic Foot Ulcers, Oral Surgery Pain, Plantar Fasciitis, and Menstrual Pain.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has completed the Phase 1 clinical study of BMN 195, a small molecule utrophin up-regulator, for the treatment of Duchenne muscular dystrophy (DMD).

Bionovo, Inc. (Nasdaq:BNVI) today announced results from studies in neurons of its drug candidate Menerba for the treatment of menopausal hot flashes.

BMP Sunstone Corporation (Nasdaq:BJGP) today announced that the Company plans to release second quarter 2010 financial results on Monday, August 9, 2010, after the market closes.

Celsion Corporation (Nasdaq:CLSN), a biotechnology drug development company that is leveraging its heat sensitive liposomal technology platform to encapsulate and deliver high concentrations of proven chemotherapeutics, announces the appointment of Robert W. Hooper to its Board of Directors.

Charles River Laboratories International, Inc. (NYSE: CRL) today reported its results for the second quarter of 2010.

Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology markets, today announced that it will present a corporate overview at the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference at the Southampton Inn in Southampton, New York on Friday, August 13, 2010 at 9:20 a.m. Eastern Time.

drugstore.com, inc. (Nasdaq:DSCM), a leading online retailer of health, beauty, vision and pharmacy products, today announced the completion of the sale of the assets of its DS Pharmacy, Inc. subsidiary to BioScrip Pharmacy Services, Inc., a subsidiary of BioScrip, Inc., for approximately $10.5 million, which closed on July 30, 2010.

Enzo Biochem Inc.'s (NYSE: ENZ) wholly-owned subsidiary, Enzo Clinical Labs, Inc., and Empire BlueCross BlueShield, the largest health insurer in New York State, today jointly announced that effective August 1, 2010 Enzo Clinical Labs will be a participating laboratory in the Empire provider network for the metropolitan New York area.

Gen-Probe Incorporated (Nasdaq:GPRO) announced today that the Company will present at the Leerink Swann Life Science Tools and Diagnostics Roundtable Conference on Thursday, August 5, 2010 at approximately 12:50 p.m. Eastern time.

Dr. Robert McNally, of  GeoVax Labs, Inc. (OTC Bulletin Board:GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, has been named to the "PharmaVoice 100" for 2010 by readers of PharmaVoice magazine.

HealthWarehouse.com, Inc. (OTC Bulletin Board:HEWAD), a leading retail mail-order pharmacy and Health Care Access Now, a nonprofit Ohio corporation established to improve access and delivery of healthcare for Greater Cincinnati's underserved populations, have partnered to provide an affordable prescription program allowing people in need the ability to purchase 300 medications for $3.50 with delivery to their home or apartment.  

HemaCare Corporation (OTCBB:HEMA) announced today profitable second quarter 2010 results with a 4% increase in revenue over the first quarter of the year, and $224,000 of net income, a significant improvement over the first quarter loss of $204,000.

Hospira, Inc. (NYSE:HSP), a global specialty pharmaceutical and medication delivery company, today announced that the company will present at the Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference on Thursday, Aug. 12, 2010, in Southampton. N.Y.

IDenta Corp. (PINKSHEETS: IDTA) CEO Yaacov Shoham today issued the following additional statement concerning US retail marketing.

Idera Pharmaceuticals (Nasdaq: IDRA) today announced that it has received commitments from certain institutional investors to purchase approximately $15 million of securities in a registered direct offering.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced it will issue its second quarter 2010 investor update after the U.S. financial markets close on Thursday, August 5, 2010.

Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) today announced that it will report its second quarter 2010 financial results on Tuesday, August 10, 2010.

King Pharmaceuticals, Inc. (NYSE: KG) reported today that the Company plans to announce financial results for the second quarter ended June 30, 2010 prior to the market open on Monday, August 9, 2010.

K-V Pharmaceutical Company (NYSE: KVa/KVb) announced today that the Company received notification from the New York Stock Exchange ("NYSE") on July 27, 2010 of non-compliance regarding the Company's quantitative continued listing standards.  

Life Technologies (NASDAQ:LIFE), a provider of innovative life science solutions, announced at the International Association of Food Protection annual meeting t e launch of the MicroSEQ® E. coli O157:H7 assay, designed to detect the deadly strain of Escherichia coli (E. coli), using the company's industry-leading real-time PCR technology.

MannKind Corporation (Nasdaq:MNKD) today reported financial results for the second quarter ended June 30, 2010.

Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development solutions, today announced that Vice President of Partnerships Graham unn has been honored by PharmaVOICE magazine as one of the 100 most inspiring people in the life sciences industry.

Medivation, Inc. (Nasdaq:MDVN) today announced that it will host a teleconference and webcast with management to discuss second quarter 2010 financial results and provide a general business update on August 9, 2010, at 4:30 p.m. Eastern Time.

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI), a biopharmaceutical company discovering and developing targeted therapeutic and imaging radiopharmaceuticals for use in oncology, today announced that the Company has received a sixth extension of its waiver agreement with its Bond holders, allowing debt restructuring discussions to progress.

MultiCell Technologies, Inc. (OTC Bulletin Board:MCET) announces it has submitted four separate grant applications under the U.S. government's Qualifying Therapeutic Discovery Project ("QTDP").  The QTDP was created by Congress as part of the Patient Protection and Affordable Care Act, and provides a tax credit or grant equal to eligible costs and expenses for tax years 2009 and 2010.

Naturally Advanced Technologies Inc. (NAT, OTC Bulletin Board: NADVF, TSXV: NAT) announced today that CRAiLAR  Organic fibers, the foundation for a truly sustainable yarn in the apparel industry, has been approved for the Global Organic Textile Standard (GOTS) Textile Auxiliary Agents, or chemical input, certification, being recognized as using only the cleanest and least toxic ingredients in their (wet) processing.  

Omnicare, Inc. (NYSE: OCR) announced today that Joel F. Gemunder, President and Chief Executive Officer, has informed the Board of Directors of his decision to retire, effective July 31, 2010. Mr. Gemunder will also retire as a director.

Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, reported financial results for the quarter ended June 30, 2010.

Osteologix, Inc. (OTCBB: OLGX) through its wholly owned Irish subsidiary Osteologix Limited and the Servier Research Group, the leading French independent pharmaceutical company, today announced that Osteologix has granted Servier an exclusive royalty bearing license to develop and commercialize NB S101 (strontium malonate) to treat post menopausal osteoporosis, other bone and joint disorders and dental indications worldwide, except in the U.S. NB S101 is an innovative molecule acting on both bone formation and bone resorption.

PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, is pleased to provide an update on the Company's successful international approach to commercializing its proprietary and patent pending stem cell technologies.

PURE Bioscience (NASDAQ: PURE) today announced that based on encouraging preclinical data it has granted two product-specific licenses to pharmaceutical development partner FTA Bioscience for development of a silver dihydrogen citrate (SDC)-based treatment for tinea unguium, also referred to as onychomycosis (nail fungus), as well as for tinea pedis (athlete's foot).

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN)  today announced that a research team from the Molecular Medicine Unit at UCL-Institute of Child Health in London reported preclinical findings that Thymosin beta 4 (Tβ4), is essential to healthy heart development and embryonic survival.

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter ended June 30, 2010.

Simcere Pharmaceutical Group (NYSE:SCR), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today announced that it will report its unaudited financial results for the second quarter ended June 30, 2010 on Thursday, August 12, 2010, before the market opens in the United States.

SuperGen, Inc. (NASDAQ:SUPG) today reported financial results for the second quarter and six months ended June 30, 2010.

Synovis Life Technologies, Inc. (Nasdaq: SYNO), a leading biomaterial and surgical products company, has named Jodi Brendel to the position of vice president of lobal sales and marketing for its Surgical group, unifying the activities of sales and marketing domestically and internationally.

Tengion Inc. (Nasdaq:TNGN) today announced that it has appointed A. Brian Davis to the position of Chief Financial Officer.  Mr. Davis comes to Tengion after 15 years with Neose Technologies, Inc., a biopharmaceutical company using enzymatic technologies to develop improved protein therapeutics.

ULURU Inc. (NYSE Amex: ULU) announced today that Altrazeal Transforming Powder Dressing has been granted CE Mark Certification in all countries within the European Economic Area ("EEA").

Valeant Pharmaceuticals International (NYSE:VRX) today announced second quarter financial results for 2010.

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:VNDA), a biopharmaceutical company focused on the development and commercialization of products for central nervous system disorders, today announced it will release results for the second quarter of 2010, on Thursday, August 5, 2010, before the market opens.

Vermillion, Inc. (Nasdaq:VRML), a molecular diagnostics company, will host a web cast and conference call to give a company update following issuance of Q2 financial results on Thursday, August 12, 2010.

VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the second quarter and six months ended June 30, 2010.

Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company and a leading provider of surgical solutions for the foot and ankle marke , today reported financial results for its second quarter ended June 30, 2010.

WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for its second quarter ending June 30, 2010.




"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
 

Newsletter