Vasomedical rockets on FDA 510 k clearence. Radient announces another partnership, shares continue higher Print E-mail
By BioMedReports.com Staff   
Friday, 09 April 2010 19:48
Below is a list of the companies that made news in the healthcare sector on Friday, April 09, 2010.

Vasomedical, Inc. (OTC: VASO.OB), exploded to the upside today after the company, a leader in the non-invasive treatment and management of cardiovascular diseases, announced the receipt of the US FDA 510(k) clearance on April 2, 2010 to market its Vasomedical-BIOModel 2301 Combined ECG Holter and Ambulatory Blood Pressure Monitoring Recorder and Software Analysis System. Last year, the Vasomedical BIOX™ Model 1305 Holter Monitor and analysis software received FDA clearance.

Dr. Derek Enlander, an NYC Internal Medicine physician commented that "The Vasomedical BIOX 2301 is the only personal combined system to simultaneously and continuously record and store EKG and blood pressure data for 24 hours. The ability to view these parameters simultaneously, side by side is unique," Dr. Enlander went on to say, "it gives the physician more useful information to evaluate the patient's cardiovascular status and make appropriate clinical judgment."

Vasomedical, Inc. is primarily engaged in designing, manufacturing, marketing and supporting EECP(R) external counterpulsation systems based on the Company's proprietary technology. EECP(R) therapy is a non-invasive, outpatient therapy for the treatment of diseases of the cardiovascular system currently indicated for use in cases of angina, cardiogenic shock, acute myocardial infarction and congestive heart failure. The therapy serves to increase circulation in areas of the heart with less than adequate blood supply and may restore systemic vascular function. The Company provides hospitals, clinics and private practices with EECP(R) equipment, treatment guidance and a staff training and maintenance program designed to provide optimal patient outcomes.

The stock opened the day at 7 cents and erupted about mid-morning on the news. Shares, which traded as high as 44 cents, closed the day at 31 cents, up $.024, an incredible 342% on the day.

Radient Pharmaceuticals Corporation (AMEX:RPC) continued its recent run as the company, through its US-based subsidiary AMDL Diagnostics Inc., announced today it has extended its partnership with GenWay Biotech Inc., signing an exclusive 5-year marketing, sales and distribution agreement with GenWay Biotech Inc. for the commercialization of RPC's Onko-Sure™ in vitro diagnostic cancer (IVD) test in Russia and the former Soviet Republics.

Today's announcement marks the second Onko-Sure distribution agreement RPC signed this week and is a part of RPC's aggressive strategy to further commercialize Onko-Sure in key international markets with strong demand for cancer screening, diagnostic and monitoring tests. According to Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals, "I am extremely pleased with the most recent progress we've made in locking down distributors for Onko-Sure. GenWay is a key partner to RPC and we anticipate strong product sales through their extensive sales network in Russia and surrounding regions."

Radient was featured Wednesday, here on BioMedReports, as a breakout alert for subscribers while the stock was trading around 38 cents. The company was also featured on BioMedReports front page on Thursday, with an in-depth look at the company and an exclusive interview with Radient's CEO.

Shares were up another 76 cents today or a whopping 108%, closing the day at $1.47. Shares hit an intra-day high of $2.04 before pulling back. The stock continued its run in the after hours market, moving up to $1.59.

Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced the completion of a public offering of 4,025,000 shares of its common stock, including 525,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered by Ardea Biosciences. The net proceeds to Ardea Biosciences from the sale of shares in the offering, after deducting underwriting discounts and commissions, were approximately $77.1 million. Shares were up more than 3% on the day.

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for Pixuvri™ (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL"). The FDA cited as its primary reason for the action its concerns previously raised at the Oncologic Drugs Advisory Committee ("ODAC") meeting on March 22, 2010 and recommended the Company conduct an additional trial to demonstrate the safety and effectiveness of its product. Based on the FDA's ODAC presentation, which provided the Committee and the Company with alternative options to consider to make investigational drugs available to patients if drugs need to be studied further prior to approval, the Company has decided to pursue expanded access program for pixantrone while it conducts an additional study in aggressive NHL.

Cephalon, Inc. (Nasdaq:CEPH) announced that it has today completed its previously announced acquisition of Mepha, the Swiss-based pharmaceutical company. As a result of the acquisition, Mepha is now a wholly-owned subsidiary of Cephalon. The purchase price paid at closing, inclusive of certain closing adjustments, was CHF 662.4 million (or approximately US$615.4 million). The purchase price is also subject to further post-closing working capital and net debt adjustments.

Gentium S.p.A. (Nasdaq:GENT) continued its recent rally, moving up another 25% or $1.04, closing the day at $5.10 on no apparent news. The stock has been on the move since an abstract entitled: "Defibrotide prevents hepatic VOD and reduces significantly VOD-associated complications in children at high risk: final results of a prospective phase II/III multicenter study," was published in late March. The company has said that it intends to file for U.S. and European approvals of Defibrotide by the end of the second quarter of 2011.

Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that the company and its collaborators from Drexel University, Cheyney University, and the University of Pennsylvania have received a $2.8 million grant to develop a DNA vaccine to treat hepatitis C virus (HCV). The grant will fund pre-clinical studies to test the safety and effect on the immune system of Inovio’s novel vaccines designed to treat persons who are chronically infected with hepatitis C virus and have not responded to currently available therapies. Persons with chronic HCV infection face an increased risk of developing hepatocellular cancer, a difficult-to-treat cancer with a poor prognosis.

IRIDEX Corporation (Nasdaq:IRIX) today announced that it has acquired certain assets from RetinaLabs, Inc., a privately held company based in Atlanta, Georgia. RetinaLabs develops and markets innovative retinal instrumentation used by ophthalmologists to perform vitreoretinal procedures in the operating room and the surgery center. Pursuant to the terms of the purchase agreement, IRIDEX has acquired substantially all of the assets of RetinaLabs, including its existing product family together with certain additional intellectual property that IRIDEX anticipates incorporating into future products. The purchase price for the acquired assets consisted of $250,000 in cash consideration and 115,000 unregistered shares of IRIDEX common stock issued at closing, and an earn-out.

NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that it has expanded its San Diego facilities to accommodate an increase in demand for its pre-clinical research services. Bio-Quant now has approximately 28,000 sq. ft of modern, state-of-the-art laboratory, vivarium and office space.

Penwest Pharmaceuticals Co. (Nasdaq:PPCO) today announced that it has signed a drug development and commercialization agreement with Alvogen, Inc. under which Penwest and Alvogen have agreed to identify and select up to five compounds for generic development. Penwest's TIMERx technology may be used for each compound selected. Penwest will formulate the agreed-upon compounds and receive milestone and royalty payments that are linked to the development of each compound.

Alvogen, the U.S.-based pharmaceutical manufacturer of complex generic products for U.S., E.U. and other international markets, will be responsible for manufacturing, clinical trials and regulatory filings for each of the formulations, as well as commercialization of the products worldwide.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) rallied 15% today after BWS Financial raised their rating of the biotech stock from hold to buy. Shares moved up more than 15% or 58 cents, closing the day at $4.25.

XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that researchers from the Mayo Clinic will be presenting data on the use of XOMA's high-affinity antibody to interleukin-1 beta (IL-1 beta), XOMA 052, in myeloma at the 101st Annual Meeting of the American Association of Cancer Research (AACR). The poster, entitled "A novel humanized anti-IL-1beta antibody is highly effective at inhibiting IL-1 induced IL-6 production in myeloma patients in vitro" will be presented on Monday, April 19 at 2:00 PM Eastern.

Also Friday:

Covance Inc. (NYSE:CVD) is pleased to invite you to listen to its quarterly investor conference call that will be broadcast live over the Internet on Thursday, April 29, 2010 at 9:00 a.m. ET.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today presented data from a preclinical study evaluating the mechanism of action of a Toll-like Receptor (TLR) antagonist in a preclinical model of atherosclerosis.
Phase Forward Incorporated (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced today that it will release financial results for the quarter ended March 31, 2010 and hold a conference call with investors on Tuesday, April 27, 2010.
Reliv International, Inc. (NASDAQ:RELV) today announced that it will release financial results for the quarter ended March 31, 2010, and hold a conference call with investors on Thursday, April 29.
Walgreen Co. (NYSE: WAG)(NASDAQ: WAG) today announced that it has completed the acquisition of Duane Reade Holdings, Inc. The transaction includes all 258 Duane Reade stores in the New York City metropolitan area, as well as Duane Reade's corporate office and two distribution centers.
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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