|NewCardio to unveil CardioBip. After the bell, jury rules against Teva|
|By BioMedReports.com Staff|
|Friday, 07 May 2010 21:06|
Below is a list of the companies that made news in the healthcare sector on Friday, May 07, 2010.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that a Las Vegas Jury awarded $356M in punitive damages against Teva Parenteral Medicines.
Teva is reviewing the full judgment and continues to believe that the evidence shows the Company acted responsibly. The label for its propofol product clearly states that it is for single patient use only and that aseptic procedures should be used at all times.
Teva believes that there are numerous grounds for appeal, and plans to contest the verdict vigorously.
Teva and Baxter Healthcare Services (NYSE:BAX) were ordered to pay a combined $500 million in punitive damages to a Nevada man who contracted Hepatitis C during an outbreak two years ago. The Nevada jury ordered Teva to pay $356 million and Baxter to pay $144 million. Teva manufactured the drug while Baxter was the distributor.
Henry Chanin and as many as 114 others contracted the liver disease Hepatitis C after the anesthetic propofol were reused for colonoscopy or endoscopy procedures.
In news from earlier in the day Friday:
NewCardio, Inc., (OTC Bulletin Board:NWCI.ob) announced Friday that the company will unveil its patented CardioBip technology for remote wireless 12-lead detection and monitoring of atrial fibrillation, ischemia and other cardiovascular events at the Heart Rhythm Society (HRS) 31st Annual Scientific Sessions, May 12-15, 2010, in Denver, Colorado.
NewCardio will give conference attendees the opportunity to learn about NewCardio's unique 3-D platform technology: CardioBip, a unique, hand-held device that provides an effective, solution for ECG remote monitoring; Cardio3KG, advanced software which provides quantitative analyses of cardiac electrical activity, with improved sensitivity and specificity over the standard 12-lead ECG for diagnosis of acute coronary events; and QTinno, a software solution that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety in drug development. In addition, NewCardio personnel will be on-hand to demonstrate the CardioBip, both at the Company's booth and on May 13th in a suite at the Hyatt Regency Denver, adjacent to the Denver Convention Ctr where HRS is held. Session attendees can utilize the CardioBip on themselves to see first-hand the simplicity and effectiveness of the technology.
HRS is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. The Annual Scientific Sessions attract more than 9,000 professionals representing the allied specialties of cardiac pacing and cardiac electrophysiology.
NewCardio's CEO, Branislav Vajdic, PhD., commented, "CardioBip is the first remote, wireless, non-invasive device which provides accurate 12-lead ECG results, and as such we believe it will propel remote cardiac monitoring to an entirely new level. This is the culmination of several years of work to advance this technology, and we are excited to share this significant clinical and technological advancement with scientists, medical professionals and industry leaders at the HRS Annual Scientific Sessions. With its 3-D technology, CardioBip will provide important data that addresses significant problems with the diagnosis and treatment of chronic cardiac conditions."
The CardioBip is a unique, hand-held device that provides a solution for ECG remote monitoring. Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device's electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms.
Adeona Pharmaceuticals, Inc., (AMEX:AEN) announced today that it has entered into a corporate partnership with Sweden-based Meda AB, to develop flupirtine for the treatment of fibromyalgia syndrome which contemplates the payment to Adeona of up to $17.5 million in upfront and milestone payments, plus royalties.
Under the terms of the agreement, Adeona has granted Meda an exclusive sublicense to all of Adeona's patents covering the use of flupirtine for fibromyalgia. These patents have issued in the US and are pending in Canada and Japan. Meda will assume all future development costs for the commercialization of flupirtine for fibromyalgia. Adeona received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon filing of a New Drug Application with the Food and Drug Administration for flupirtine for fibromyalgia and $10 million upon marketing approval. Adeona is also entitled to receive royalties of 7% of net sales of flupirtine approved for the treatment of fibromyalgia covered by issued patent claims in the Territory. Adeona will share such royalties equally with Adeona's university licensor.
Ardea Biosciences, Inc. (Nasdaq:RDEA) a biotechnology company focused on the development of small-molecule therapeutics for the treatment of gout, cancer and human immunodeficiency virus (HIV), today reported recent accomplishments and financial results for the first quarter ended March 31, 2010. "We are pleased to have accomplished a number of very important objectives since our last quarterly update," commented Barry D. Quart, PharmD, president and chief executive officer of Ardea. "In March, we announced positive, preliminary top-line results from our completed Phase 2b monotherapy study of RDEA594 and, shortly thereafter, we were able to significantly strengthen our financial position by completing a $77 million
public financing. These important achievements position us well for our next major objectives of obtaining regulatory approval of our Phase 3 plan, and initiating the Phase 3 development program for RDEA594."
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) today reported financial results for the first quarter ended March 31, 2010.
Arena reported a lower net loss in the first quarter of 2010 of $31.3 million, or $0.33 per share, compared to a net loss in the first quarter of 2009 of $50.6 million, or $0.68 per share.
"We believe that lorcaserin represents a significant medical and commercial opportunity based on the drug candidate's unique combination of safety, efficacy and tolerability in our pivotal trial program," stated Jack Lief, Arena's President and Chief Executive Officer. "We look forward to continued interaction with the FDA to complete its review of the lorcaserin NDA. If approved, lorcaserin has the potential to reenergize the weight management pharmacotherapy market and improve the treatment of obesity."
AVI BioPharma, Inc. (NASDAQ:AVII), a developer of RNA-based drugs, and its collaborators, including the National Institutes of Health, today announced the publication online in The Journal of Infectious Diseases of new data demonstrating the potential utility of phosphorodiamidate morpholino oligomers (PMOs) as antimicrobial agents."These studies provide continuing validation of the broad potential of our leading RNA-based technologies, including our PPMO and PMOplus chemistries, as anti-infective therapeutics," commented J. David Boyle II, Interim President and Chief Executive Officer of AVI BioPharma.
The first clinical trial of adipose (fat) tissue-derived stem and regenerative cells for the treatment of heart attacks showed a substantial reduction in the size of injury to the heart, an improvement in the amount of blood supply to the heart muscle, and a corresponding functional improvement in the amount of blood the heart can pump. Based on positive safety and feasibility outcomes, and the biological, physiological and functional effects from this pilot study, plans are underway by Cytori Therapeutics (NASDAQ: CYTX - News), the trial sponsor, to initiate a European medical device approval study for the Celution® System, the cell processing system used in the study.
DUSA Pharmaceuticals, Inc. (NASDAQ GM: DUSA), a dermatology company that is developing and marketing Levulan Photodynamic Therapy (PDT), today announced that the United States Patent and Trademark Office has issued a notice of allowance for a key patent related to its proprietary PDT light source, the BLU-U, Blue Light Photodynamic Therapy Illuminator. The new patent will have method of treatment claims which cover the use of DUSA's blue light technology and aminolevulinic acid HCL (Levulan) for the treatment of actinic keratosis as well as the diagnosis and treatment of other disease states such as acne, cancer, psoriasis and photodamaged skin. The patent also has claims that will cover DUSA's blue light technology in conjunction with its proprietary Levulan Kerastick formulation of aminolevulinic acid HCL. The patent, once issued, which is scheduled to occur on May 25, 2010, will cover their approved Levulan PDT therapy until June, 2019.
Halozyme Therapeutics, Inc. (Nasdaq:HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the first quarter ended March 31, 2010. "Halozyme continues to execute its strategy of leveraging our unique technology and advancing our diverse pipeline to position the company for future growth," said Jonathan Lim, M.D., Halozyme's president and CEO. "I am pleased with the progress that Halozyme and its alliance partners, Roche and Baxter, have achieved so far in 2010. The use of our rHuPH20 enzyme in these alliance programs will allow for subcutaneous administration that can potentially improve patient convenience, save healthcare resources, and, in the case of Herceptin SC, reduce the administration time to less than five minutes."
Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended March 31, 2010. The net loss (including non-cash expenses) for the fiscal quarter was approximately $4,044,000 or $0.03 per share compared to a loss of approximately $3,087,000 or $0.04 per share for the same period in 2009. Increased research and development costs were associated with the effort towards launch of Alferon N Phase II tests; activity preparatory for new clinical trials of Alferon LDO and Ampligen, both experimental therapeutics, along with an increase in overall general and administrative costs. Cash, cash equivalent and short-term investments were $51,723,000 as of March 31, 2010.
Icagen, Inc. (Nasdaq:ICGN) reported today its financial results and operational highlights for the first quarter ended March 31, 2010. For the first quarter of 2010, the Company reported revenues of $1.5 million and a net loss of $3.2 million. As of March 31, 2010, the Company's cash and cash equivalents totaled $14.3 million. "The first quarter of 2010 has been important in the progression of our lead compound, ICA-105665, along its clinical development path for epilepsy and pain. We were pleased to recently report positive results in our Phase IIa study in patients with photosensitive epilepsy and to have these results presented at the Tenth Eilat Conference on New Antiepileptic Drugs in Israel. Based upon the efficacy demonstrated in that study, as well as the safety profile in all clinical studies to date, we were pleased that the FDA was supportive of our plan to investigate higher doses of ICA-105665. These studies, the combined cost of which is expected to be approximately $1.0 million, will position us to optimize dose selection for potential future clinical trials," noted P. Kay Wagoner, CEO of Icagen, Inc.
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), today announced that the Food and Drug Administration has accepted for filing its abbreviated new drug application (ANDA) for a generic version of the antidepressant Effexor XR (venlafaxine hydrochloride). The Company's application will now proceed to full review by the FDA. Intellipharmaceutics endeavours to develop its pipeline products to an advanced stage, and will now seek a commercialization and distribution partner for this product in the United States.
Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced that it has completed the dose escalation stage of an ongoing Phase II study of CD-NP in patients with acute decompensated heart failure. Nile had previously announced that the study, NIL-CDNP-CT005, was expanded to permit additional dose exploration prior to proceeding to larger Phase II studies
AMRI (NASDAQ: AMRI) announced today that AMRI Senior Vice President, Administration and Chief Financial Officer Mark T. Frost will present at the Bank of America and Merrill Lynch 2010 Healthcare Conference in New York City on Thursday, May 13, 2010 at 9:20 a.m. EDT.
Catalyst Pharmaceutical Partners, Inc. (NasdaqCM: CPRX) announced that Jack Weinstein, Catalyst's Chief Financial Officer, will be making a presentation at the MoneyShow Conference to be held May 10th through May 13th at Caesars Palace in Las Vegas.
CorMedix Inc. (NYSE Amex: CRMD.U), a pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of cardiorenal disease, today announced that the units issued in CorMedix’s recent initial public offering will separate on May 13, 2010 instead of the currently scheduled separation date of May 23, 2010 following the determination by Maxim Group LLC, the representative of the underwriters of CorMedix’s initial public offering, that the earlier separation date is acceptable.
Daxor Corporation (NYSE Amex: DXR), a medical instrumentation and biotechnology company, today announced that two research reports were presented at the 32nd annual Society of Cardiovascular Anesthesiologists (SCA) conference in New Orleans, LA which involved the Daxor Blood Volume Analyzer (BVA-100).
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced that it has set Tuesday, July 13, 2010 as the date of its 2010 Annual Meeting of Stockholders, and that the record date for determining stockholders entitled to vote at the Annual Meeting is June 7, 2010.
Helix BioMedix, Inc. (OTCBB: HXBM), a developer of bioactive peptides, today announced financial results for the company's first quarter 2010 ended March 31, 2010.
Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today that its presentation at the Bank of America Merrill Lynch 2010 Health Care Conference will be webcast and may be accessed at www.hgsi.com.
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, announced today that it has priced a public offering of 9,000,000 shares of its common stock at a price of $8.00 per share.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced it will issue its first quarter 2010 investor update after the U.S. financial markets close on Tuesday, May 11, 2010.
Nature's Sunshine Products, Inc. (NASDAQ:NATR), a leading manufacturer and marketer of nutritional supplements and complementary products, today reported an increase in net sales of 4.7 percent to $87.0 million for the 2010 first quarter, compared with $83.2 million for the same period in 2009.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today reported the results of its first quarter ended March 31, 2010.
PhotoMedex, Inc. (Nasdaq: PHMD) announced today that it has closed on an underwritten public offering of 534,000 shares of its common stock at a price to the public of $6.00 per share for gross proceeds of $3,204,000.
QuantRx® Biomedical Corporation (OTCBB:QTXB), a broad-based diagnostic company focused on the development and commercialization of innovative diagnostic products, today announced that it has entered into a two-year agreement with VetRed BV for the European distribution of products developed by QuantRx (QN Diagnostics) for veterinary applications.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a focus in oncology and hematology, today announced the date and time for its first quarter 2010 corporate update and pipeline review conference call.
West Pharmaceutical Services, Inc. (NYSE:WST) today announced that its Board of Directors has approved payment of the third-quarter 2010 cash dividend of $0.16 per share.
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.