|BSD Medical provides info to FDA, shares rise. Fonar surges on Upright MRI study. After the bell: MELA drops after FDA moves panel meeting|
|By BioMedReports.com Staff|
|Wednesday, 21 July 2010 18:21|
Below is a list of the companies that made news in the healthcare sector on Wednesday, July 21, 2010.
MELA Sciences, Inc. (NASDAQ:MELA) announced after the bell today that the U.S. Food and Drug Administration has informed the company that it is moving the General and Plastic Surgery Devices Panel for MelaFind, which was originally scheduled for August 26, 2010, to November 2010.
"The FDA informed us today that more time is required to arrange the meeting," said Joseph V. Gulfo, MD, President & CEO. "We are ready to go now, and we will maintain our state of preparedness. This is untimely, however, it is not totally surprising given that the meeting was originally scheduled for the last week of the summer. We look forward to the revised Federal Register announcement of the specific date in November."
After the bell, shares of MELA fell more than 10%, dropping 66 cents to $5.81.
In news from earlier in the day:
BSD Medical Corporation (NASDAQ: BSDM) rose more than 8% today after the company announced that it has provided the additional information requested by the U.S. Food and Drug Administration for review of the 510(k) submission the Company filed for premarket clearance of the Company's Phase II MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue.
"We responded quickly to the request for additional information from the FDA in order to expedite the review process," stated Harold Wolcott, President of BSD. "While we cannot predict the ultimate outcome or when the review will be completed, we are optimistic about the outcome."
FONAR Corporation (NASDAQ:FONR), The Inventor of MR Scanning announced today new breakthrough results for the FONAR UPRIGHT Multi-Position MRI. The medical journal "Brain Injury" has just released the exciting results of a study of 1200 neck pain patients. The study was published by 10 authors from distinguished universities in the U.S. and around the world of their results from the scans of 1200 patients. Their study reported that 150% more whiplash patients had demonstrable radiographic pathology when scanned upright than when they were scanned lying down (recumbent). Their investigation also reported that "patients with a history of motor vehicle crash-associated neck pain have a substantially higher frequency of cerebellar tonsillar ectopia (CTE)* of 1mm or more than non-traumatic subjects" when examined by the FONAR UPRIGHT MRI. As the authors reported, the frequency of these fallen cerebellar tonsils (CTE)* was found "4 times more often" in neck pain patients who had experienced whiplash trauma versus neck pain patients that had not experienced recent trauma, when the FONAR UPRIGHT® MRI scanner was used.
The authors further reported, "CTE (tonsil ectopia) was found 2.5 times more often in the upright trauma vs. the recumbent group" if the patients were scanned in the FONAR UPRIGHT Multi-Position MRI. In sum the anatomic origin of the patient's whiplash symptoms was successfully visualized 2.5 times more frequently when the patient was scanned upright in the FONAR UPRIGHT Multi-Position MRI than when he/she was scanned lying down in the conventional recumbent-only MRI.
The upright MRI examination, therefore, now makes it possible to provide definitive radiographic evidence and image characterization of the pathology giving rise to a patient's whiplash symptoms so that it can be medically treated. For the first time, definitive anatomic evidence of the injuries sustained by whiplash victims in a motor vehicle accident can be provided. Currently, as the authors point out, some claim that patient whiplash pain is "non-pathologic chronic pain" engendered by "psychosocial factors such as litigation." The newly published results from the FONAR UPRIGHT® Multi-Position™ MRI establish that this is not correct.
Shares of Fonar rose more than 11% on the news, closing the day at $1.59, up 16 cents.
Amicus Therapeutics (Nasdaq:FOLD) announced today that the Company's Chairman and CEO, John F. Crowley, testified on behalf of the Biotechnology Industry Organization (BIO) at the Senate Committee on Health, Education, Labor and Pensions bipartisan, full committee hearing focused on rare and neglected diseases held on Wednesday, July 21 on Capitol Hill. Mr. Crowley, a member of the Board of Directors of BIO, provided background and perspectives on the current state of drug development for orphan products. He also made a series of recommendations to the Committee regarding the establishment of additional incentives for companies to develop more treatments for rare and neglected diseases.
Cephalon, Inc. (Nasdaq:CEPH) today announced that, based on preliminary financial results, it expects sales and basic adjusted income per common share for the second quarter 2010 to exceed its previously issued guidance driven largely by strong product sales. The company now anticipates that sales for the second quarter 2010 will be between $705-715 million, up from the previous sales guidance of $645-670 million.
NovaBay Pharmaceuticals, Inc. (NYSE Amex:NBY) today announced that its lead product candidate was safe and efficacious against the highly contagious skin infection impetigo in a Phase 2a proof-of-concept clinical trial. This dose-ranging study showed that the drug cleared impetigo infections, including those in the trial caused by a drug-resistant strain of bacteria called methicillin-resistant Staphylococcus aureus or MRSA. Impetigo afflicts approximately 1 million people, primarily infants and children, in the United States annually.
Shares of Novabay jumped more than 13% on the news before pulling back later in the day. The stock closed trading at $2.09, up 3.52%.
Osiris Therapeutics, Inc.(NASDAQ: OSIR) announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company’s New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD). Based on a separate review of summary clinical data, Health Canada has notified Osiris that the application has been granted Priority Review, shortening the examination period from 300 to 180 days. If successful, Prochymal would become the world’s first approved stem cell therapy.
Radient Pharmaceuticals Corporation (AMEX:RPC), announced today it has entered into an exclusive distribution agreement with AMDL Australia Pty Ltd. to market and commercialize RPC's Onko-Sure™ in vitro diagnostic (IVD) cancer test in Australia and New Zealand.
Led by a strong management team of well-respected physicians and diagnostics professionals, AMDL Australia Pty Ltd. is an established, privately-owned distributor of healthcare products to laboratories, clinics, hospitals and other health care providers and research organizations throughout Australia and New Zealand. The company is the newest addition to Radient Pharmaceuticals' portfolio of international distributors and under the terms of the agreement, will market, sell and distribute at minimum 3700 Onko-Sure IVD cancer test kits for use as a monitoring test for colorectal cancer (CRC) in Australia and New Zealand. AMDL Australia also holds responsibility for developing and executing a full-scale marketing strategy to drive product awareness and engage healthcare decision makers, thought-leaders, lab directors, physicians, patients and healthcare consumers in product purchases. Targeted distribution channels will include medical centers, hospitals, clinical laboratories, university labs.
Abbott (NYSE:ABT) today announced better than expected financial results for the second quarter ended June 30, 2010.
Affymetrix, Inc. (NASDAQ:AFFX) today announced the launch of QuantiGene® ViewRNA Assay formats, which enable a new era of "in situ multiplex gene expression analysis" by allowing drug screening of native cells and advancing the pace of biomarker disease research and stem cell studies.
Alere Inc. (NYSE:ALR), a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, today announced that it will release its second quarter 2010 earnings on Wednesday, July 28, 2010.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report unaudited consolidated financial results for the quarter ended June 30, 2010 after the .S. financial markets close on July 28, 2010.
AMRI (NASDAQ: AMRI) has commenced enrollment for a Phase I study of ALB-127158(a), a novel MCH1 receptor antagonist offering a potential new approach for the treatment of obesity.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will hold a live webcast of its quarterly conference call at 8:30 a.m. (ET) on Wednesday, August 4, 2010.
BioTime, Inc. (AMEX:BTIM) announced today that on August 1, 2010 the Company will be offering for sale 21 new stem cell products for research use only.
Chembio Diagnostic , Inc. (OTCBB: CEMI), which develops, manufactures, markets and licenses point of cared diagnostic tests, announced today that the Company will release financial results for the second quarter 2010, before the open of the market on Thursday, July 29, 2010.
Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that it is scheduled to report second quarter results on Wednesday, July 28, 2010 at 4:00 p.m. Eastern Time.
Dyax Corp. (NASDAQ:DYAX) will host a webcast and conference call, including an open question and answer session, Wednesday, July 28, 2010, to discuss its financial results and company progress for the second quarter ended June 30, 2010
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company will host a conference call and question-and-answer session on July 28, 2010, at 10 a.m. EDT, to discuss the company's second-quarter 2010 financial results.
Flamel Technologies (NASDAQ: FLML) expects to release its financial results for the second quarter of 2010 on Wednesday, July 28th, after the market close.
GE Healthcare, a unit of General Electric Company (NYSE:GE), in collaboration with Cincinnati Children's Medical Center and the Davis Heart and Lung Institute of The Ohio State University, was awarded $1 million for (MRI) magnetic resonance imaging and devices for the "Pediatrics Population" project.
Genzyme Corp. (NASDAQ: GENZ) today reported that second-quarter revenue was $1.08 billion, compared with $1.23 billion in the same period last year, reflecting limited shipments of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) due to product supply constraints in 2010.
Greatbatch, Inc. (NYSE: GB) announced today that it will host a conference call on Wednesday, July 28, 2010 at 5:00 p.m. E. T. to discuss its financial results for the second quarter ended July 2, 2010.
ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced it will release second quarter 2010 financial results after market on August 4, 2010.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced the appointment of Joseph Feczko, M.D. to the Company's Board of Directors.
MWI Veterinary Supply, Inc. (NASDAQ: WIV) announced today that the Company will release financial results for its fiscal year 2010 third quarter ended June 30, 2010 and update its business outlook for its fiscal year ending September 30, 2010 on Thursday, July 29, 2010.
NovaMed, Inc. (Nasdaq: NOVA) announced today that it will host a conference call on Thursday, July 29, 2010 at 10:00 a.m. Eastern Time to discuss its results for the second quarter ended June 30, 2010.
Osiris Therapeutics, Inc. (NASDAQ: OSIR) announced today that the Biologics and Genetic Therapies Directorate of Health Canada has completed its initial evaluation and accepted for full review the company's New Drug Submission (NDS) of Prochymal (remestemcel-L), an adult stem cell therapy for the treatment of graft vs. host disease (GvHD).
POZEN Inc. (NASDAQ: POZN), announced today that it plans to release second quarter 2010 results on August 3, 2010, before the market opens.
PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced initiation of a Phase II clinical trial of hGH-CTP, the company's proprietary biobetter version of human growth hormone (hGH).
RTI Biologics Inc. (RTI) (Nasdaq:RTIX), a leading processor of orthopedic and other biologic implants, will be releasing financial results from the second quarter n Wednesday, Aug. 4, 2010 before the market opens.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced that the company will release its second quarter 2010 financial results on Wednesday, July 28, 2010, after the market closes.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today announced that detailed results from two Phase 3 clinical trials of the company's product Silenor® (doxepin) have been accepted for publication in peer-reviewed scientific journals.
SPX Corporation (NYSE:SPW) today announced that it has completed the acquisition of the Anhydro business, a Soeborg, Denmark-based global supplier of liquid concentration equipment, powder processing solutions, and dewatering plants and equipment.
Synovis Life Technologies, Inc. (NASDAQ: SYNO), a leading biomaterial and surgical products company founded in 1985, today celebrates its 25th anniversary.
United Therapeutics Corporation (Nasdaq: UTHR) announced today that it will release its second quarter 2010 financial results before market open on Wednesday, July 28, 2010.
ViroPharma Incorporated's (Nasdaq: VPHM) second quarter financial results for 2010 are expected to be released on Wednesday, July 28, 2010 before the open of the U.S. financial markets.
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