|MELA Sciences gains on analyst comments. After the bell: FDA panel says no to JAZZ. Cumberland falls on PDUFA delay|
|By BioMedReports.com Staff|
|Friday, 20 August 2010 17:38|
Below is a list of the companies that made news in the healthcare sector on Friday, August 20, 2010.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced after the bell today that the Joint Advisory Committee of the U.S. Food and Drug Administration, including the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 20-2 that the benefit/risk balance did not support the approval of JZP-6 for the treatment of fibromyalgia with the currently proposed Risk Evaluation Mitigation Strategy (REMS).
"While we are disappointed with the recommendation of the Joint Advisory Committee, we plan to work closely with FDA on the continuing review of our new drug application (NDA)," said Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals, Inc. "We will carefully consider the input of the Committee as we seek to address the needs of fibromyalgia patients for new treatment options in a safe and responsible way."
In extended trading shares of Jazz traded as low as $5.90 before edging back up and closing at $7.31, down $2.92 or 28.54%.
Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX) today after the market closed announced the U.S. Food and Drug Administration has extended its review of the supplemental new drug application (sNDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. The review has been extended by three months resulting in a new Prescription Drug User Fee Act (PDUFA) goal date in December 2010.
"We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals.
In the after hours market shares of Cumberland fell more than 10% or 62 cents to $5.40.
MELA Sciences, Inc. (NASDAQ:MELA) surged nearly 10% today after Boenning and Scattergood analyst Greg Chodaczek expects a positive FDA panel review for the company's melanoma detection device. The FDA panel is set to review the device on Nov. 18th, moving from the original scheduled date of August 26th. Chodaczek expects an ultimate FDA approval in the 1st quarter of 2011. Shares of MELA closed up 62 cents to close Friday's trading at $6.87.
Also Friday:Accelrys, Inc. (NASDAQ: ACCL), the leading scientific informatics software and services company, will participate in the ACS Fall 2010 Conference being held at the Boston Convention & Exhibition Center from August 22-25, 2010.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has been notified that the US Patent and Trademark Office (USPTO) will allow a patent issuance of its application No. 11/785,249 entitled "Antibiotic Resistance Free Vaccines and Methods for Constructing and Using Same."
Angeion Corporation (NASDAQ: ANGN) today announced that it will release its fiscal 2010 third-quarter results on Wednesday, August 25, 2010, at market close.
BioTime, Inc. (NYSE Amex:BTIM) announced the completion of its warrant discount offer which closed at 5:00 p.m., New York time, on August 18, 2010.
Chai-Na-Ta Corp. (OTCBB:CCCFF), one of the world's largest suppliers of North American ginseng, today announced a second quarter 2010 net loss of $158,000, or less than $0.01 per basic share, compared to a net earnings of $1.5 million, or $0.04 per basic share, in the same period last year.
Catalyst Health Solutions, Inc., (NASDAQ: CHSI), announced today that it was named to the 2010 Fortune 100 Fastest-Growing Companies List. Catalyst has achieved this recognition for three consecutive years and four times in six years. The Company was also named on Fortune's Fastest-Growing All-Stars List.
Electronic Control Security, Inc. (OTCBB: EKCS) (ECSI), a global leader in perimeter security systems, today announced receipt of orders totaling $1.1 million for security upgrades at several U.S. Air Force bases and nuclear power stations to meet updated force protection and NRC requirements.
Environmental Tectonics Corporation's (OTC Bulletin Board: ETCC) Biomedical Systems, a worldwide leader in the development, manufacture of computerized monoplace hyperbaric chambers, today confirmed that it has received FDA 510-k clearance for O.S.C.A.R.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced receipt of a Paragraph IV Certification Notice Letter advising that Sigmapharm Laboratories, LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Hepsera® (adefovir dipivoxil).
Hospira, Inc. (NYSE:HSP), a global specialty pharmaceutical and medication delivery company, today announced that Christopher B. Begley, chairman and chief executive officer (CEO), has indicated his intent to retire from the CEO position after more than six years of dedicated service.
ICON plc (NASDAQ:ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the appointment of Mr. Alan Morgan to the position of Group President, Clinical Research Services.
Renhuang Pharmaceuticals, Inc. (NYSE Amex:CBP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines, today announced that, it has appointed Ms. Xiaoying Lu as its Interim Chief Financial Officer, while the Company seeks a permanent replacement.
Warner Chilcott plc (Nasdaq:WCRX) today announced that it has completed an amendment to its existing senior secured credit facilities, pursuant to which it has incurred an additional $1.5 billion aggregate principal amount of new term loans.
XTend Medical Corporation (PINKSHEETS: XMDC), a company that specializes in delivering life-changing medical technology to healthcare organizations globally, received confirmation that the Delaware Chancery Court has scheduled a mediation of the lawsuit that XTend commenced against U&I Bio-Tech Korea, U&I Bio-Tech California, Mr. Sam Lee, and Mr. Eric Shin.
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.