|Arena Wins FDA Advisory Panel Backing for Obesity Pill|
|By Staff and Wire Reports|
|Thursday, 10 May 2012 18:26|
Advisers to government health regulators late Thursday recommended that they approve sales of what would be the first new prescription weight-loss drug in the U.S. in more than a decade, despite concerns over cardiac risks.
Shares of the drug's creator, Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), nearly doubled, jumping from $3.66 to $7.15 in after-hours trading after trading was temporarily halted.
A panel of expert advisers to the Food and Drug Administration voted 18-4 to recommend approval of Arena's lorcaserin, concluded that its benefits "outweigh the potential risks when used long term" in overweight and obese people. One panel member abstained from voting.In addition, Arena and Eisai Inc. announced the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. Lorcaserin is an investigational drug candidate intended for weight management.
In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US FDA.
PolyMedix (OTC: PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced an update on the development status of its anticoagulant reversing agent, PMX-60056. PolyMedix has stopped enrollment in two clinical trials for PMX-60056: a Phase 2 clinical trial for reversing the anticoagulant activity of unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention procedures, and a Phase 1B/2 clinical trial for reversing the anticoagulant activity of the low molecular weight heparin enoxaparin in healthy volunteers.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas at 8:00 a.m. Pacific time (11 a.m. Eastern time) on Thursday, May 17, 2012.
Alkermes plc (NASDAQ: ALKS) will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, May 17, 2012, to discuss the company’s financial results for its fiscal year ended March 31, 2012.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today final results from its completed Phase I clinical trial with ALN-TTR01, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).
The Board of Directors of AmerisourceBergen Corporation (NYSE: ABC) today authorized a new $750 million share repurchase program, effective immediately.
Anacor Pharmaceuticals (NASDAQ:ANAC) announced today its financial results for the first quarter ended March 31, 2012.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Jack Howarth, Vice President of Corporate Affairs, will present at the 15th Annual Bank of America Merrill Lynch Health Care Conference on Thursday, May 17, 2012 at 12:00 pm PDT.
A.P. Pharma, Inc. (OTCBB:APPA.OB), a specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2012 and highlighted recent corporate progress.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the Bank of America Merrill Lynch 2012 Health Care Conference in Las Vegas. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Wednesday, May 16, 2012 at 9:20 a.m. (PT).
CEL-SCI Corporation (NYSE AMEX: CVM) announced today financial results for the fiscal quarter ended March 31, 2012.
Codexis, Inc. (NASDAQ: CDXS), a developer of cost-advantaged processes for the production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced financial results for the first quarter ended March 31, 2012.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company specializing in oncology, today reported financial results for the three months ended March 31, 2012, and provided a business update.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that it will hold its Annual Meeting of Stockholders on Thursday, May 17, 2012 beginning at 9:00 AM Eastern at the InterContinental Harbor Court, 550 Light Street, Baltimore, Maryland 21202.
Exelixis, Inc. (NASDAQ:EXEL) announced today that Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, will present at the Bank of America Merrill Lynch 2012 Health Care Conference at 3:00 p.m. EDT / noon PDT on Thursday, May 17, 2012, in Las Vegas.
Fluidigm Corporation (NASDAQ:FLDM) today announced its financial results for the first quarter ended March 31, 2012.
GE Healthcare, the healthcare business of GE (NYSE: GE) announced today that it has completed the acquisition of Xcellerex, Inc., a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Bank of America Merrill Lynch 2012 Health Care Conference on Wednesday, May 16, at 10:40 a.m. PT.
Interleukin Genetics, Inc. (OTCQB: ILIU) today announced financial and operational results for the first quarter ended March 31, 2012.
International Stem Cell Corporation (OTCBB: ISCO) www.internationalstemcell.com today announced that the Company has developed new technologies to commercialize the use of human parthenogenetic stem cells (hpSC) to treat human diseases.
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced that James Scibetta, chief financial officer of Pacira Pharmaceuticals, is scheduled to present at the Bank of America Merrill Lynch 2012 Health Care Conference on Thursday, May 17, 2012, at 10:40 a.m. PT at The Encore at Wynn in Las Vegas.
PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, today announced that Michael J. Culotta, Executive Vice President and Chief Financial Officer, will make a presentation regarding the Company at the 11TH Annual JMP Securities Research Conference in San Francisco, California, on Monday, May 14, 2012, at 9:00 a.m. Pacific Time.
Response Genetics Inc. (Nasdaq:RGDX), (the “Company”), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced its consolidated financial results for the first quarter ended March 31, 2012.
RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) today announced that Geert Cauwenbergh, Dr. Med. Sc. has been appointed as the Company’s President and Chief Executive Officer.
RXi Pharmaceuticals Corporation (OTCBB: RXII.OB) announced today that the Financial Industry Regulatory Authority, Inc., also known as FINRA, has approved RXi Pharmaceuticals’ common stock for trading under the stock symbol “RXII” on the OTC Bulletin Board. RXi Pharmaceuticals anticipates its stock will be eligible for trading commencing today, May 10, 2012.
SDIX (Nasdaq: SDIX), a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic and food safety applications, today reported financial results for the quarter ended March 31, 2012.
Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today reported its financial results for the first quarter ended March 31, 2012.
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI) (Spectrum) and Allos Therapeutics, Inc. (NasdaqGS: ALTH) (Allos) today announced that, on May 9, 2012, each had received from the Federal Trade Commission (FTC) a Request for Additional Information and Documentary Material (Second Request) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, applicable to the acquisition of Allos by Spectrum.
Synageva BioPharma Corp. (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, will present at the upcoming Bank of America Merrill Lynch 2012 Health Care Conference being held in Las Vegas, Nevada.
TherapeuticsMD™, Inc. (OTCQB: TXMD), parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced that on May 10, 2012 it launched its third prescription prenatal vitamin, vitaMedMD™ RediChew™ Rx, following the successful launch of vitaMedMD™ One Rx earlier this month and vitaMedMD™ Plus Rx last month. vitaMedMD RediChew Rx is a small, vanilla flavored, chewable prenatal vitamin tablet that dissolves quickly and is taken once daily.
Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), today announced the appointment of Samuel R. Saks, M.D. (age 57) to the Company’s Board of Directors.