|Alkermes Announces Positive Results from ALKS 9070. FDA Accepts Submission Of NDA For Corcept.|
|By Staff and Wire Reports|
|Thursday, 30 June 2011 18:51|
Alkermes, Inc., (NASDAQ:ALKS), announced placebo-controlled study of ALKS 9070 in patients with schizophrenia, positive topline results from a phase 1b, double-blind, randomized studies.
ALKS 9070, a Alkermes molecule for the treatment of schizophrenia, is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.
Data from ALKS 9070 showed generally well tolerated, achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing. Based on these results, Alkermes plans to advance ALKS 9070 into pivotal development by the end of calendar 2011. The Company will meet with the FDA for an end of phase 2 meeting and full results from the trial will be submitted to an upcoming medical meeting.
Corcept Therapeutics Inc., (NASDAQ:CORT) announced that the FDA has accepted for filing CORLUX, a glucocorticoid receptor type II (GR-II) antagonist, the New Drug Application (NDA), which was submitted on April 15, 2011, for the treatment of the manifestations of Cushing's Syndrome.
The FDA has indicated that this application will receive a standard review and that the Prescription Drug User Fee Act (PDUFA) goal date for completion of its review is February 17, 2012.
Auxilium Pharmaceuticals, Inc. (NASDAQ:AUXL), a specialty biopharmaceutical company, today announced three year recurrence data from the Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study (CORDLESS) for XIAFLEX® (collagenase clostridium histolyticum) in the treatment of adult Dupuytren's contracture patients with a palpable cord.
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that Jean-Jacques Bienaime, Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, July 28, at 5:00 p.m. ET to discuss second quarter 2011 financial results.
CDEX Inc. (OTCBB: CEXI), a leading developer of chemical detection products, using patented technologies for use in healthcare, safety and security markets, recently presented the Pocket ID2™ device at the 2011 NHTSA Bi-Regional Law Enforcement Training Summit.
Dendreon Corporation (Nasdaq:DNDN) today announced significant milestones that support broad availability for on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
First China Pharmaceutical Group, Inc. (OTCBB: FCPG) ("First China" or the "Company") is pleased to announce its unaudited results for the fiscal year ended March 31, 2011.
Imagenetix, Inc. (OTCBB:IAGX) announced today it has appointed Bill Toomey to its board of directors.
Inovio Pharmaceuticals, Inc. (NYSE Amex:INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved compelling immune responses in a study of its multi-subtype DNA vaccine for foot-and-mouth (FMD) disease administered by Inovio's proprietary vaccine delivery technology in sheep, the second large animal in which this vaccine was evaluated.
Jiangbo Pharmaceuticals, Inc. (Nasdaq:JGBO) ("Jiangbo" or the "Company"), a pharmaceutical company with its principal operations in the People's Republic of China ("China"), today announced that it held its 2011 Annual Meeting of Stockholders (the ''Annual Meeting'') on June 28, 2011 in Laiyang City, Shandong Province, PRC.
OXIS International, Inc. (OTC Bulletin Board:OXIS) today announced that it has named David Saloff to its Board of Directors.
Rural/Metro Corporation (NASDAQ: RURL), a leading national provider of ambulance and private fire protection services, today announced the completion of its acquisition by affiliates of the global private equity firm Warburg Pincus, LLC. Pursuant to the terms of the previously announced Agreement and Plan of Merger dated March 28, 2011, the Company's stockholders will receive $17.25 per share in cash, without interest, less any applicable withholding taxes, for each share of Rural/Metro common stock owned.
Savanna East Africa, Inc. (PINKSHEETS: NVAE) (OTCQB: NVAE) plans to finalize the acquisition of a healthcare sector manufacturing company in July and announce two new acquisition letters of intent.
SCOLR Pharma, Inc. (OTC: SCLR) today announced that it has closed the second and final tranche of its previously-announced private placement of its 8% Senior Secured Convertible Debentures due 2013 (the "Debentures").
Tengion, Inc. (Nasdaq:TNGN) today announced that Steven A. Nichtberger, M.D., has resigned from his role as president, chief executive officer and member of the Company's Board of Directors.