|Vivus Announces FDA Approval Of STENDRA Tablets; FDA to meet with Athersys on Clinical Development of GvHD|
|By Staff and Wire Reports|
|Friday, 27 April 2012 19:02|
UPDATE: VIVUS, Inc. (NASDAQ: VVUS) announced the U.S. FDA has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED," said Peter Tam, president, VIVUS. "We believe that the PDE5 selectivity and absorption profile of STENDRA make it an important new treatment option for many men with erectile dysfunction."
More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of STENDRA. STENDRA at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in STENDRA-treated patients compared to placebo.
Athersys, Inc. (Nasdaq: ATHX) announced a scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD).
Additionally, the Company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design. The Company intends to provide further information about its plans as it finalizes development of a detailed trial and statistical plan and receives additional FDA feedback.
Baxter International Inc. (NYSE:BAX) today announced the presentation of Phase III clinical data evaluating the safety and efficacy of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for the treatment of multifocal motor neuropathy (MMN).
Bristol-Myers Squibb Company (NYSE:BMY) invites investors and the general public to listen to a webcast of its annual meeting of stockholders at 10 a.m. (ET) on Tuesday, May 1, 2012.
Covidien plc (NYSE: COV) today reported results for the second quarter of fiscal 2012 (January-March 2012).
GenMark Diagnostics, Inc. (NASDAQ:GNMK) today announced that it plans to release its first quarter 2012 earnings results after market close on Tuesday, May 8, 2012.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today reported financial results for the three-month period ended March 31, 2012 – the third quarter of the Company’s 2012 fiscal year – and provided an update on ImmunoGen.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced that its Annual Meeting of Stockholders will be webcast live beginning May 1, 2012 at 9:00 a.m. Eastern Daylight Time via the Company Web site at www.labcorp.com.
Magellan Health Services Inc. (NASDAQ: MGLN) today reported financial results for the first quarter 2012, as summarized below. For the quarter ended March 31, 2012, the company reported net revenue of $773.2 million, segment profit of $55.4 million, and net income of $20.8 million or $0.75 per diluted common share.
Medtronic, Inc., (NYSE: MDT), announced today six month pooled outcomes from randomized and crossover patients in the Symplicity HTN-2 clinical trial following renal denervation with the Symplicity™ renal denervation system showing significant, sustained blood pressure reduction in patients with treatment-resistant hypertension.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. District Court for the District of New Jersey has ruled in Merck's favor in two jointly related patent infringement suits against Mylan Pharmaceuticals Inc.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the first quarter of 2012.
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the Company will report its financial results for the first quarter of 2012 on Wednesday, May 2, 2012 after market close.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced today that it will report its first quarter 2012 financial results on Thursday, May 3, 2012 at approximately 4:30 p.m. ET.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software and consulting services for pharmaceutical discovery and development, announced today the release of Version 8.0 of its flagship GastroPlus™ simulation software with significantly expanded functionality and user convenience.
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) and CJ CheilJedang Corporation today announced that they have entered into an exclusive collaboration under which CJ CheilJedang will commercialize Silenor® (doxepin) for the treatment of insomnia in South Korea.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) announced today that it has been notified by the International Court of Arbitration, International Chamber of Commerce (ICC), that the anticipated date of the arbitration decision in its demand for arbitration under the applicable provisions of the Collaboration and License Agreement with Takeda Pharmaceuticals Company Limited, or Takeda, has been extended from April 30, 2012 to May 31, 2012.
As health officials in Arizona are urging residents to make sure they’re vaccinated against pertussis, or whooping cough, Walgreens (NYSE: WAG)(NASDAQ: WAG) is offering immunizations that provide protection against the highly-contagious respiratory infection (tetanus/diphtheria/pertussis-Tdap vaccine) at all of its more than 275 points of care throughout the state.