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TMCNet:  EMA Wants VIVUS's Cardio Outcomes Trial on Qsiva; Alexza Wins Marketing Authorization for ADASUVE, Shares Soar

[February 21, 2013]

EMA Wants VIVUS's Cardio Outcomes Trial on Qsiva; Alexza Wins Marketing Authorization for ADASUVE, Shares Soar

(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on February 21, 2013.VIVUS, Inc. (Nasdaq: VVUS) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) confirmed its October 18, 2012 decision to decline the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union.VIVUS had requested a re-examination of the opinion. After considering the grounds for this request, CHMP again declined the marketing authorization on February 21, 2013. In its consideration of the Qsiva MAA, CHMP indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety."We are disappointed with the CHMP decision regarding Qsiva and the position the Committee adopted with respect to the need for a preapproval cardiovascular outcomes trial," said Peter Y. Tam, president of VIVUS. "We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favorable safety and efficacy profile of Qsiva. Despite the positive recommendation of CHMP's own Scientific Advisory Group (SAG) and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery."Qsiva was approved by the U.S. FDA in July 2012 and is sold under the trade name Qsymia™. The pivotal Phase 3 clinical trial program included over 4,500 subjects studied up to two years, establishing Qsymia as a safe and effective treatment for obesity.=======Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A., announced the European Commission has granted marketing authorization for ADASUVE ( Staccato loxapine). In the European Union (EU), ADASUVE, 4.5 mg and 9.1 mg inhalation powder loxapine, pre-dispensed, is authorized for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The ADASUVE marketing authorization requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that ADASUVE is administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).Also Thursday:Abbott (NYSE: ABT) announced today that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott's proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.Digirad Corporation (NASDAQ: DRAD), a leading provider of diagnostic imaging products, and personnel and equipment leasing services, today announced the launch of their Molecular Breast Imaging Accessory for the ergo™ Imaging System, further expanding the clinical flexibility of the ergo™ Imaging System for applications in the area of women's health, as well as in nuclear medicine where the ergo™ Imaging System is currently used for a wide variety of clinical applications.Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, is scheduled to present at the Citigroup 2013 Global Healthcare Conference at the Hilton New York Hotel on Monday, February 25, 2013.GenSpera, Inc. (OTCBB:GNSZ) announced that the first patient has been treated in the Phase II clinical trial of its lead compound, G-202, in patients who have hepatocellular carcinoma (HCC).Health Sciences Group (OTC Pink: HESG) today announced that management has taken necessary steps this week to file OTC Full Disclosure documents and financials to update to highest tier status on OTCMarkets. ICON plc, (NASDAQ: ICLR), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the appointment of Professor William Hall as a non-executive director.InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the fourth quarter and full year ended December 31, 2012.IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the first international implementation of IsoRay's exclusive GliaSite Radiation Therapy System (balloon catheter) at the University Hospital of Rostock, Germany.KineMed, Inc., Isis Pharmaceuticals Inc. (NASDAQ: ISIS), and CHDI Foundation, Inc., announced today that they are collaborating to utilize KineMed’s translational biomarker platform with Isis’ antisense therapeutic program for Huntington’s disease (HD).Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2012.Life Technologies Corporation (NASDAQ: LIFE) today announced it will present at Barclays Global Healthcare Conference on March 13 at 11:15 a.m. ET. Ron A. Andrews, Life Technologies' President of Medical Sciences, will present on behalf of the company.Medidata Solutions (NASDAQ: MDSO), a leading global provider of cloud-based clinical technology solutions that enhance the efficiency of clinical development, today announced its financial results for the fourth quarter and full year 2012, and provided detailed financial guidance for the first quarter and full year 2013. Milestone Scientific Inc. (OTCQB: MLSS), the recognized leader in advanced, computer-controlled injection technologies, today announced that Leonard Osser, Chief Executive Officer, will be conducting a live web presentation on BoardVote.com.Today, National Traders Association announced new research reports highlighting Novogen Limited (NASDAQ: NVGN), Sanofi SA (NYSE: SNY), ISIS Pharmaceuticals, Inc. (NASDAQ: ISIS), Amgen, Inc. (NASDAQ: AMGN)and Gilead Sciences, Inc. (NASDAQ: GILD).Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)today reported its financial results for the full year and fourth quarter 2012 and provided a business update.Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, announced today that it has filed for patent protection on novel new emitter technology that it believes will significantly expand the applications for its directional 3D audio systems.Pfizer Inc. (NYSE: PFE)today announced top-line results for a Phase 3 study that showed Lyrica® (pregabalin) Capsules CV were as effective as levetiracetam as an adjunctive therapy in adult epilepsy patients experiencing refractory partial onset seizures.Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today reported financial results for the three- and twelve-month periods ended December 31, 2012.Unilens Vision Inc. (OTCQB: UVIC) (TSX VENTURE: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today announced the launch of its new silicone hydrogel disposable C-Vue® HydraVUE™Multifocalcontact lens for monthly replacement. VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) is pleased to announce the completion of a software package for 3D Echocardiography (3DE) - the newest addition to the software capabilities of its knowledge-based-reconstruction (KBR) family of VMS™ heart analysis systems.


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