Industry News

• Mayo Clinic study finds mild cognitive impairment is more common in men  A Mayo Clinic study found that the prevalence of mild cognitive impairment was 1.5 times higher in men than in women. The research also showed a prevalence rate of 16 percent in the population-based study of individuals aged 70-89 without dementia who live in Olmsted County, Minn.
  Mayo Clinic September 06, 2010  
• MedImmune receives complete response letter on motavizumab   MedImmune announced that it has received a second complete response letter on motavizumab from the FDA which requested evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population(s) for which the prophylaxis indication is being requested.
  MedImmune, LLC. September 05, 2010  
• Celsion receives SBIR grant to expand Its technology platform  Celsion has been awarded a Phase I Small SBIR grant from the NIH, to support the proposal, "New Thermal Sensitive Carboplatin Liposomes for Cancer". This funding will support the Company's efforts to develop its proprietary heat-activated liposomal technology in combination with carboplatin.
  Celsion Corporation September 03, 2010  
• Celgene officially notified of ANDA filing for REVLIMID(R)  Celgene announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the FDA. The application requests authorization to manufacture and market generic versions of REVLIMID(R) in the U.S.
  Celgene Corporation September 03, 2010  
• Tibotec seeks European Marketing Authorization for once-daily HIV treatment TMC278  Tibotec Pharmaceuticals announced its submission of a Marketing Authorisation Application to the European Medicines Agency for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor for the treatment of HIV.
  Tibotec Pharmaceuticals September 03, 2010  
• European Commission issues positive decision for approval of Seroquel XR  AstraZeneca announced the European Commission issued a positive decision for the approval of once-daily SEROQUEL XR Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder who had sub-optimal response to antidepressant monotherapy.
  AstraZeneca September 02, 2010  
• New England Journal of Medicine reports Xpert MTB/RIF a faster Tuberculosis test  New England Journal of Medicine reports Xpert MTB/RIF a faster, more Cepheid announced that its Xpert(R) MTB/RIF test was the subject of a study published in the latest edition of the New England Journal of Medicine (NEJM), "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance."
  Cepheid September 02, 2010  
• Allergan resolves investigation of past sales and marketing practices related to BOTOX(R)  Allergan announced a resolution with the U.S. Department of Justice regarding Allergan's past U.S. sales and marketing practices relating to therapeutic uses of BOTOX. Allergan pled guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005 and will pay $375 million.
  Allergan, Inc. September 01, 2010  
• Implant Sciences appoints Bruce Bower as senior vice president  Implant Sciences announced the appointment of Bruce Bower into the newly created position of Senior Vice President. In this position, Mr. Bower will lead Implant Sciences' marketing and sales efforts.
  Implant Sciences Corporation September 01, 2010  
• Merck and Cardiome annoumnce BRINAVESS for infusion approved in the European Union  Merck and Cardiome Pharma Corp. announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation.
  Merck & Co., Inc. September 01, 2010  

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