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  • Double Manufacturing Deals for Sanofi
    After the transfer is complete, Vivus will be submitting amendments to the already-approved avanafil regulatory applications to the FDA and EMA to include Sanofi as a qualified ...
    8-1-2013
  • Big Need in IBD: Drugs to Slow Progression
    ... The company filed a marketing authorization application with the EMA in March and the FDA in June for the gut-selective humanized monoclonal antibody as a treatment for adults with ...
    8-1-2013
  • Kemwell Biopharma Acquires Cirrus Pharmaceuticals
    Kemwell will now provide customers with a complete solution from early development in the U.S. to commercial manufacturing in Kemwell's EMA-, FDA-, and PMD-approved facilities in ...
    7-26-2013
  • EFPIA, PhRMA: Trial Data-Sharing Benefits Patients, Scientists...
    These companies will work with regulators at FDA, EMA, and/or national authorizes of EU member states to provide clinical trial results summaries upon approval of new medicines or ...
    7-25-2013
  • Across Pharma, Few Open Arms for Trial Data Sharing
    limited sharing as EMA, GSK press for open access. When it comes to sharing clinical trial data, at one end of the spectrum is the European Medicines Agency (EMA), which has drawn ...
    7-8-2013
  • Gene Editing with Multiple Molecular Means
    ... The European Medicines Agency, or EMA, has designated ataluren as an orphan medicinal ... authorization application, or MAA, to the EMA for conditional approval of ataluren for ...
    6-12-2013
  • Flexibility in Biopharmaceutical Manufacturing Capacity
    ... CellTrion and Hospira submitted biosimilar antibody approval applications to the EMA in 2012, with the expectation that those products will be launched in the European Union ...
    5-28-2013
  • Companion Diagnostics: 52 Pick-Up
    ... AB Science will retain full rights to the markers upon FDA marketing authorization of masitinib, which has been designated an orphan drug by FDA and EMA. Financial terms not ...
    5-9-2013
  • Biosimilars: 10 Drugs to Watch
    by 2017, according to Frost & Sullivan. EMA defines biosimilars as "similar to a biological medicine that has already been authorized, the so-called reference medicinal product." ...
    4-22-2013
  • Predicting Drug Toxicity in Humans
    ... This observation led FDA and EMA to adopt mRNA expression screening into their guidelines for drug-drug interaction studies, noted Dr. Boriss. "The sheer simplicity of the TRAC ...
    4-1-2013
  • Exploiting Folate Pathways to Treat Cancer
    accepted by the European Medicines Agency (EMA) in November 2012. Merck teamed up with ... The EMA granted vintafolide the equivalence of orphan drug status in March 2012, because ...
    4-1-2013
  • Personalized Medicine: Translation of Concepts
    ... This is in line with recent guidance for biomarker qualification from the Food Drug Administration (FDA) and the European Medicines Agency (EMA). Fortunately, multiple ...
    3-19-2013
  • Biosimilars: Not So Far So Fast
    ... The proverbial "canary in the coal mine" for biosimilars may be Celltrion's CT-P13 (Remsima). The South Korean company filed for approval for the infliximab biosimilar with the EMA...
    3-15-2013
  • Cangene Inks $300+M Deal for Bankrupt Inspiration's IB1001
    ... In Europe, IB1001 is under regulatory review by the European Medicines Agency (EMA), which is studying a Marketing Authorization Application submitted by Cangene in August 2011. ...
    2-20-2013
  • Plant-Based Protein Biomanufacturing
    ... Biopharmaceutical manufacturers already conversant with standard FDA, cGMP, ISO 9001, and EMA quality control and regulatory frameworks may hesitate to also place themselves under ...
    2-15-2013
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    Journal Articles

  • The Committee for Advanced Therapies' (CAT) reflection paper...
    Alessandro Aiuti, Giulio Cossu, Pablo de Felipe, Maria Cristina Galli, Gopalan Narayanan, Matthias Renner, Axel Stahlbom, Christian K Schneider, Caroline Voltz-Girolt
    Human Gene Therapy and Part B: Methods
    In the European Union, the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) takes the lead in the scientific assessment for marketing authorisation ...
  • Hypoxia: Adapting to High Altitude by Mutating EPAS-1 , the Gene...
    Martha C. Tissot van Patot, Max Gassmann
    High Altitude Medicine & Biology
    Then HIF-2 was identified (Ema et al. 1997, Flamme et al. 1997, Hogenesch et al. 1997, and Tian et al. 1997) and although it is highly similar to HIF-1 and has the potential to ...
  • Lessons Learned from the Clinical Development and Market Authorization...
    Laura M Bryant, Devin M Christopher, April R Giles, Christian Hinderer, Jesse L Rodriguez, Jenessa B Smith, Elizabeth A Traxler, Joshua Tycko, Adam P Wojno, James M. Wilson
    Human Gene Therapy and Part B: Methods
    review and eventual authorization by the EMA. As is the case with most pioneering ... and clinical data and the deliberations of the EMA and its associated committees. ...
  • Regulatory Aspects of Phase 3 Endpoints for New Inhaled Antibiotics...
    Alan Bruce Montgomery, Tammy Abuan, Melissa A. Yeager
    Journal of Aerosol Medicine and Pulmonary Drug Delivery
    However, there is not currently an accepted tool that can be used as a primary endpoint for the FDA or the EMA, although the latter recognizes the CFQ-R as a validated secondary ...

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