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EMD Serono Wins FDA Approval for Bavencio

  • Posted by Janet Tice
  • On April 20, 2017
The FDA has granted EMD Serono accelerated approval for Bavencio (avelumab), a drug for the treatment of metastatic Merkel cell carcinoma (MCC) a rare, aggressive form of skin cancer. This is the first FDA-approved treatment for metastatic MCC. “While skin cancer is one of the most common cancers, patients with a rare form called Merkel […]
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Paratek Announces Positive Results of Phase 3 Study of New Antibiotic

  • Posted by Janet Tice
  • On April 20, 2017
Paratek Pharmaceuticals has announced the second positive Phase 3 registration study of omadacycline, which will be used to support marketing applications to the FDA and EMA planned for 2018. The Phase 3 clinical study compares Paratek’s broad spectrum investigational antibiotic, omadacycline, to moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). “This successful […]
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Governor Baker Signals Continued Support for Life Sciences

  • Posted by ISPE Boston
  • On April 20, 2017
Governor Charlie Baker once seemed skeptical about continuing the 10-year, $1 billion life sciences initiative launched by his predecessor, Deval Patrick. At the MassBio annual meeting on March 31, Baker left no doubt that he’s all-in, outlining an ambitious vision for extending the initiative after its initial term expires at the end of 2018, saying […]
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FDA Gets High Marks for Speed of Drug Approval

  • Posted by Janet Tice
  • On April 20, 2017
In a letter to the editor published in the April 6, 2017 issue of the New England Journal of Medicine, researchers reported on results of a study comparing FDA and EMA review times for new therapeutic agents approved between 2011 and 2015. During this period, the FDA approved 170 new therapeutic agents and the EMA […]
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ISA Food and Pharmaceutical Industry Division 4th Annual Symposium Arrives in Framingham May 16-17

  • Posted by ispeblog
  • On April 10, 2017
Competitive forces, changing marketplace dynamics, and regulatory pressures are generating greater demand and need for new and more effective automation technologies in the pharmaceutical and food industries. More than ever before, manufacturing companies are seeking solutions and methodologies that increase quality, safety, reliability, profitability, cost control and production throughput. On May 16-17 at the Sheraton […]
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Sanofi Appoints Bill Sibold to Replace David Meeker

  • Posted by Janet Tice
  • On April 6, 2017
Sanofi has announced the appointment of Bill Sibold as Executive Vice President Sanofi Genzyme, effective July 1, 2017.  In this role, Mr. Sibold will be a member of the Executive Committee. He succeeds David Meeker, M.D., who will leave the company at the end of June after a distinguished 23-year career with Genzyme and Sanofi. Mr. […]
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Sanofi Genzyme and Regeneron Announce FDA Approval of First Targeted Biologic Therapy for Eczema

  • Posted by Janet Tice
  • On April 6, 2017
Sanofi and Regeneron Pharmaceuticals announced that the FDA has approved Dupixent, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD), a form of eczema, whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent is a human monoclonal antibody […]
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Vertex Phase 3 Cystic Fibrosis Drug Trials Show Promising Results

  • Posted by Janet Tice
  • On April 6, 2017
Vertex Pharmaceuticals Incorporated has announced results from two Phase 3 studies of the tezacaftor/ivacaftor combination treatment that showed statistically significant improvements in lung function in people with cystic fibrosis (CF) ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The 24-week EVOLVE study evaluated the combination treatment […]
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Keys to Successful Interviews: Behavioral Questions Matter

  • Posted by rfeldt
  • On April 6, 2017
Asking “behavioral” questions during an interview can make you a better hiring manager. And if you’re on the receiving end, having good answers ready will help you ace the interview and land that coveted position. But what are behavioral questions, anyway? Screening candidates for soft skills is often the toughest part of an interviewing for […]
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AiChE Boston Presents “Fundamentals of Bulk Solids Handling” on Saturday, April 29

  • Posted by ispeblog
  • On April 5, 2017
If you work with powders or other bulk solids and are interested in learning how to design bulk solid handling systems, this workshop is for you! Systems for handling powders and other bulk solids are often improperly designed, leading to: Erratic flow, no flow or limited throughputs Poor product quality and excessive downtime Customer complaints Safety issues including […]
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