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Featured Image

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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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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Amgen in Thousand Oaks, CA to Lay Off, Relocate 500 Employees, Some to MA

  • Posted by jwillard
  • On March 30, 2017
The Pacific Coast Business Times is reporting that on March 22, Amgen notified nearly 500 employees at their Thousand Oaks facility that they will be re-assigned, relocated, or laid off over the next year and a half. The reassigned employees will be transferred to a new facility in Tampa Bay or to R&D in Cambridge, […]
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Flexion Stock Soars on Report of Sanofi Takeover

  • Posted by Janet Tice
  • On March 30, 2017
As reported by Robert Weisman in The Boston Globe, following a report that Burlington-based Flexion Therapeutics is negotiating a sale to French drug giant Sanofi, Flexion shares rose more than 33 percent. Spokeswomen for Sanofi and Flexion — which has a promising knee pain drug up before US regulators — declined to comment. The purchase […]
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EMD Serono Wins FDA Approval for Drug to Treat Skin Cancer

  • Posted by Janet Tice
  • On March 30, 2017
The FDA has granted accelerated approval to Bavencio (avelumab) for the treatment of metastatic Merkel cell carcinoma (MCC). This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer, and EMD Serono’s first cancer drug launch. The drug has been approved for adults and pediatric patients 12 years and older, […]
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Biogen Wins Patent Ruling for $4 Billion MS Treatment

  • Posted by Janet Tice
  • On March 30, 2017
As reported by Robert Weisman in The Boston Globe, Biogen’s patent on its top-selling multiple sclerosis treatment, Tecfidera, was upheld by a legal ruling in which the U.S. Patent Trial and Appeal Board rejected a challenge by Texas hedge fund manager Kyle Bass. Bass has been working for years to invalidate key intellectual property rights […]
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Arrakis Therapeutics to Target RNA with Small-Molecule Medicines

  • Posted by Janet Tice
  • On March 23, 2017
Waltham-based Arrakis Therapeutics has completed a $38 million Series A financing led by Canaan Partners with participation by Pfizer, Celgene, and biotech industry leader Henri Termeer, among others. Arrakis was founded with a vision to create a proprietary, transformational discovery platform that identifies small-molecule drugs that act directly on disease-causing RNA.  The company was established […]
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