Posted on March 24, 2010 by BioJobBlogger

FDA to Impose Regulatory Sanctions on Genzyme

Orphan drug manufacturer Genzyme today issued a press release that the US Food and Drug Administration (FDA) notified the company that it intends to take enforcement action to ensure that products manufactured at its troubled biomanufacturing facility in Allston Landing, MA are made in compliance with good manufacturing practice regulations.

The agency’s enforcement action will likely result in a consent decree under which a third party would inspect and review the plant’s operation for an extended period and certify compliance with FDA regulations. Under a consent decree, Genzyme also would be required to make payments to the government and could incur other costs.

The Allston Landing facility was experiencing product quality problems for some time before FDA intervened and threatened regulatory action and sanctions against the orphan drug producer. According to the press release Genzyme will:

work cooperatively with the FDA to restore the agency’s confidence in its ability to operate the Allston plant at the highest standards, building on the progress it has made over the past year to address the manufacturing deficiencies at the Allston plant. This progress includes:

  • Retaining a leading quality assurance advisory firm to help develop a comprehensive strategy and risk mitigation plan. More than 30 expert consultants from this firm are currently working at the Allston plant or at other Genzyme manufacturing facilities.
  • Naming a new site head and reorganizing and strengthening the management team at the facility.
  • Hiring two highly regarded industry veterans to serve as President of Global Manufacturing and Corporate Operations and Senior Vice President of Global Product Quality.

While this is not good news for Genzyme, it is great news for patients who rely on Genzyme’s medicines to manage their oft times devastating and potentially life threatening genetically-inherited diseases.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

 

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Posted on December 29, 2009 by BioJobBlogger

The State of Massachusetts Offers Tax Incentives to 28 Life Sciences Companies to Sustain Its Biotechnology Workforce

Governor Deval Patrick and the Massachusetts Life Sciences Center announced today that the Center’s Board of Directors has awarded $25 million in Tax Incentives to twenty-eight life sciences companies. The companies receiving tax incentive awards have committed to creating a combined 918 new jobs in the Commonwealth over the coming year. The companies that received awards include many of state’s largest biotechnology companies e.g. Biogen, Genzyme, Sepracor and Cubist, as well as some smaller private and public ones (see below) 

  1. Alnylam Pharmaceuticals, Inc. (Cambridge) — $300,000
  2. Biogen Idec MA, Inc. (Cambridge) — $1,500,000
  3. Constellation Pharmaceuticals, Inc. (Cambridge) — $513,252
  4. Cubist Pharmaceuticals, Inc. (Lexington) — $1,740,000
  5. Dyax Corporation (Cambridge) — $100,000
  6. Facet Solutions (Hopkinton) — $300,000
  7. FoldRx Pharmaceuticals, Inc. (Cambridge) — $510,000
  8. Genzyme Corporation (Cambridge/Framingham) — $6,000,000
  9. GTC Biotherapeutics, Inc. (Framingham) — $300,000
  10. Hologic, Inc. (Bedford) — $220,000
  11. Infinity Pharmaceuticals, Inc. (Cambridge) — $540,000
  12. InfraReDx, Inc. (Burlington) — $630,000
  13. Interlace Medical, Inc. (Framingham) — $300,000
  14. Lightlab Imaging, Inc. (Westford) — $188,951
  15. Merrimack Pharmaceuticals, Inc. (Cambridge) — $1,500,000
  16. Morgan Advanced Ceramics, Inc. (New Bedford) — $570,000
  17. NeuroMetrix, Inc. (Waltham) — $300,000
  18. Nova Biomedical Corporation (Waltham) — $300,000
  19. OmniGuide, Inc. (Cambridge) — $540,000
  20. Organogenesis (Canton) — $245,240
  21. Pharmasphere, LLC (Worcester) — $360,000
  22. Sepracor, Inc. (Marlboro) — $750,000
  23. Shire Human Genetic Therapies, Inc. (Lexington) — $6,277,057
  24. STD Med, Inc. (Stoughton) — $121,000
  25. Still River Systems, Inc. (Littleton) — $300,000
  26. TEI Biosciences, Inc. (South Boston) — $27,000
  27. Tolerx, Inc. (Cambridge) — $300,000
  28. Zoll Medical Corporation (Chelmsford) — $267,500

While the tax breaks are a great way to insure that the 28 companies that received them will remain and continue to do business in Massachusetts, creation of only 918 new jobs in exchange for $25 million in tax incentives doesn’t seem fair to me! I guess beggars (state governments) can be chooser in the current economic climate.

Until next time...

Good Luck and Good Job Hunting (try MA, there may be one or two opportunities there)

 

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