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Blogging from BIO 4 - “It’s a Good Time to be Irish…”

My mother is 100% Irish. Her children, 50%. "Don't forget your heritage even though I was forced to give you an Italian last name," she would say hoping she would not have to insert an IV of soda bread...

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Blogging from BIO 7 - An American in Genzyme

I was fortunate enough to be invited to a private meet and greet with Genzyme CEO, Henri Termeer and taken on a plant tour of the company's new Allston facility. What I had not expected was that I...

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Blogging from BIO 10 – Balance Efficiency and Innovation, Says Genentech’s...

While it may seem that pharmaceutical manufacturers are bitter enemies on the competitive battleground, as it turns out most of them have the same problems and concerns and are willing to help one...

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Gene Therapy Suffers Setback

Reuters reported this week that a patient who became ill following two experimental gene therapy injections for arthritis has died. U.S. health regulators are investigating the cause, officials said...

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BIO 2008: Doing Well by Doing Good: Can Venture Capital Improve Drug...

On Tuesday afternoon, a panel discussed ways in which corporations might be able to stimulate the development of more therapies for serious diseases----the world’s top killers such as malaria. The...

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Genzyme Stockholders Vote on Drug Manufacturing's Strategic Importance

Every so often, one gets a major reminder of the strategic importance of manufacturing and the largely invisible "CGMP set" to the drug industry and, yes, its bottom line. Former FDA chief Mark...

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FDA Releases Details of Manufacturing Issues at Genzyme Allston

Genzyme Corp. has had numerous regulatory problems at its Allston,  Mass. Facility of late—viral contamination issues last summer, and recently FDA warnings and production shutdowns related to metal...

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Genzyme Reported to be Likely to Enter into Consent Decree With FDA

Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action.  Here, reporting from Wall Street...

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At BPI, Some Straight Talk About Single-Use Bioprocess Equipment

As one might expect, single-use bioprocessing equipment was in the spotlight at Bioprocess International's annual meeting in Long Beach, California, last week.  Vendors introduced new or improved...

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