May 18, 2010
By:
Haydia Haniff
Ernst & Young has released its annual report on the state of the biotech industry, Beyond Borders: Global Biotechnology Report 2010, and overall, things are looking good for the industry.
|
Mar 22, 2010
By:
Haydia Haniff
The US Food and Drug Administration is recommending that healthcare practitioners temporarily suspend use of the Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, while the agency learns more about components of an extraneous virus detected in the vaccine.
|
Mar 15, 2010
By:
Haydia Haniff
On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.
|
Mar 10, 2010
By:
Haydia Haniff
On January 15, 2010, Baxter Biosciences (Deerfield, IL) received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMPs) in the manufacture of Gammagard (human immune globulin) liquid and Gammagard S/D intermediates at its manufacturing facility in Lessines, Belgium.
|
Mar 2, 2010
By:
Haydia Haniff
The US Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.
|
Feb 17, 2010
By:
Haydia Haniff
Sanofi Pasteur (Lyon, France) has recalled an additional six lots of its Influenza A (H1N1) 2009 Monovalent Vaccine in prefilled syringes after routine testing found that the antigen content had declined below the specification limit.
|
Jan 15, 2010
By:
Haydia Haniff
Shire plc (Cambridge, MA) has submitted a biologics license application (BLA) with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease.
|
Jan 15, 2010
By:
Haydia Haniff
BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1-2 clinical trials of its Multimeric-001 universal flu vaccine.
|
Dec 2, 2009
By:
Haydia Haniff
Genzyme Corporation (Cambridge, MA) has begun shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at its plant in Allston Landing, MA.
|
|
