Articles by Haydia Haniff - BioPharm International

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Articles by Haydia Haniff

Despite Challenges, Biotech Staying Positive, Says Ernst & Young

May 18, 2010

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.

PCV1 Virus Detected in GSK's Rotarix Vaccine

Mar 22, 2010

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.

Contamination at Another Genzyme Manufacturing Plant

Mar 15, 2010

On February 12, Genzyme (Cambridge, MA) notified Cerezyme users of an impurity found in a vial manufactured at its Waterford, Ireland plant.

Baxter Receives Warning Letter from FDA Regarding Gammagard Manufacturing

Mar 10, 2010

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.

FDA Approves Shire's New Gaucher Drug

Mar 2, 2010

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.

Sanofi Pasteur Expands Recall of H1N1 Vaccine

Feb 17, 2010

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.

Phase 1-2 Completed for Universal Influenza Vaccine

Jan 15, 2010

BiondVax Pharmaceuticals Ltd, an Israeli biopharmaceutical company, has completed Phase 1-2 clinical trials of its Multimeric-001 universal flu vaccine.

Shire Files Marketing Applications for Fabry and Gaucher Disease Drugs

Jan 15, 2010

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.

Genzyme Resumes Cerezyme Shipments; Pfizer Licenses Gaucher Treatment

Dec 2, 2009

Genzyme Corporation (Cambridge, MA) has begun shipping vials of newly produced Cerezyme (imiglucerase for injection) manufactured at its plant in Allston Landing, MA.

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