Articles by Patricia Van Arnum - BioPharm International

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Articles by Patricia Van Arnum

Elan Board Rejects Multibillion Takeover Bid from Royalty Pharma

Elan urges its shareholders to reject bid in an upcoming meeting on June 17.
Jun 11, 2013

Elan urges its shareholders to reject bid in an upcoming meeting on June 17.

Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
Jun 5, 2013

The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.

FDA Issues Draft Guidance on Contract Manufacturing

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.
May 28, 2013

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

FDA Issues Warning Letter to Boehringer Ingelheim for cGMP Violations

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
May 28, 2013

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.

Bristol-Myers Squibb Plans Expansion of Massachusetts Biologics Facility

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.
Apr 12, 2013

The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.

Pfizer Issued Warning Letter for Italian Manufacturing Plant

Company is notified of GMP violations at facility in Catania, Italy.
Apr 11, 2013

Company is notified of GMP violations at facility in Catania, Italy.

State Legislatures Become Battlegrounds for Biosimilars

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.
Apr 11, 2013

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products.

Eli Lilly Considers Investment in US Insulin-Manufacturing Capacity

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.
Apr 8, 2013

Company considers investment in insulin cartridge-filling and insulin API manufacturing capacity in the US.

Pfizer Voluntarily Recalls Levoxyl

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.
Apr 8, 2013

Company issues voluntary recall after learning of complaints of an uncharacteristic odor coming from Levoxyl bottles.

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