Annual growth in spending for medicines is expected to rise from 2-3% in 2013 to 5-7% in 2017, the highest pace of growth since 2009.
AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.
The move follows rejection of Elan shareholders of certain key deals and withdrawal of Royalty Pharma bid.
Elan urges its shareholders to reject bid in an upcoming meeting on June 17.
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished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.
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
The company expands to add process-development and clinical-manufacturing capabilities at its large-scale bulk biologics facility.
Company is notified of GMP violations at facility in Catania, Italy.