USP Defers Implementation of Elemental Impurities Provisions
USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.
FDA Issues Draft Guidance on Contract Manufacturing
The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished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.
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 made in its facility in Ingelheim am Rhein, Germany.
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J&J Poised for Growth, 10 New Product Filings Expected by 2017
Johnson & Johnson anticipates submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017.
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Valeant Pharmaceuticals To Acquire Bausch + Lomb
Valeant Pharmaceuticals and Bausch + Lomb have entered into a definitive agreement under which Valeant will acquire Bausch + Lomb for $8.7 billion in cash.
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US Government Signs Deal with GSK to Develop Antibiotics
Partnership will support development of drugs to fight antibiotic resistance and bioterrorism.
Novo Acquires Xellia for US$ 700 Million
Novo A/S, the holding company of Denmark's Novo Nordisk, has acquired Xellia Pharmaceuticals and purchased all shares of the group for approximately US$ 700 million.
Pfizer Halts Phase III Trial of Cancer Drug in NHL Due to Futility
Pfizer has discontinued a Phase III study of its investigational cancer drug, inotuzumab ozogamicin, in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) after it failed to show benefit in overall survival.
Strong INTERPHEX 2013 an Indicator of Industry Regrowth
More than 12,000 industry professionals, including 8,100 show attendees, participated in INTERPHEX 2013, a 20% increase over the 2012 show.
SCHOTT Introduces Cartridge Design for High-Speed Filling
New design meets new process requirements.
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