FDA Issues Import Alert Against Ranbaxy Laboratories
FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India.

FDA Advisory Committee Recommends Approval for GSK and Theravance's COPD Drug
An FDA Committee voted to support approval of GSK and Theravance’s umeclidinium/vilanterol for treatment of chronic pulmonary disease.

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Hospira Voluntarily Recalls Certain Lots of Bupivacaine
FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

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Roche Nominates New Chairman
Roche nominates Christoph Franz, currently CEO of the Lufthansa Group, to succeed current Roche chairman Franz B. Hummer.

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Hovione Receives Patent Approval for XCaps DPI
The device is an inexpensive, easy-to-use capsule-based DPI with high efficiency powder dispersion and has the versatility to treat a range of pulmonary diseases.

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Takeda's Drug Vedolizumab is Granted Priority Review Status by FDA
Takeda's drug vedolizumab is granted priority review status for the treatment of adults with moderately to severely active ulcerative colitis.

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FDA Reissues Bioanalytical Method Validation Guidance
FDA updates guidance to reflect advances in technology.

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First biosimilar mAb approved in Europe
Hospira's Inflectra (infliximab), which is a biosimilar to the reference biologic product, Remicade, has been approved by the EC for the treatment of inflammatory conditions.

European Medicines Agency Reorganizes
EMA releases details of restructuring.

AMRI Announces Executive Leadership Changes
AMRI reported that Thomas E. D'Ambra, PhD, will retire as president and CEO.

EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre
EMD Millipore receives recertification of GMP compliance for its Biodevelopment Centre in Martillac, France.

Meeting Technical and Regulatory Requirements for Organic Impurity Control and Analysis
Product quality is of paramount importance to pharmaceutical manufacturers, and implementing a strategy for impurity control is crucial. Pharmaceutical Technology is holding a live educational webcast on Tuesday Sept. 24 to provide insight on the regulatory, compendial, and ICH requirements for organic impurity control and analysis as well as best practices in analytical method development, method selection, and method validation for detecting and quantifying organic impurities in drug substances and drug products.