Gauging Investment in High-Potency Manufacturing
Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.

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Evaluating Risk-Based Specifications for Pharmaceuticals
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.

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Evaluating Parenteral Packaging for Glass Delamination
A screening method predicts delamination in primary packaging.

FDA Issues Warning Letter after Re-inspection of AMRI Burlington Facility
AMRI is currently preparing a complete response to the FDA's 2013 Form 483 with all corrective actions addressed and implemented.

Life Technologies Stockholders to Meeting on Thermo Fisher Scientific Acquisition
Life Technologies Corporation has filed a definitive proxy statement with the US Securities and Exchange Commission regarding Thermo Fisher Scientific Inc.

Galectin Therapeutics Submits Fast Track Application
Galectin Therapeutics has submitted a Fast Track application to the FDA to help expedite its clinical development program of GR-MD-02 in the treatment of fatty liver disease.

Denaro Named General Manager Aptuit Discovery Center
Aptuit has announced that Maurizio Denaro has assumed responsibilities as general manager of The Aptuit Center for Discovery & Development in Verona, Italy.

Immunocore Signs Research and Licensing Agreement with GSK
Immunocore Limited has entered into a partnership with GlaxoSmithKline for multiple novel targets not addressable using antibody-based technologies.

Zeiss Acquires Xradia
Zeiss announced the acquisition of Xradia, Inc.

Patients, Physicians Support Transdermal Drug Delivery
A new end-user survey of more than 220 physicians and 650 patients by Frost & Sullivan finds that regardless of disease area, physicians select drug delivery methods that drive consistent patient compliance and effective outcomes.

Genentech's Obinutuzumab Gets Priority Review
Genentech announced that the FDA has accepted the company's Biologics License Application for obinutuzumab (GA101) in the treatment of chronic lymphocytic leukemia (CLL).

New Clinical Trial Partners to Expand Laboratory Sciences Clinical Sample Analysis Groups
Charles River has established partnerships with Target Health Inc. and Theorem Clinical Research Inc.

Breathing New Life Into Old Drugs
Acquisition database helps extend product lifecycle by seeking new applications for drugs.