EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

Tooling can be damaged by poor handling or problems in process design or material choice.

Initiatives to speed drug development must pass Congress and special interest groups.

Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.

CPhI experts make predictions on pharma trends for 2015.

Bristol-Myers Squibb and Johnson & Johnson announced FDA-approval of Evotaz and Prezcobix, combination HIV-1 infection treatments.

Vetter has announced that the first phase of the expansion of its Ravensburg Schuetzenstrasse site has been completed after 16 months of construction. The company has invested EUR26 million into this facility, which will be equipped with a data center, high-tech laboratories, and workplaces for Vetter Development Service. The new multi-functional six-story building is expected to be ready for operation by the beginning of 2016.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

PPD announced that it completed an expansion to its Athlone, Ireland facility, resulting in 20,000-square-feet of dedicated space for warehousing and distribution purposes.

Recipharm has completed a serialization project for China on behalf of one of its customers.

Industry voices concerns over draft legislation that seeks to get much needed treatments to patients.

FDA has approved the Ash Steven’s manufacturing facility in Riverview, MI for the manufacture of Amotosalen.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

PwC released a report based on surveys completed by consumers and senior industry leaders, which focuses on FDA procedures.

Hovione announced that it appointed a vice-president of R&D to work directly with client drug development projects.

The new facility will feature dry powder cell-culture media capabilities.

The new facility will feature new research and development capabilities.

The company has installed and validated new instruments for structural analysis of proteins.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions. The European Medicines Agency (EMA) has issued a recommendation that 700 medicines authorized for use in the European Union (EU) should be suspended, based on concerns about how GVK Biosciences, a contract research organization in Hyderabad, India, conducted clinical studies. GVK Biosciences, in response, argued “the action is unprecedented and highly disproportional.”