Pharmaceutical Technology Editors

PSL will demonstrate its filtration and drying units, the GFD Lab Filter Dryer, and the SimpleFilter Dryer.

Aesica announced that it received continuing approvals from FDA for its bulk manufacturing and packaging operations in Germany.

The Shantha facility will be Sanofi's second, in addition to its site in Frankfurt, for production of Insuman insulin.

InformEx 2015, to be held Feb. 3-5, 2015 in New Orleans, Louisiana, will feature speaker sessions on the future of the biopharma industry, facility safety, emerging markets, pharmaceutical manufacturing, and more.

CPhI Worldwide partners with InformEx to introduce the cGMP Zone, a dedicated zone for pharma buyers to connect to cGMP CRO/CMO services, intermediates, APIs, and process chemical technologies.

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.

AstraZeneca and the University of Texas MD Anderson Cancer Center announced a plan to collaborate for the improvement of patient outcomes in clinical trials with investigational therapies.

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

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

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.

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.”

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

BASF announced that it would invest $65 million to improve its PVP manufacturing facilities, as well as add production to its Shanghai facility.

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

The decision came as a result of an inspection that raised concerns on how GVK carried out those studies at the Hyderabad site on behalf of marketing authorization holders.