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.

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 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.”

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.

Careful design of a single-use assembly by both the supplier and end user together can mitigate risks and create fitness for the intended use.

Tom Tappen, who passed away Jan. 1, 2015, is remembered for contributions to the pharma industry, customers, and business associates.

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board. The Pharma & Biopharma Outsourcing Association (PBOA) has announced that Nelson Patterson, vice-president, sales and marketing at Baxter BioPharma Solutions, has been elected to its Board of Trustees, effective immediately. Patterson was elected after Baxter BioPharma Solutions joined the PBOA as a Sustaining Member.