BioPharm International Editors

FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.

PDA is conducting a survey of industry members challenged by the complexity of making post-approval changes.

DuPont received a grant from the Bill & Melinda Gates Foundation to produce pharmaceutical proteins.

BMS changes its US geographic footprint with R&D investments and closures.

Spark Therapeutics and Selecta entered a license agreement for Selecta’s gene-therapy co-administration technology.

Through a license agreement with the Broad Institute, Charles River Laboratories will now be offering gene-editing engineering technology.

Takeda and Lightstone have launched Cerevance, a neuroscience company focused on developing therapeutics for neurological and psychiatric disorders.

JHL Biotech and Sanofi collaborate on the development and commercialization of biological therapeutics in China.

QuintilesIMS forecasts global spending on medicine will reach $1.5 trillion by 2021.

Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.

Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.

The UK’s NICE recommended pembrolizumab for the treatment of patients with advanced lung cancer, reversing the institute’s earlier decision.

Boehringer Ingelheim and China Southeast University announced a joint research collaboration to develop new regenerative treatments for hearing loss.

The company opened a new facility in Dublin for its cell performance technology.

Vetter’s Ravensburg data processing center received certification from a German industrial testing organization, certifying that the company’s customer and process data are protected.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

The commission approved future plans, appointed members, and adopted texts during its November 2016 session.

Wockhardt Limited received a warning letter from FDA for CGMP violations.

FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations

EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.

The company plans to expand access to its Prevanar 13 vaccine in humanitarian emergency settings.

STEERLife and the University of Mississippi will collaborate on fractional lobe processing research.

CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.

Neovacs acquired Amegabiotech’s Interferon Alpha manufacturing license for the manufacture of its lead therapeutic candidate.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.

At ICH’s November 2016 meeting, the council announced new members and new guidelines.

Research by agency scientists may help speed development of Zika virus vaccines.