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GSK Opens Global Vaccines R&D Center in Maryland
GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.
PDA Asks for Input on CMC Post-Approval Changes
PDA is conducting a survey of industry members challenged by the complexity of making post-approval changes.
DuPont Receives Grant from Bill & Melinda Gates Foundation
DuPont received a grant from the Bill & Melinda Gates Foundation to produce pharmaceutical proteins.
Bristol-Myers Squibb Announces US Investments and Closures
BMS changes its US geographic footprint with R&D investments and closures.
Something for Everyone in “Cures” Package
Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.
Spark Licenses Selecta’s Gene-Therapy Administration Technology
Spark Therapeutics and Selecta entered a license agreement for Selecta’s gene-therapy co-administration technology.
Novartis, Kite Release Positive CAR-T Data
At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.
Charles River to Offer CRISPR/Cas9 Genome Editing
Through a license agreement with the Broad Institute, Charles River Laboratories will now be offering gene-editing engineering technology.
Takeda and Lightstone Ventures Launch Cerevance
Takeda and Lightstone have launched Cerevance, a neuroscience company focused on developing therapeutics for neurological and psychiatric disorders.
Sanofi, JHL Biotech Launch Biologics Alliance in China
JHL Biotech and Sanofi collaborate on the development and commercialization of biological therapeutics in China.
Global Spending on Medicine Predicted to Reach $1.5 Trillion by 2021
QuintilesIMS forecasts global spending on medicine will reach $1.5 trillion by 2021.
FDA Blog Examines Inspection Expansion in the EU
Dara Corrigan examines the Mutual Reliance Initiative as a method for expanding FDA’s inspection capabilities in Europe and beyond.
Duke Researchers Test PEG-Alternative as a New Drug Delivery Technology
Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.
NICE Recommends Lung Cancer Drug
The UK’s NICE recommended pembrolizumab for the treatment of patients with advanced lung cancer, reversing the institute’s earlier decision.
Boehringer Ingelheim Collaborates with China Southeast University on Hearing Loss
Boehringer Ingelheim and China Southeast University announced a joint research collaboration to develop new regenerative treatments for hearing loss.
Valitacell Opens New Facility at NIBRT
The company opened a new facility in Dublin for its cell performance technology.
Vetter Processing Center Receives Data Certification
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.
House Approves Revised “Cures” Bill
The House-approved 21st Century Cures legislation supports initiatives for medical research, drug development, and faster approvals, but comes up short on actual appropriations.
Takeda Builds Dengue Vaccine Manufacturing Plant in Germany
Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.
European Pharmacopoeia Commission Sets Priorities for Next Three Years
The commission approved future plans, appointed members, and adopted texts during its November 2016 session.
FDA Cites Facility for Aseptic Processing Violations
Wockhardt Limited received a warning letter from FDA for CGMP violations.
Data Integrity Problems Found at Indian Facility
FDA issued a warning letter to Srikem Laboratories Pvt. Ltd. for data integrity violations
Single-Use System Handles Difficult-to-Mix Ingredients
EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.
Don’t Blow Up FDA
Biopharma proponents argue for FDA resources, Cures legislation, and science-based drug regulation.
Pfizer Expands Humanitarian Assistance Program
The company plans to expand access to its Prevanar 13 vaccine in humanitarian emergency settings.
STEERLife Collaborates with the University of Mississippi
STEERLife and the University of Mississippi will collaborate on fractional lobe processing research.
CDER Launches Experiential Learning Program for OPQ Staff
CDER is asking manufacturers to participate in the Experiential Learning Site Visit Program to educate OPQ staff about pharmaceutical manufacturing processes.
Neovacs Acquires Interferon Alpha Manufacturing Technology
Neovacs acquired Amegabiotech’s Interferon Alpha manufacturing license for the manufacture of its lead therapeutic candidate.
Almac Expands Commercial Packaging Facility
The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.
Nitto Avecia Expands Oligonucleotide Manufacturing Capacity
Avecia is adding drug substance capacity at its Milford, MA manufacturing site.
