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Dalton to Support US Army Drug Development Program
The contract service provider entered into a contract agreement with the US Army to provide services in the development of treatments of malaria.
Baxter to Acquire Claris Injectables
Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.
Portola Signs Loan Agreement with BMS, Pfizer
Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.
FDA Puts China Firm on Import Alert
The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.
EMA Launches Biosimilars Project
A pilot project, beginning in 2017, will support the development of biosimilars.
Emergent Signs Contract with CDC for Anthrax Vaccine
Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.
Univercells Receives $12-Million Grant to Develop Vaccine Manufacturing Platform
Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.
bluebird bio and apceth Biopharma Enter Manufacturing Agreement
The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.
EMA Recommends Seven Medicines for Authorization
The agency announces that 81 medicines overall were recommended in 2016.
Lonza to Acquire Capsugel
Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.
European Pharmacopoeia Commission Concludes Biotherapeutics Pilot Phase
The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.
Oxford Genetics Receives Grant from Innovate UK
Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.
CDER Prepares for Cures Act
FDA’s Center for Drug Evaluation and Research makes plans for implementation of the 21st Century Cures Act that include patient-focused drug development.
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.