News

Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

The agency announces that 81 medicines overall were recommended in 2016.

Lonza adds CDMO, capsule, and consumer healthcare and nutrition capabilities with $5.5-billion acquisition of Capsugel.

The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

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.

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.

Congress enacted the 21st Century Cures legislation, which shores FDA operations and supports biomedical research at the National Institutes of Health.

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

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

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.

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 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.