News

The contract service provider entered into a contract agreement with the US Army to provide services in the development of treatments of malaria.

Portola signed a $50-million loan agreement with BMS and Pfizer to provide additional funding for the development of andexanet alfa.

Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.

The agency put Baoying County Fukang Medical Appliance Co., Ltd. on import alert after observing violations at the company’s Yangzhou City facility.

A pilot project, beginning in 2017, will support the development of biosimilars.

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

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

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

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

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.

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

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

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

IPEC-Americas held elections for executive committee positions at the annual board of trustee’s dinner.

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.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

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

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

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

FDA issued a warning letter to Interquim, SA for CGMP deviations at its Barcelona API facility.

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.

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

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.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.