News

Eli Lilly and Incyte face a roughly 18-month application delay for rheumatoid arthritis drug, baricitinib, in the US with a request from FDA for additional clinical data.

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

STA will provide supplies of certain starting and intermediate materials for Tesaro’s recently launched Zejula (niraparib), an orally active and potent poly(ADP-ribose) polymerase inhibitor approved by FDA for the treatment of ovarian cancer. 

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.

JLL ranks top 10 US life-sciences locations where scientists prefer to work and finds that location and workplace culture are key priorities.

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

The agency will lead an international team to create a Supply Chain Security Toolkit of resources to educate the pharmaceutical and healthcare industries on supply chain vulnerabilities.

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Updated ISPE guidance offers risk assessment guidance to avoid cross contamination in multiproduct pharmaceutical manufacturing facilities.

A Merck, Pfizer, and Corning collaboration resulted in development of Corning Valor Glass for improved drug storage and delivery and will create US jobs.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

The new system will help accelerate the commercialization of Aston Particle Technologies’ dry particle coating technology.

The new label-free method for quantifying intracellular bioavailability can be used to predict drug exposure to target cells and hence its efficacy.

The new center will help biopharmaceutical and pharmaceutical manufacturers with product development.

ChargePoint Technology is expanding its US presence by opening a new office in San Francisco.

GSK plans to invest in several UK manufacturing sites and to close its Slough site in conjunction with the sale of the Horlicks brand manufactured in Slough.

Intertek seeks to bring cost efficiencies to the pharmaceutical supply chain through confidential shared audits.

Catalent expands the scope of the OptiForm Solution Suite to bridge gap from late-stage discovery to Phase I trials.

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Alcami will move its headquarters to Durham, NC while maintaining its manufacturing and laboratory operations in Wilmington, NC.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

The agency cited the Italian company for aseptic processing failures.

The National Academies of Sciences, Engineering, and Medicine released a report on its findings on the opioid abuse epidemic, citing the need for a prescribing culture change.

GSK plans to deliver up to 40 million doses of its quadrivalent flu vaccine for the 2017–2018 season.

Higher-flow peristaltic pumps from Watson-Marlow Fluid Technology Group are designed for upstream and downstream bioprocessing with single-use fluid path assemblies.

Gerresheimer’s glass and plastic prefillable syringes will come with an innovative, integrated, passive syringe safety solution, acquired through an exclusive licence from West Pharmaceutical Services.