New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

Pharma majors AstraZeneca and Merck & Co. form $8.5-billion partnership to develop cancer therapies revolving around AstraZeneca’s PARP inhibitor, Lynparza.

Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).

The agency is asking public consultation on the concept paper.

Pharma major aims to focus majority of R&D capital into priority therapy areas and plans to cut approximately 30 R&D programs.

Takeda Pharmaceutical partners with US biopharmaceutical company, TESARO, in deal worth up to $340 million to develop and commercialize PARP inhibitor.

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

Corning and Gerresheimer have been working together to accelerate innovations for pharmaceutical glass packaging.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

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.