The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.

New therapies and tighter budgets challenge bio/pharma to think outside the industry.

Nik Leist’s keynote address will explore the manufacturing of digital medicines at the CPhI North America 2018 conference in Philadelphia, PA, on Wednesday, April 25, 2018.

Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.

Industry analyst Jim Miller will provide insight into the past, present, and future of the contract services market at the CPhI North America conference on Wednesday, April 25, 2018 in Philadelphia, PA.

The new premises have been built-to-spec to offer efficient, high quality, and environmentally friendly service to customers.

The contract research organization has added a new analytical laboratory in Middleton, WI, to expand its biologics testing capacity.

The company’s close communication with customers has enabled it to bring advanced pipetting products to market.

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.

The acquisition strengthens Celgene’s position in the global cellular immunotherapy space.

The companies will co-develop and co-promote a CAR T cell therapy in the United States.

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.

Takeda is considering approaching Shire with a possible offer.

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.

Natoli acquired Carlisle Precision Machining, which supplies replacement parts for encapsulation equipment.

Gyros Protein Technologies’ new immunoassay technology includes expanded software to optimize time to results and sample capacity while simplifying workflows.

Telstar reports that its Boreas, a new 86° ultra-low-temperature freezer, increases average performance by 20%.

In a $13-billion transaction, GSK will purchase Novartis’ share of the Consumer Healthcare Joint Venture.

Cleanroom floor and wall solutions from Sika meet rigorous standards for pharmaceutical manufacturing facilities.

MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The collaboration between the two companies aims to finish all necessary work needed to file for a first-in-human study by early 2019.