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Latest From MacroGenics, Inc.

Workforce Of The Future Initiative Aims To Close Skills Gap In Biopharmaceutical Industry

The biopharmaceutical industry is expanding its presence on college campuses to address a shortage of workers proficient in advanced manufacturing, cell and gene therapies and combination products. Executives say that not having enough of these skilled workers keeps them up at night.

Manufacturing Quality

DESTINY Calls For Daiichi Sankyo/AZ’s Enhertu In Other Indications

Daiichi Sankyo and AstraZeneca’s ambitions to expand the use of their HER-2 targeted antibody-drug conjugate product beyond breast cancer are looking realizable on the back of new results presented at ASCO, but toxicities remain an issue. 

ASCO Clinical Trials

Delayed Advisory Committees Need Not Worry Sponsors Too Much

US FDA advisory committee meetings held in close proximity to user fee goal dates are approved at a similar rate to all products reviewed by the advisory panels, according to a Pink Sheet analysis of drug and biologic advisory committees since 2015.

Advisory Committees Drug Review

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Drug Review Drug Approval Standards
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