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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

‘Dangling’ Accelerated Approval Reviews Expand At US FDA

The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.

Advisory Committees Cancer

US FDA’s October Outlook Includes Psoriasis Blockbuster Hopeful, Ophthalmology And Orphans

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.

Drug Review Advisory Committees

340B Exemptions Offer Manufacturers ‘Significant’ Incentives To Seek Orphan Status – HHS OIG

Office of Inspector General report explores the orphan drug status of a set of blockbuster drugs with the highest level of spending in Medicare.

Reimbursement Medicare

Picture Is Worth 1,000 Meetings: ‘Snapshots’ Could Support ‘Breakthrough’ Dialogue At US FDA

US FDA’s Oncology Center of Excellence is eager to pilot test ‘Drug Development Snapshots’ as a potential tool to optimize communication for drugs receiving the Breakthrough Therapy Designation. That may be an early next step in the effort to enhance the expedited pathway.

Review Pathway Drug Approval Standards
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