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Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Medicare’s Final Coverage Decision On Alzheimer’s Drugs: Thoughts From A Former CMS Chief

Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.

Medicare Reimbursement

Pink Sheet Podcast: Makena Withdrawal Hearing, Califf And Trust In FDA, COVID-19 Pill Dispensing

Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.

Drug Approval Standards Coronavirus COVID-19

ViCentra Believes Smaller Is Better For Insulin Pumps

Medtech Insight spoke to the manufacturers of the smallest commercially available insulin pump to learn more about how it works, the market factors impacting it, and how scaling up a business can throw up unexpected challenges.

Diabetic Care Digital Health

Avastin Withdrawal Showed Accelerated Approval Hearing Process No Easy Task For US FDA

Internal emails show the 2011 hearing on Genentech’s VEGF-inhibitor was taxing for FDA employees, who had to deal with a number of novel issues; the workload is likely to be similarly complex for staff involved in upcoming hearing on Covis’ preterm birth prevention drug Makena.

Pink Sheet Perspectives Review Pathway
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