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What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says

 
• By Cathy Dombrowski and Bridget Silverman

An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.

The conclusion of a recent FDA analysis of new molecular entity approvals that takes into account the true novelty of the drugs – that the level of innovation has been more consistent than raw NME counts suggest – holds up when put to the test of the past couple of years.

The novelty of the 2012 and 2013 new drug approvals is on track to match the stable levels identified by a recent FDA analysis of NME approvals from 1987-2011 – lending further credence to the agency’s argument that the so-called

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• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
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Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
• By Neena Brizmohun

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New EU Filings

 
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Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.