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Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

 
• By Jessica Merrill

US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.

US FDA Commissioner Scott Gottlieb used the opening session of the American Society of Oncology annual meeting in Chicago on June 2 as an opportunity to deliver a message that the agency is laser-focused on improving the drug review process to speed new innovations to market.

"There are critics who think that we should hold drugs back from the market, and demand more pre-market studies emphasizing overall survival endpoints before we consider approving new treatments," he said. "I disagree

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Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
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The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

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EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.