June 6 - Gene therapy angst, the FDA’s AI experiment and Otsuka answers Vera

FDA’s AI tool ‘Elsa’ is here, and the industry has questions; Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update; The Trump administration is remaking HHS. Track the changes here.; Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

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Daily Dive

June 6, 2025 | Today’s news and insights for biopharma leaders

TRENDLINE

Inside Oncology’s Research Boom

Since 2015, the FDA’s main drug review office has approved more than ten dozen new cancer drugs. Learn how cancer research is advancing and how it’s changing the industry in the process in this Trendline.

FDA meeting gives window into gene therapy field’s angst

Gene therapy experts and advocates warning of the sector’s many challenges found a receptive audience in FDA leadership at a regulatory forum Thursday.

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's rollout.

News roundup

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

Sponsored Content by Cullinan Therapeutics

A vision for the future of lung cancer treatment

Precision medicine for lung cancer has evolved. But what about mutations that resist treatment?

UPDATED

The Trump administration is remaking HHS. Track the changes here.

The NIH unveiled a plan to guide AI research funding, while FDA documents provided insight on the follow-up study Moderna must run on its newly approved COVID vaccine.

ASCO2025

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

Enhertu, Datroway and other antibody-drug conjugates developed by Daiichi Sankyo have made the company a leader in a competitive field. Hiroyuki Okuzawa is working to keep it that way.

5 Winning Digital Strategies to Support a New Drug

Tomorrow’s most effective treatments will likely combine conventional medications and digital apps. Learn how pharma leaders are already improving access, adherence and engagement in this playbook.

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