Sept. 5 - Senators press RFK Jr., a China deal challenges Bristol and the FDA shifts CRL policy

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo; Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug; Atlas Venture reels in $400M to grow its biotech startups; Drugs from China are reshaping biotech. Track the licensing deals here.

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Daily Dive

Sept. 5, 2025 | Today’s news and insights for biopharma leaders

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Big Pharma Moves in Oncology

Cancer research dominates pharma R&D despite obesity’s rise. Explore AstraZeneca’s long-term strategy in lung cancer and discover where Daiichi Sankyo will go next with ADCs in this Trendline.

At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

Robert F. Kennedy Jr. faced criticism Thursday even from Republicans over changes to federal vaccine policy as well as a leadership crisis at the CDC.

News roundup

FDA to publish CRLs in real time; PEPFAR to distribute Gilead’s Yeztugo

The FDA also unveiled a batch of 89 previously unpublished complete response letters, including rejection notices to Capricor and Replimune.

Bravehart, a stealthy startup, looks to China to challenge Bristol Myers heart drug

Led by the former CEO of Hi-Bio and backed by notable investors, the startup licensed from Hengrui a drug it claims is superior to Bristol Myers' Camzyos as well as other, similar medicines.

Turning aspirational innovations into tangible impacts

Making tomorrow’s breakthroughs a reality for the patients who need therapies today.

Atlas Venture reels in $400M to grow its biotech startups

The venture firm has closed its third "Opportunity Fund,” which complements its early-stage work by supporting startups it's already backed.

UPDATED

Drugs from China are reshaping biotech. Track the licensing deals here.

Hengrui’s licensing deal with Braveheart Bio is the third involving the company and a U.S. or European drugmaker this year, following earlier alliances with Merck & Co. and Merck KGaA.

How to Accelerate Clinical Trial Enrollment

Clinical trial enrollment delays affect 80% of studies, costing sponsors time and money. Learn how centralized recruitment can accelerate enrollment while preserving site autonomy in this playbook.

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