October 21, 2025

The need-to-know this morning

Galapagos, the troubled Belgian biotech company, said it will now wind down the operations of its cell therapy business after efforts to find a buyer were unsuccessful.

REGULATION

FDA turmoil seen as contributing to slower approvals

The Food and Drug Administration's ongoing turmoil appears to be beginning to ripple through the pharmaceutical industry, STAT's Ed Silverman writes.

New data from RBC Capital Markets show a drop in drug approvals and a rise in rejections and review delays. In the third quarter, the agency approved just 73% of applications — down from an 87% average across the prior six quarters — while rejections climbed to 15% and missed review deadlines nearly tripled.

The RBC analysts attribute the slowdown to mass layoffs, leadership turnover, and the partial government shutdown that's sidelined 14% of the agency's workforce and halted new submissions.

cancer

Merck, with Keytruda and ADC data, steals the ESMO show

Merck dominated this year's European Society for Medical Oncology meeting, earning spontaneous applause for striking Keytruda results in bladder and ovarian cancer and fresh buzz for its next-generation antibody-drug conjugates. The data underscored the company's current status: that of a stalwart still expanding the reach of its $29.5 billion-a-year juggernaut while racing to fill the looming post-Keytruda void.

Analysts said the ADCs — including the Trop2-targeting sac-TMT, which showed strong lung cancer outcomes in a China-led trial — may prove critical to sustaining Merck's oncology momentum. Merck has a busy pipeline of 60 late-stage studies and a strategy blending old successes with new bets to keep investors, and oncologists, cheering. As for experimental Merck drugs targeting Trop2, the company's bullish that its prospects outpace competitors with the same approach.

"It's like saying you're driving a car, and you could be driving a 1974 Honda whatever, or you could be driving a Ferrari," Marjorie Green, Merck's global head of oncology clinical development, said at the conference. "They're different, they have different flavors to them."

cancer

Amgen fills in some gaps on gastric cancer drug

Amgen's gastric cancer drug bemarituzumab was seen as having lost some momentum after the release of a follow-up analysis last month that showed its survival benefit had shrunk, leading to questions about why.

At the ESMO meeting, the company sought to provide some answers.

Initial results from a Phase 3 trial suggested the drug cut the risk of death by 39%, extending median survival to nearly 18 months versus 12.5 for chemo alone. But by June, that advantage had largely evaporated — 14.5 months versus 13.2 — and was no longer statistically significant. Eye-related side effects, including corneal damage and vision loss, occurred in 60% of treated patients.

Amgen said most vision problems had improved and is investigating the diminished benefit while awaiting results from a second large study, STAT's Andrew Joseph writes.

REGULATION

Hiring and drug review slowdown at the FDA

From my colleague Lizzy Lawrence: STAT built a tracker to keep up with the number of senior departures at FDA, but the agency quietly released its own numbers on retention and attrition on Thursday, as first pointed out by AgencyIQ.

The Centers for Drug and Biologics Evaluation and Research have both lost a tremendous number of people compared to previous years. In the fiscal year 2025, CDER lost 1,093 people and CBER lost 224. In comparison, CDER gained 259 people and CBER gained 105 in fiscal year 2024.

Stakeholders continue to worry that brain drain at the FDA will impact its work.

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