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Bayer US head says FDA chief reassured pharma executives of timely reviews
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Bayer US head says FDA chief reassured pharma executives of timely reviews
May 26, 2025 9:10 AM

By Bhanvi Satija and Michael Erman

NEW YORK, May 15 (Reuters) - Bayer

Pharmaceuticals' chief operating officer said the head of the

top U.S. drug regulator recently reassured industry executives

that the Food and Drug Administration would meet its targets for

reviews despite recent job cuts and a restructuring.

"We're looking at an FDA and scientific review staff that is

stable, engaged and meeting its deadlines," Sebastian Guth, who

oversees Bayer's U.S. operations, said in an interview.

Guth said that after a recent meeting between FDA

Commissioner Marty Makary and industry executives, he was

confident that the leadership wanted to maintain the agency's

standards. Makary said last month the FDA will meet its targets

for completing reviews of new drugs despite mass firings under

the Trump administration.

Reuters had reported in early April that firings at the FDA

included employees critical to reviewing new medicines.

"I heard an FDA commissioner who notes and acknowledged that

the industry requires a stable and predictable regulatory

environment," said Guth, adding that Makary underlined his

intent to use technology to support FDA's work.

The FDA is expected to decide whether to expand approval

for Bayer's kidney disease drug Kerendia to patients with heart

disease this year.

Guth said Bayer's interactions with the FDA, predominantly

its Center for Drug Evaluation and Research, had followed tight

protocol and the agency had met its deadlines for experimental

drugs under review.

"We've seen the FDA responding within the timelines that are

to be expected," he said.

Bayer's experimental drug, elinzanetant, for treating

menopause symptoms, is also under review.

Guth said Bayer's first-quarter sales growth in the U.S., a

key market, exceeded the 23% rise for North America reported

earlier this week. Bayer does not break out sales by country.

The U.S. accounted for a "significant chunk" of its sales of

new prostate cancer drug Nubeqa and kidney treatment Kerendia,

he said. On Tuesday, the company reported a combined 680 million

euros ($760.51 million) in revenues from both drugs.

($1 = 0.8941 euros)

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