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Today’s Big News

Feb 24, 2025

Regeneron gene therapy improves hearing in 10 children with rare form of hearing loss

Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4

FDA works to reverse layoffs, rehire lost staff: reports

Ex-CDER chief Patrizia Cavazzoni becomes Pfizer’s chief medical officer

In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings

FDA approves Medtronic’s adaptive deep-brain stimulator for Parkinson’s disease

Deputy director of FDA's CBER departs amid mass exodus at federal health agencies

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Regeneron gene therapy improves hearing in 10 children with rare form of hearing loss

By Gabrielle Masson

Regeneron’s investigational gene therapy has been tied to notable hearing improvements in 10 of 11 children who were treated for a rare genetic condition that causes hearing loss.

Eli Lilly, Novo Nordisk lead revenue boom in the 'always tricky' Q4

By Kevin Dunleavy

Revenues in the biopharma industry continued to boom in the fourth quarter of last year, following a pattern seen increasingly throughout 2024. Of the world’s 22 biopharma companies that have reported quarterly revenues of at least $2 billion, only one posted a year-over-year decline. And that decline came with a caveat.

FDA works to reverse layoffs, rehire lost staff: reports

By Conor Hale

After hundreds of FDA employees were suddenly laid off last weekend, including dozens at the agency’s device center, the government has begun rescinding some of those cuts and attempting to rehire lost workers.

Ex-CDER chief Patrizia Cavazzoni becomes Pfizer’s chief medical officer

By Gabrielle Masson

After leaving the FDA, where she served as director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., is returning to her previous employer: Big Pharma Pfizer.

In letter to RFK Jr., Democrats flag threats to drug review process from FDA firings

By Zoey Becker

HHS secretary Robert F. Kennedy Jr. has been on the receiving end of two heated letters from lawmakers outlining the threats to innovation posed by mass firings at U.S. health agencies.

FDA approves Medtronic’s adaptive deep-brain stimulator for Parkinson’s disease

By Conor Hale

The company said its U.S. rollout represents the largest-ever commercial launch of a brain-computer interface technology, with Medtronic’s BrainSense platform reading changes in a patient’s neural activity in real-time and then adjusting therapy to suit.

Deputy director of FDA's CBER departs amid mass exodus at federal health agencies

By Darren Incorvaia

Celia Witten, M.D., Ph.D., is no longer deputy director of the FDA’s Center for Biologics Evaluation and Research, joining a long list of health agency leaders who have departed since President Donald Trump began his second term in office.

Lilly banks stockpile of oral GLP-1 drug with potential launch still more than a year away

By Fraiser Kansteiner

Looking to avoid a repeat of the shortages that plagued Mounjaro and Zepbound during their initial rollouts, Eli Lilly is building supply of its oral GLP-1 contender orforglipron well before the drug’s expected approval in 2026.

Liver transplant specialist OrganOx raises $142M for tissue support system

By Conor Hale

The company said its approach has helped cut the number of discarded livers in half compared to simple cold storage.

Sanofi shows how $500M bowel disease bet compares to Merck and Roche's rival assets

By Nick Paul Taylor

Sanofi has shared a deeper dive into its 469 million euro bowel disease bet, publishing phase 2 data that provide a clearer look at how the Teva-partnered prospect compares to Merck & Co. and Roche’s rival candidates.

Regulatory tracker: Gilead's twice-yearly PrEP injection enters accelerated EU review

By Fraiser Kansteiner,Eric Sagonowsky,Angus Liu,Zoey Becker,Kevin Dunleavy

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

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