FDA marketing overseers resign: report

Today’s Big News

Apr 21, 2025

The top 20 pharma companies by 2024 revenue


As Harvard battle escalates, HHS directs NIH not to tell universities about new grant freezes: reports


Top leaders at FDA marketing overseer resign, potentially teeing up RFK Jr.’s promised drug ad ban: report


Tempest Therapeutics lays off 80% of workforce to ride out cash crunch


Medtronic nets FDA approval to pair Simplera Sync CGM with MiniMed 780G


AstraZeneca, Daiichi say Enhertu delivers 'highly statistically significant' efficacy in first-line breast cancer


Immunovant narrows R&D focus as Roivant execs take CEO, CFO posts

 

Featured

The top 20 pharma companies by 2024 revenue

Revenues boomed for the top 20 companies in the biopharma industry in 2024, with only one company (Bayer) seeing a revenue decline last year. Six drugmakers saw their sales rise by double-digit percentages, led by Eli Lilly (32%) and Novo Nordisk (26%).
 

Top Stories

As Harvard battle escalates, HHS directs NIH not to tell universities about new grant freezes: reports

The National Institutes of Health (NIH) is halting new grant and contract payments to several universities, a move the agency has been instructed not to disclose to the affected schools, according to several reports.

Top leaders at FDA marketing overseer resign, potentially teeing up RFK Jr.’s promised drug ad ban: report

OPDP director Catherine Gray and deputy director Mark Askine told staffers on Thursday that they were leaving, and their resignations took effect Friday, Politico’s AgencyIQ reports, citing emails shared by sources within the office.

Tempest lays off 80% of workforce to ride out cash crunch

Tempest Therapeutics is hunkering down to weather the storm that has engulfed its operations. Days after starting to look for partners, the company has moved to lay off 21 of its 26 full-time employees to stretch its limited cash reserves.

Medtronic nets FDA approval to pair Simplera Sync CGM with MiniMed 780G

Medtronic has secured a green light from the FDA to connect its latest automated insulin pump with its newest continuous glucose monitor, following a similar approval for the pairing in Europe early last year.

AstraZeneca, Daiichi say Enhertu delivers 'highly statistically significant' efficacy in first-line breast cancer

AstraZeneca and Daiichi Sankyo are aiming to establish their star antibody-drug conjugate Enhertu as a first-line treatment in HER2-positive breast cancer after recording “highly statistically significant” efficacy in a key trial.

Immunovant narrows R&D focus as Roivant execs take CEO, CFO posts

Roivant is putting its people at the top of Immunovant—and they have made an immediate mark on the biotech’s pipeline. Having previously planned to target 10 indications, the biotech has narrowed its focus to six settings where it could start delivering potentially registrational data in 2027.

Gilead's Trodelvy-Keytruda proposal hits goal in first-line triple-negative breast cancer

In the first phase 3 trial to show the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in first-line triple-negative breast cancer, Gilead Sciences’ Trodelvy has notched a much-needed win.

Brexit-related costs leave UK cancer patients, research in jeopardy: report

Extra costs and red tape from the U.K.'s split from the European Union have slowed down cancer research in the U.K. and left some patients without lifesaving treatment, a new report obtained by the Guardian reveals.

FDA rejection of extended dosing interval is another piece of bad news for Regeneron’s Eylea HD

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea from a maximum frequency of every 16 weeks to every 24 weeks. The rejection is another blow for Regeneron, which is losing market share to Roche and its eye disease treatment Vabysmo.

Inside Phathom's 'lighthearted' approach to Voquezna marketing, from cheeky tagline to 'SNL' spokes-celeb

In a commercial debuting Monday, Kenan Thompson hosts the “Kick Some Acid Cooking Show,” serving up a gourmet meal with over-the-top flair while he discusses how Phathom’s Voquezna helps reduce heartburn associated with his non-erosive GERD.

Sanofi, Regeneron score their 7th indication for Dupixent with FDA nod to treat hives condition

Sanofi and Regeneron have scored an FDA approval for Dupixent in its seventh indication—chronic spontaneous urticaria (CSU). The nod comes 18 months after the U.S. regulator rejected Dupixent in the same indication.
 
Fierce podcasts

Don’t miss an episode

Navigating Trump’s tariffs for pharma

This week on “The Top Line,” we unpack the latest tariffs from the Trump administration and their potential impact on the life sciences industry.
 

Resources

eBook

Through a CRO's perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing

Typical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic.
Whitepaper

Protect Your Trial Data: Endpoint, Imaging, and Safety Review

Is your clinical trial data truly reliable? Learn how a combined approach using Imaging Core Labs and Endpoint Adjudication Committees (EAC) can minimize risk, control costs, and strengthen your study from the ground up. Don’t leave success to chance—arm yourself with the insights to stay ahead.
Research

Best Practice Customer-Facing Organization Study Report

We interviewed 15 biopharma leaders on the critical success factors for building a Best Practice customer-facing organization. This report shares what we learned.
 

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