Roche’s Columvi expansion bid hits wall

Today’s Big News

May 20, 2025

FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach


Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, Merck


Roche’s Columvi expansion bid in danger as FDA’s Makary, Pazdur push for more US enrollment in cancer trials


Nominations now open for Fierce Biotech's 2025 Fierce 15


Philips to test ultra-low dose X-ray technique in cath lab study


Schrödinger lays off 60 staffers amid ‘uncertain times and challenging economic conditions’


All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma

 

Featured

FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach

FDA Commissioner Marty Makary, M.D., and CBER head Vinay Prasad, M.D., detailed their new approach to COVID vaccines in a Tuesday update. The agency leaders say they're pursuing an "evidence-based approach to COVID-19 vaccination."
 

Top Stories

Pfizer pays 3SBio $1.25B for PD-1xVEGF bispecific, joining red-hot race with BioNTech, Merck

Pfizer has joined the PD-1xVEGF bispecific gold rush. The Big Pharma is paying 3SBio $1.25 billion upfront for ex-China rights to a clinical candidate, establishing itself as a challenger to BioNTech, Merck & Co. and Summit Therapeutics in a scorching-hot area of immuno-oncology.

Roche's Columvi expansion bid in danger as FDA's Martin Makary, Richard Pazdur push for more US enrollment in cancer trials

Roche looks unlikely to be able to move its DLBCL drug Columvi earlier in the treatment sequence after experts on an FDA advisory committee joined the agency in questioning the regional imbalance of clinical trial data. What's more, both FDA Commissioner Martin Makary, M.D., and longtime FDA oncology chief Richard Pazdur, M.D., have a new message for drug developers.

Nominations now open for Fierce Biotech's 2025 Fierce 15

Fierce 15 nominations are open! We're searching for the most innovative, resourceful and visionary biotechs leading the way through the industry's mercurial conditions.

Philips to test ultra-low dose X-ray technique in cath lab study

The trial will aim to reduce X-ray exposure by 50% over the lowest-available setting on Philips’ Azurion image-guided therapy systems.

Schrödinger lays off 60 staffers amid ‘uncertain times and challenging economic conditions’

Schrödinger is laying off 60 staffers, or about 7% of its workforce, in an effort to save cash and boost efficiency.

All branded drugs not facing generic, biosimilar competition must abide by MFN order in 'all markets,' HHS tells pharma

President Donald Trump's recent Executive Order on drug prices applies to "all brand products across all markets that do not currently have generic or biosimilar competition," the HHS said in a Tuesday press release.

ViiV Healthcare retakes first place in pharma reputation ranking among US patient groups

Fresh off taking the top spot in an annual survey of how patient groups around the world view major drugmakers, ViiV Healthcare has clinched the No. 1 slot in a U.S.-specific version of the survey, too.

SV Health’s latest pharma-backed dementia fund raises $269M to invest in new therapies

A dementia-focused transatlantic venture capital initiative has secured $269 million in commitments for its second fund.

As Eli Lilly outperforms Novo in market, it also replaces its rival in annual IDEA Innovation rankings

As Eli Lilly and Novo Nordisk continue to go in opposite directions in their diabetes and obesity market rivalry, so too have they changed positions in the annual IDEA Pharma Innovation Index. Lilly advanced from fourth place in 2024 to the top spot this year, supplanting 2024 champion Novo.

SK Life Science starts TV ad campaign to drive patients to seizure drug Xcopri

SK Life Science is encouraging patients beetling down the long and winding road toward seizure-free life to switch gears. In a new nationwide direct-to-consumer ad, the Xcopri manufacturer asks partial-onset seizure patients to consider switching to a new treatment.

J&J study examines Shockwave-first strategy in women with blocked coronary arteries

The trial tested Shockwave Medical's vessel-clearing approach as the primary procedure for women with hardened, calcified blockages in the heart’s coronary arteries.

Doctors want more educational, financial info from pharmas: report

Drugmakers looking to broaden their appeal among healthcare professionals can forgo flashy gimmicks and lavish freebies—what doctors really want, according to a new report, is access to practical, helpful information.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': A Fierce breakdown of the 'most favored nation' executive order

This week on "The Top Line," Fierce Pharma breaks down President Donald Trump’s executive order targeting drug prices and what it could mean for the industry as broader policy shifts unfold.

 

Resources

Whitepaper

Accelerating Clinical Trial Excellence: A Seamless IRB & IBC Collaboration

Don’t delay your gene transfer trial’s start-up timeline by gaining the latest insights from WCG’s case study on the power of a seamless Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) review process.
Whitepaper

SpyLock Technology: A cutting-Edge Solution for Rapid Bispecific Antibody Screening

Learn how the SpyLock service can offer fast bispecific generation, reduce workload, and accelerate candidate selection.
Whitepaper

Best Practice Medical Affairs Organization Study Report

We interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned.
 

Upcoming Fierce Events

8-11
Sep
Philadelphia, PA
10
Sep
Philadelphia, PA
7-9
Oct
Boston, MA
12-13
Nov
Free Virtual Event
20
Nov
The Lighthouse at Pier 61 in New York City

View all events