Roche AI lung cancer test nabs breakthrough tag

Today’s Big News

Apr 29, 2025

Regeneron’s Eylea franchise suffers double whammy with sales decline and surprise FDA rejection


Ono Pharma lays off 83 staffers at Cambridge site


Roche receives FDA breakthrough label for AI-powered lung cancer companion diagnostic test


As pharma industry's reputation slips again, ViiV retains top spot among patient groups: survey


Pfizer, in sweeping cost cutting push, lifts overall savings target to $7.7B


Eli Lilly pens Creyon Bio AI oligonucleotide pact with $1B in biobucks on the table


Sequel Med Tech to link Senseonics’ 365-day CGM with upcoming twiist insulin pump

 

Featured

Regeneron's Eylea franchise suffers double whammy with sales decline and surprise FDA rejection

After consecutive setbacks at the FDA, Regeneron's string of recent troubles with its Eylea franchise is continuing to pull down the drugmaker. Aside from a sales slump fueled by a broader downturn in the VEGF medicine market, a crucial prefilled syringe version of the drug's high-dose format was rejected by the FDA last week, Regeneron said in an earnings release.
 

Top Stories

Ono Pharma lays off 83 staffers at Cambridge, Massachusetts, site

The affected Cambridge site is Ono’s U.S. headquarters and one of the company's two locations in the country, with the other in San Francisco.

Roche receives FDA breakthrough label for AI-powered lung cancer companion diagnostic test

Roche’s companion diagnostic aims to identify non-small cell lung cancer patients who may benefit from Datroway, an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo.

As pharma industry's reputation slips again, ViiV retains top spot among patient groups: survey

For the second year in a row, the pharmaceutical industry has dipped further out of favor with patient groups around the world.

Pfizer, in sweeping cost cutting push, lifts overall savings target to $7.7B

The company added an extra $1.7 billion to its "cost realignment" drive, which was first announced in 2023.

Eli Lilly pens Creyon Bio AI oligonucleotide pact with $1B in biobucks on the table

Eli Lilly is paying $13 million upfront, with $1 billion in biobucks up for grabs, for the opportunity to develop AI-designed oligonucleotide therapies from Creyon Bio.

Sequel Med Tech to link Senseonics’ 365-day CGM with upcoming twiist insulin pump

Designed for people with Type 1 diabetes, the companies said the launch of the combined system is slated for the third quarter of this year.

Bayer gets industry discredit ruling overturned after accusation of ‘warming the market’ for Eylea launch

Bayer has overturned a ruling that it brought discredit on the pharma industry. Accused of “warming the market” for a new Eylea indication, the German drugmaker successfully argued on appeal that an advisory board was in fact legitimate.

Novo moves past GLP-1 spat with Hims & Hers, tapping telehealth company to offer discounted Wegovy

Novo Nordisk appears to be letting compounded GLP-1 bygones be bygones—at least, in one respect.

FDA misses PDUFA date for Stealth’s ultra-rare disease candidate, delaying approval decision—again

An approval decision for Stealth BioTherapeutics’ investigational treatment for an ultra-rare genetic disease has been delayed—again—this time, with no new decision date given.

Indivior-backed paper champions fast-acting overdose reversal meds against synthetic opioids

The company announced the paper’s publication on Tuesday, National Fentanyl Awareness Day, touting its Opvee as an opioid overdose reversal medication that aligns with the expert panel’s recommendations.

Novartis axes osteoarthritis asset and radioligand therapy after seeing clinical data

Novartis has done a little spring cleaning, sweeping a phase 2 osteoarthritis prospect and first-in-human radioconjugate out of its pipeline after assessing evidence on the programs.

AstraZeneca culls a Lilly-partnered Alzheimer's drug alongside 2 other neuroscience meds in Q1 clear-out

AstraZeneca has axed three MedImmune legacy monoclonal antibody drugs from its neuroscience pipeline in a first-quarter clear-out.

As Novartis builds momentum with new drug launches, CEO says he's 'comfortable' navigating US tariffs

Novartis has a lot cooking with new drug launches, and the company is not letting potential U.S. tariffs on pharmaceuticals get in the way of its progress.
 
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Resources

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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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