Inventiva adjusts MASH trial after adverse event

Editor's Note: Fierce Biotech will be taking a break for the Presidents Day holiday. Enjoy your long weekend, and we'll be back in your inboxes on Tuesday, February 20.

Today’s Big News

Feb 16, 2024

Gilead pauses CD47 solid tumor trials as FDA seeks partial hold, adding to woes after blood cancer exit


Astellas-owned Xyphos offers more than $800M for Kelonia's in vivo delivery know-how


Inventiva pauses phase 3 MASH study over patient's raised liver enzymes


Karuna shareholder sues biotech, CEO Bill Meury over $14B BMS merger


Synthetic antibiotic boosts survival in mice with multidrug-resistant infections


Sana's engineered pancreatic islet cells control blood sugar in monkey model of Type 1 diabetes


'The Top Line': Gene editing's next act


Chutes & Ladders—Exscientia CEO out after 'inappropriate' relationships with 2 staffers

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Gilead pauses CD47 solid tumor trials as FDA seeks partial hold, adding to woes after blood cancer exit

The dominoes keep falling at Gilead. One week after reporting deaths in blood cancer patients, the Big Biotech has paused enrollment of magrolimab solid tumor trials after the FDA requested a partial clinical hold on the anti-CD47 monoclonal antibody.
 

Top Stories

Astellas-owned Xyphos offers more than $800M for Kelonia's in vivo delivery know-how

Astellas is betting up to $800 million on Kelonia's in vivo genetic delivery tech through its cell therapy subsidiary Xyphos. Kelonia will earn $40 million in an upfront payment for the first candidate from the deal.

Inventiva pauses phase 3 MASH study over patient's raised liver enzymes

Inventiva has paused enrolling new patients into a phase 3 trial of its lead liver disease drug after one participant experienced raised enzyme levels.

2024 Executive Interviews at Fierce JPM Week

Fierce Life Sciences and Healthcare sit down with biotech, pharma, and healthcare executives at Fierce JPM Week.

Karuna shareholder sues biotech, CEO Bill Meury over $14B BMS merger

A Karuna Therapeutics stockholder is suing the biotech, claiming that the company and its directors didn’t include or misrepresented key information in a proxy statement urging shareholders to vote in favor of the proposed Bristol Myers Squibb merger.

Synthetic antibiotic boosts survival in mice with multidrug-resistant infections

A new synthetic antibiotic appears to be effective against deadly drug-resistant pathogens, a development in the scramble to find solutions for the growing problem of antimicrobial resistance.

Sana's engineered pancreatic islet cells control blood sugar in monkey model of Type 1 diabetes

The transplanted islet cells controlled the animal's glucose levels for six months without requiring insulin or immunosuppression, a step toward treating Type 1 diabetes without injectable insulin.

'The Top Line': Gene editing's next act

This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.

Chutes & Ladders—Exscientia CEO out after 'inappropriate' relationships with 2 staffers

Exscientia fired founder and CEO Andrew Hopkins after an internal investigation found that he had “inappropriate” relationships with two other employees. Chief Scientific Officer Dave Hallett has been tapped as interim CEO while a full search gets underway. 

Sosei ushers in new era with Nxera Pharma name change

The Sosei Group is making a major change to its corporate business as it renames and changes up its head office location.

After migraine accord with Eli Lilly, Organon CEO scouts more deals to bolster growth

After picking up European rights to a pair of Eli Lilly migraine meds in December, Organon is hungry to ink more deals.

Fierce Pharma Asia—Takeda's surprise Eohilia nod; WuXi's darkest moment; LianBio's dissolution

Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. LianBio, a prominent player in bringing foreign meds to China, will wind down. Plus more.

Nema Health, a virtual clinic for PTSD, announces Horizon BCBSNJ as partner

Nema is now in-network for commercial members with Horizon Blue Cross Blue Shield of New Jersey. Through this and another contract with a major national payer, Nema will reach about 3.6 million lives in the state.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Gene editing's next act

This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.
 

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

This paper offers a detailed review of key events and developments in the oncology market during 2023.  It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more.

Whitepaper

Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

 

Industry Events

 

Upcoming Fierce Events

11-12
Mar
San Francisco, CA
18-20
Mar
Savannah, GA
6-8
May
Jersey City, NJ
13-15
May
Newport Beach, CA
14-15
May
Newport Beach, CA

View all events