Ironwood spies new use for $1B GLP-2 analog

Editor's Note: Voting is now open in #FierceMadness: The Best Biotech Name Tournament for the Sweet 16 round. Get your votes in!

Today’s Big News

Mar 28, 2024

Gilead pays $43.5M for early-phase IL-12 prospect from Xilio as biotech reduces head count


Moderna's early vaccine pipeline underpinned by Epstein–Barr, norovirus and shingles prospects


Ironwood spies new frontier for $1B GLP-2 analog in exploratory phase 2 rare disease trial


Milestone resubmits new drug application while Aldeyra readies similar 2nd-chance filing


Boundless Bio boldly goes public with $100M IPO


Avalo signals change in fortunes by snapping up AlmataBio for ex-Lilly inflammatory drug


GAO report: FDA should inspect hiring practices as it struggles to find and keep investigators 

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

 

Featured

Gilead pays $43.5M for early-phase IL-12 prospect from Xilio as biotech reduces head count

Gilead is bucking the trend in IL-12, handing Xilio Therapeutics $43.5 million upfront to get into the space after seeing rivals such as AstraZeneca and Bristol Myers Squibb retreat from the cytokine. Xilio shared the news alongside details of plans to pull back from another program and lay off 21% of its staff.
 

Top Stories

Moderna's early vaccine pipeline underpinned by Epstein–Barr, norovirus and shingles prospects

Moderna gave its clearest look yet at a third wave of vaccine products during the company's annual vaccines business review on Wednesday. Early-stage shots aimed at Epstein–Barr virus, norovirus and shingles could further solidify the biotech's infectious disease portfolio.

Ironwood spies new frontier for $1B GLP-2 analog in exploratory phase 2 rare disease trial

Ironwood Pharmaceuticals’ stargazing has identified a new frontier for apraglutide by generating early clinical evidence that the GLP-2 analog plays nicely with Incyte’s Jakafi in a rare disease. The company acquired the molecule last year through its $1 billion takeover of VectaBio.

Milestone resubmits new drug application while Aldeyra readies similar 2nd-chance filing

Milestone Pharmaceuticals has resubmitted a new drug application to the FDA, with Aldeyra readying a similar ask for the second half of the year.

Boundless Bio boldly goes public with $100M IPO

Boundless Bio is bringing in $100 million from its IPO as the precision oncology company becomes the latest biotech to go public in 2024.

Avalo signals change in fortunes by snapping up AlmataBio for ex-Lilly inflammatory drug

Avalo Therapeutics is handing over more than $22 million in stock and cash to acquire AlmataBio for a phase 2-ready monoclonal antibody for hidradenitis suppurativa.

GAO report: FDA should inspect hiring practices as it struggles to find and keep investigators

The FDA should audit the hiring practices of its Bioresearch Monitoring program to see whether its efforts to attract more investigators and improve drug trial oversight are paying off, particularly as retention has largely failed to improve, the GAO said in a new report.

FDA to ban electric shock devices for behavior control—again

The agency previously took the rare step of banning the use these devices in March 2020, but the FDA's ban was overturned on appeal in July 2021.

High prices on GLP-1 meds, insulin pens raise barriers to access in lower-income countries: MSF

Médecins Sans Frontières urged GLP-1 drug makers to "relinquish their stranglehold" on the products and license the meds to generics makers to boost access.

GAO: Improper payments in federal programs neared $236B last year

A new report finds that the federal government made nearly $236 billion in improper payments across entitlement programs last year, with Medicare and Medicaid a large source of payment errors.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': A closer look at European biotech investment in 2024

This week on “The Top Line,” we explore the European biotech investment landscape. Fierce Biotech’s James Waldron sits down with Maina Bhaman, a Partner at Sofinnova Capital Strategy, who provides insights into how investors are approaching the European biotech sector. 
 

Resources

Whitepaper

Pediatric Clinical Trials: Considerations for Enrollment and Retention

Explore the nuanced approaches necessary for successful pediatric drug development.
Whitepaper

CNS Market Outlook, 2024

This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment.

 

Industry Events

Drug Development Boot Camp® VIRTUAL | Spring 2024

April ‌10-11, ‌2024

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

Upcoming Fierce Events