FDA refreshes Alzheimer’s disease guidelines

Today’s Big News

Mar 12, 2024

Merck bets up to $1B on Pearl's 'smart' biomaterial jewels as biotech begins to raise fresh funds


To boldly go back: Lilly charts second space trip in 4 months, this time with chronic disease tests


FDA guidelines consider amyloid reduction 'reasonably likely' to predict Alzheimer's benefit


BMS checks out of next-gen Yervoy pact with CytomX, taking $300M in biobucks with it


Mustang Bio, City of Hope CAR-T therapy extends survival in phase 1 glioblastoma trial

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Featured

Merck bets up to $1B on Pearl's 'smart' biomaterial jewels as biotech begins to raise fresh funds

Merck is signing onto a new research and licensing deal with Pearl Bio, offering up to $1 billion in biobucks. The biotech is looking at fusing synthetic chemistry with biologics, broadening its therapeutic capabilities.
 

Top Stories

To boldly go back: Lilly charts 2nd space trip in 4 months, this time with chronic disease tests

Eli Lilly is launching back into space for another round of experiments, after taking its first flight in late 2023. The focus of the new voyage is experimenting with chronic disease drug discovery.

FDA guidelines consider amyloid reduction 'reasonably likely' to predict Alzheimer's benefit

The FDA isn’t going as far to say that amyloid reduction can be considered a primary endpoint in Alzheimer’s disease trials, but the agency is suggesting that the measure can serve as a surrogate endpoint for predicting clinical benefit.

BMS checks out of next-gen Yervoy pact with CytomX, taking $300M in biobucks with it

Bristol Myers Squibb has checked out of its CytomX Therapeutics checkpoint inhibitor pact, walking away from a potential successor to Yervoy and wiping $300 million off the value of the alliance in the process.

Mustang Bio, City of Hope CAR-T therapy extends survival in phase 1 glioblastoma trial

Mustang Bio and City of Hope’s chimeric antigen receptor T cell therapy for recurrent glioblastoma resulted in stable disease or better in half of the subjects in a phase 1 clinical trial, including one patient who has survived without recurrence for more than five years.

Legend CEO offers preview of high-stakes FDA adcomm for J&J-partnered Carvykti

J&J and Legend have submitted two more overall survival updates for Caryvkti since the original data release last year, Legend's CEO said on an analyst call. The FDA is expected to release more data on the CAR-T therapy later this week, ahead of an advisory committee meeting set for Friday.

Eli Lilly flags bacteria, impurity concerns in fake and compounded versions of popular GLP-1 meds

The company republished an open letter reiterating its commitment to taking legal action against scam sellers after discovering bacteria and impurities in some of the fraudulent meds.

Breaking down Biden's $7.3T proposed budget for 2025: Here are his top health priorities

Drug price negotiations and Medicare solvency were just two areas HHS officials hit upon while unveiling President Biden's 2025 fiscal year proposed budget.
 
Fierce podcasts

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'The Top Line': Fierce Medtech's Fierce 15

In this week's episode of "The Top Line," join Conor Hale, Senior Editor of Fierce Medtech, and Andrea Park, Deputy Editor of Fierce Life Sciences, as they share the highlights of this year's Fierce Medtech Fierce 15. 
 

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.

 

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