Biogen CMO exits alongside neuromuscular exec

Today’s Big News

Mar 15, 2024

Moderna won’t advance US-backed Zika vaccine without more outside funding


Madrigal landed a historic MASH approval. What comes next for biotechs in pursuit?


Biogen's CMO Maha Radhakrishnan departs, leaving behind a legacy in Alzheimer's drug development


Geron triumphs in FDA AdComm battle, securing 12-2 vote in favor of blood cancer drug imetelstat


Hansoh, fresh from Big Pharma deal table, signs $690M ADC pact with Biotheus


Chutes & Ladders—Voyager plucks another Biogen exec for top post


'The Top Line': Inclusivity in psoriasis trials with Takeda

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

 

Featured

Moderna won’t advance US-backed Zika vaccine without more outside funding

Moderna does not plan to advance a midstage Zika vaccine without additional outside cash, despite receiving US funding thus far, according to a regulatory disclosure. 
 

Top Stories

Madrigal landed a historic MASH approval. What comes next for biotechs in pursuit?

Madrigal Pharmaceuticals’ metabolic dysfunction-associated steatohepatitis drug has been approved, to be sold as Rezdiffra. For the other companies with up-and-coming treatments in the clinic, the question is: What now?

Biogen's CMO Maha Radhakrishnan departs, leaving behind a legacy in Alzheimer's drug development

Biogen CMO Maha Radhakrishnan has departed the company, a spokesperson confirmed. It was her second stint at the company after she rejoined in 2020.

Geron triumphs in FDA AdComm battle, securing 12-2 vote in favor of blood cancer drug imetelstat

Geron has triumphed in its latest uphill battle. Facing questions about the trade-offs of its blood cancer drug candidate imetelstat, the biotech won over an FDA advisory committee and secured a 12 to 2 vote in its favor—triggering a surge in its share price.

Hansoh, fresh from Big Pharma deal table, signs $690M ADC pact with Biotheus

During Big Pharma’s flurry of antibody-drug conjugate (ADC) deals late last year, China emerged as the go-to location to source the tech for this red-hot modality. Now, two Chinese biotechs have paired up again for their own ADC exercise.

Chutes & Ladders—Voyager plucks another Biogen exec for top post

Voyager Therapeutics plucks another Biogen exec, naming Ferguson as new CMO. Pfizer names CSO for anti-infectives research unit. Rigel hires CMO vet for same role.

'The Top Line': Inclusivity in psoriasis trials with Takeda

In this episode of 'The Top Line,' Fierce Biotech Senior Editor Annalee Armstrong interviews Karen Correa, Ph.D., from Takeda, discussing the crucial need for pharmaceutical companies to prioritize diversity in clinical trials.

FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard

The decades-long wait for an effective treatment for metabolic dysfunction-associated steatohepatitis (MASH) has ended. The FDA has approved Madrigal's resmetirom under the brand name Rezdiffra as the first drug for the fatty liver disease.

Digital diabetes app maker Better Therapeutics shutters operations, lays off staff

Better Therapeutics had previously laid off a third of its workers and instituted company-wide pay cuts as it sought reimbursements and revenue for its AspyreRx cognitive behavioral therapy app for Type 2 diabetes.

GLP-1s on track to take drug sales throne from PD-1 inhibitors in 2024: analyst

As GLP-1 drugs like Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic and Wegovy have spent the last couple of years skyrocketing in popularity—with no signs of slowing down—it was perhaps only a matter of time before they further shook up the pharma industry.

Exact, Guardant tout successes of next-gen colorectal cancer screeners

The latest issue of the New England Journal of Medicine featured a duet of expansive studies from Guardant Health and Exact Sciences, examining their upcoming tests that aim to increase screening rates and catch earlier cases of colorectal cancer.

Fierce Pharma Asia—BIO-WuXi break-off; Takeda's site closure; FDA's concern over Carvykti

WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S. lawmakers target certain Chinese biotechs. Takeda will shut down a gene therapy manufacturing and R&D facility in Austria. The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. And more.

Health spending spikes in Massachusetts amid high drug expenses, unprecedented patient cost sharing, regulator warns

The Bay State's healthcare cost growth benchmark program is calling for policy action after a report showed per-person health spending well above the national average.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Inclusivity in psoriasis trials with Takeda

In this episode of 'The Top Line,' Fierce Biotech Senior Editor Annalee Armstrong interviews Karen Correa, Ph.D., from Takeda, discussing the crucial need for pharmaceutical companies to prioritize diversity in clinical trials.
 

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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