What’s next for MASH after historic approval?

Today’s Big News

Mar 15, 2024

Despite early death concerns, FDA advisers back J&J and Legend's Carvykti for earlier myeloma


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? 


With Pfizer struggling in 2023, CEO Bourla sustains 35% pay cut to $21.6M 


Intuitive Surgical launches latest da Vinci robot, with force feedback controls 


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

 

Featured

Despite early death concerns, FDA advisers back J&J and Legend's Carvykti for earlier myeloma

Even though the BCMA CAR-T therapy Carvykti showed a potential problem of early patient deaths in a trial, experts on the FDA’s Oncologic Drugs Advisory Committee still believe that the drug’s long-term benefits outweigh its risks.
 

Top Stories

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. 

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?

With Pfizer struggling in 2023, CEO Bourla hit with 35% pay cut to $21.6M

After a difficult year for Pfizer, in which its share price fell by 44%, CEO Albert Bourla’s compensation fell by 35% from $33 million in 2022 to $21.6 million in 2023.

Intuitive Surgical launches latest da Vinci robot, with force feedback controls

Intuitive Surgical has received an FDA green light for the fifth generation of its multiport da Vinci robot, following more than a decade of research and development.

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.

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.

Merck's Keytruda excels in cervical cancer trial, showing an ability to extend lives. Will a broader FDA approval follow?

Two months after Keytruda became the first PD-1 drug to be approved in the U.S. in combination with chemoradiotherapy (CRT) to treat patients with stage 3 to 4a cervical cancer, Merck’s superstar immunotherapy has strengthened its resume in the indication. A pre-specified interim analysis from the KEYNOTE-A18 trial shows that the combo regimen significantly improved overall survival versus CRT alone in patients with earlier-stage cervical cancer, the company reported on Friday.

Merck’s Keytruda claims digital marketing crown, holding off challenges from AstraZeneca, BMS

Merck’s dominance of the PD-1/L1 checkpoint inhibitor space extends to the digital realm. That is the topline finding of a study of digital marketing trends, which found Merck has the highest traffic to patient and unbranded U.S. sites about non-small cell lung cancer (NSCLC).

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.

Oxford Nanopore taps SeqOne for rare disease DNA diagnostic partnership

The goal will be to provide an end-to-end platform that applies extra-long nanopore sequencing reads to whole genomes—initially in order to help identify variants associated with rare diseases, before expanding the project’s scope into cancer testing.

Bristol Myers nabs new FDA nod as Breyanzi brings CAR-T class to chronic lymphocytic leukemia

Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.
 
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'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.
 

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