Merck KGaA’s MS drug passes mid-phase durability test

Today’s Big News

Oct 11, 2023

Akero's NASH miss drags a few peers down, spurring deja vu in long-challenging indication


As Federation folds, Kanvas Bio picks up the pieces to become clinical-stage company


Merck KGaA, with hold still clouding prospects, guides MS drug past durability test ahead of phase 3 data 


Tempest’s triplet treatment had an advantage over Roche combo in liver cancer 


Agomab adds $100M in series C funds to push ALK5 inhibitor through phase 2 Crohn's trial


Sana edits plans again, retreating from in vivo CAR-T delivery and laying off 29% of staff to cut costs 


'Unprecedented': CRISPR-edited pig kidney lasts for two years in primates


Fierce Biotech Fundraising Tracker '23: Agomab corrals $100M series C; AstronauTx raises $61M

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

 

Featured

Akero's NASH miss drags a few peers down, spurring deja vu in long-challenging indication

Things were going pretty well in the NASH landscape with Madrigal Therapeutics finally submitting a request to approve a treatment, but yesterday the space came crashing back down to reality with the failure of Akero Therapeutics’ med.
 

Top Stories

As Federation folds, Kanvas Bio picks up the pieces to become clinical-stage company

As Federation Bio fades, Kanvas Biosciences has snapped up two of the biotech’s assets as well as its microbial library and the company’s chief scientific officer Lee Swem, Ph.D., to lead program development.

Merck KGaA, with hold still clouding prospects, guides MS drug past durability test ahead of phase 3 data

Merck KGaA is back with another update on the durability of its BTK inhibitor evobrutinib, sharing data that show the effect on relapse rates lasts for at least five years. But with the program on partial clinical hold and phase 3 data imminent, the update may soon be overshadowed by other developments.

Changing the Pharmaceutical Commercialization Landscape

In a dynamic landscape, three emerging trends have the power to reshape the complexities of pharmaceutical commercialization.

Tempest’s triplet treatment had an advantage over Roche combo in liver cancer

Tempest's triplet treatment has shown an advantage over the combo of two Roche drugs for patients with liver cancer in a phase 1/2 trial. The data validate earlier, more preliminary figures reported in April.

Modeling patient insights to make the most of clinical trials

Greg Lever, Director within the IQVIA Applied Data Science Center, reveals how modeling technology is being used to unlock value and enhance the experience of trial participants.

Agomab adds $100M in series C funds to push ALK5 inhibitor through phase 2 Crohn's trial

A week after entering its lead asset into a phase 2 trial for a type of Crohn’s disease, Agomab Therapeutics has secured $100 million in series C financing to power up its pipeline.

AnaptysBio announces top-line data showing rapid clearance of generalized pustular psoriasis (GPP), a rare systemic skin disease

AnaptysBio announces top-line data showing rapid clearance of generalized pustular psoriasis (GPP), a rare systemic skin disease

Sana edits plans again, retreating from in vivo CAR-T delivery and laying off 29% of staff to cut costs

Sana Biotechnology is restructuring and narrowing its focus for the second time in 11 months. With its stock in the doldrums, the cell engineering biotech is pulling back from its in vivo delivery platform and reducing its head count by 29% to stretch its cash runway deeper into 2025.

'Unprecedented': CRISPR-edited pig kidney lasts for two years in primates

Scientists for the first time have accomplished long-term kidney transplant from pigs to primates using a clinically-translatable immunosuppression protocol, a potential turning point in their quest to use animal donors to combat a longstanding shortage of transplant organs.

Fierce Biotech Fundraising Tracker '23: Agomab corrals $100M series C; AstronauTx raises $61M

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

FDA sends warning letters to sellers of unapproved versions of Novo's Wegovy and Lilly's Mounjaro for obesity

Such is the demand for new anti-obesity drugs that several online companies have begun trying to sell the latest “must-have” meds—but without approval or prescription, and that has irked the FDA.

EU order for Illumina to divest Grail could arrive within the week: reports

Regulators in the EU are said to be on the verge of handing down an order forcing Illumina to divest Grail, according to multiple reports this week, following a yearslong antitrust battle that’s stretched across the Atlantic.

Humana CEO Bruce Broussard to step down next year

Humana CEO Bruce Broussard will step down from the role in the latter part of 2024, and the insurer has already found a successor.

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

In a phase 3 trial testing the two forms over 24 weeks, the subcutaneous drug measured up to the IV version, Roche said. An approval for the subcutaneous version would open the door to broader usage.
 
Fierce podcasts

Don’t miss an episode

'Podnosis': Gaming for better healthcare

In this week's episode of "Podnosis," we explore how video game training can captivate users' minds while also expediting the adoption of new skills and treatments in medicine.
 

Resources

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Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

 

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