Roivant's longshot lupus program misses

Today’s Big News

Nov 27, 2023

2023's Fiercest Women in Life Sciences 


CRISPR Therapeutics laid off employees on heels of positive FDA AdComm: sources


Roivant ends longshot lupus program after phase 2 fail


GSK jilts Sosei, dropping bowel disease asset on cusp of clinic amid changes at immunology unit


AstraZeneca pays $24M to join race for next big KRAS opportunity, bagging Chinese rival to Mirati asset


New chapter in Theseus’ adventure as troubled biotech approached by two potential suitors 


Xenon's major depressive med fails phase 2, but company keeps faith in seizure potential


'The power of open innovation for drug discovery': COVID-19 Moonshot pioneers share their story 

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

 

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2023's Fiercest Women in Life Sciences

In many ways, 2023 has been a banner year for women, thanks to Barbie, Beyoncé, Taylor Swift and so many other female powerhouses the world over.
 

Top Stories

CRISPR Therapeutics laid off employees on heels of positive FDA AdComm: sources

CRISPR Therapeutics laid off some of its staffers a week after FDA advisers endorsed the company's Vertex-sponsored, gene-edited cell therapy, according to the three sources. The company reported having more than $1.7 billion in cash as of the end of September.

Roivant ends longshot lupus program after phase 2 fail

Roivant’s CEO Matt Gline always knew the lupus drug brepocitinib was a longshot: “Anybody who is not afraid of a lupus study is an idiot, you shouldn’t trust them,” he told Fierce Biotech at the beginning of the year. Now, it seems Gline’s fear was warranted.

Ethical, Regulatory, and Operational Considerations for Cell and Gene Therapy Research in Children

Pediatric CGT trials have the potential to cure diseases and prolong lives. Discover steps to protect safety and enhance operations in your CGT trials.

GSK jilts Sosei, dropping bowel disease asset on cusp of clinic amid changes at immunology unit

GSK has jilted Sosei Heptares on the cusp of the clinic. With approval to start first-in-human studies in place, the Big Pharma has backed out of the program, reportedly because of changes at its immunology unit, and returned full rights to an inflammatory bowel disease asset Sosei sees as a potential blockbuster.

AstraZeneca pays $24M to join race for next big KRAS opportunity, bagging Chinese rival to Mirati asset

AstraZeneca’s business development team has landed another asset in its new favorite hunting grounds. Partnering with a Chinese biotech once again, the Anglo-Swedish drugmaker has secured a spot in the congested KRAS G12D space in exchange for $24 million upfront.

New chapter in Theseus’ adventure as troubled biotech approached by two potential suitors

It’s been a wild November for Theseus Pharmaceuticals. Just a couple of weeks ago, the biotech laid off almost three-quarters of its staff. Days later, the company received offers from two sets of potential buyers.

Xenon's major depressive med fails phase 2, but company keeps faith in seizure potential

Xenon hopes to expand its lead asset's use beyond epilepsy, but phase 2 data in patients with major depressive disorder has missed the mark.

'The power of open innovation for drug discovery': COVID-19 Moonshot pioneers share their story

On the heels of a major publication from the COVID-19 Moonshot project, an open science initiative involving hundreds of scientists from around the world who sought to develop new COVID antivirals, Fierce spoke with leaders Alpha Lee and Annette von Delft to chat about the program's challenges, successes and learnings that can be applied to drug discovery more broadly.

Novo Nordisk keeps GLP-1 expansion spree rolling with $2.3B manufacturing upgrade in France

After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. Now, some three weeks later, he’s putting his company’s money where his mouth is.

Roche grows hepatitis diagnostics roster with new immunoassays

For the second time this month, Roche is launching a new immunoassay to help diagnose cases of hepatitis.

Pfizer's cost-savings mission continues with office shuffle, job cuts in Ireland

Pfizer's commercial office in Citywest, Dublin, will move to its Ringsend office building, the Irish Independent reports. The moves could end in more job cuts in the company's commercial division.

Hospitals: UHC's 2024 MA coverage policy 'blatantly violates' new CMS coverage requirements

The nation's largest MA operator is skirting new CMS regulations prohibiting MA plans from limiting or denying coverage for hospital services that would be covered under traditional Medicare, the hospital industry told federal officials this week.

NS Pharma launches ‘Duchenne Heroes’ campaign to help families navigate the Duchenne journey

NS Pharma is launching a new educational campaign for Duchenne Muscular Dystrophy (DMD) aimed at assisting families with DMD patients in navigating both the emotional and medical aspects of their journey.
 
Fierce podcasts

Don’t miss an episode

Alzheimer’s breakthroughs, Leqembi's potential and what's next

This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge.

 

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Artificial Intelligence in Healthcare & Medical Affairs

This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.
 

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