Astellas points to liver issues in gene therapy deaths

Today’s Big News

Nov 16, 2023

FDA skeptical of Merck’s gefapixant, even after cough recount  


A year after Roche's Alzheimer's failure, scientists reflect on what could have been


In analysis of gene therapy deaths, Astellas points to underlying liver issues


Astellas pays $175M for Propella, clearing early-phase rival to J&J's Zytiga for takeoff


AstraZeneca's Koselugo not a 'meaningful barrier' to SpringWorks' rare disease offering, executives say


Versant-backed 858 laid off select researchers, closed New York site tied to Gotham buy


'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says Sofinnova chair


Chemo drug makes Daiichi Sankyo ADC more effective against aggressive prostate cancer in mice

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

 

Featured

FDA skeptical of Merck’s gefapixant, even after cough recount

Merck & Co. is running out of time to get the first chronic cough medicine to market. So far, its path has been wrought with delays and the future appears no different as the FDA expresses new doubt about the pharma’s candidate gefapixant.
 

Top Stories

A year after Roche's Alzheimer's failure, scientists reflect on what could have been

Almost a year to the day after Roche revealed that its Alzheimer's drug gantenerumab failed a phase 3 trial, the data are appearing in The New England Journal of Medicine, giving scientists a chance to reflect on what was learned.

In analysis of gene therapy deaths, Astellas points to underlying liver issues

Astellas has shared a detailed look at the four deaths in its AT132 gene therapy clinical trial. Writing in The Lancet Neurology, the drugmaker explained that the liver toxicity seen in the trial differs from cases linked to other therapies—and made the case that the drug can provide transformative clinical benefits.

2023 Executive Interviews at Fierce Biotech Summit and New Product Planning

Fierce Biotech sits down with digital marketing leaders to discuss this year's most innovative topics at Fierce Biotech Summit and New Product Planning

Astellas pays $175M for Propella, clearing early-phase rival to J&J's Zytiga for takeoff

Astellas is spinning up a new attack on a cancer market, paying $175 million to buy Propella Therapeutics and its clinical-phase challenger to Johnson & Johnson’s fast-fading prostate cancer blockbuster Zytiga.

AstraZeneca's Koselugo not a 'meaningful barrier' to SpringWorks' rare disease offering, executives say

Patients with neurofibromatosis type 1 have an option for treatment: AstraZeneca’s Koselugo. But it’s “a difficult drug to take,” according to SpringWorks Therapeutics CMO Jim Cassidy, M.D. That’s where his biotech is hoping to make its move, and a batch of mid-stage data seems to support the case.

Versant-backed 858 laid off select researchers, closed New York site tied to Gotham buy

Changes have been afoot at 858 Therapeutics, an RNA biotech tackling cancer and CNS disorders. The company recently laid off an unspecified number of staffers in the research group to preserve funds and funnel money toward clinical development work in 2024.

'Optimism' at Jefferies conference, but don't expect biotech IPO boost soon, says Sofinnova chair

While the IPO markets are unlikely to unfreeze next year, according to Sofinnova's Antoine Papiernik, the "silver lining" is Big Pharma's appetite for M&A.

Chemo drug makes Daiichi Sankyo ADC more effective against aggressive prostate cancer in mice

New preclinical research on Daiichi Sankyo’s antibody-drug conjugate DS-7300a suggests it might be more effective against hard-to-treat forms of prostate cancer when used alongside a long-standing chemotherapy drug.

FDA hands down 2 more Class I labels to drug delivery device recalls, now from Baxter, Fresenius

In its second and third such notices this week, the FDA doled out its most serious label to recalls of syringe devices used in medication delivery.

Bristol Myers' $4.1B Turning Point buy yields FDA approval for lung cancer drug Augtyro

Watch out, Pfizer and Roche. Thanks to an acquisition and now an FDA approval, Bristol Myers Squibb is entering a niche lung cancer market.

Proposals on PBMs and medical devices advanced by House subcommittee

PBMs were a source of bipartisan agreement during a House hearing on Tuesday, while Republicans and Democrats clashed over durable medical equipment legislation.
 
Fierce podcasts

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'Podnosis': A deep dive into Q3 earnings, and key takeaways from the Fierce Health Payer Summit

In this week’s episode of "Podnosis," you'll hear from two journalists from the Fierce Healthcare team: Paige Minemyer, senior editor of Fierce Health Payer, and Dave Muoio, a staff writer for Fierce Healthcare. Together, they guide you through their key insights from the inaugural Fierce Health Payer Summit in Austin and dive into the latest earnings updates from the largest health plans and health systems.
 

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