FDA expands Lykos probe: WSJ

 

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Today’s Big News

Aug 26, 2024

Preclinical gene editor Tome is laying off 131 staffers, virtually its entire workforce


MBX files for IPO, seeking cash to take challenger to Ascendis' Yorvipath into phase 3


Lykos' woes mount as FDA expands probe into its MDMA-based research: WSJ


Galapagos investor signals intent to influence company's control, argues the biotech is 'deeply undervalued' 


After phase 2 fail, Actinogen reports new data in bid to salvage depression drug xanamem 


Understanding how pythons swallow massive meals may help develop new human heart medicines 


Fierce Biotech Layoff Tracker 2024: Bayer cuts hit Basel; Tome lays off 131 staffers

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

 

Featured

Preclinical gene editor Tome is laying off 131 staffers, virtually its entire workforce

Just days after gene editor Tome Biosciences announced undisclosed operational cuts, a clearer picture is coming into focus as 131 employees are being laid off.
 

Top Stories

MBX files for IPO, seeking cash to take challenger to Ascendis' Yorvipath into phase 3

MBX Biosciences has added to the recent flurry of IPO filings. The biotech, which filed its paperwork weeks after raising $63.5 million privately, is seeking funding to take a would-be challenger to Ascendis Pharma’s rare endocrine disease drug Yorvipath into phase 3 development.

Lykos' woes mount as FDA expands probe into its MDMA-based research: WSJ

For Lykos Therapeutics and the company’s would-be MDMA-assisted therapy for post-traumatic stress disorder (PTSD), the hits just keep coming. Earlier this month, Lykos was hit by an FDA rejection, research paper retractions and layoffs. Now, the FDA is looking into studies sponsored by the company, The Wall Street Journal reports.

The Evolving Alzheimer’s Disease Landscape

New disease-modifying drugs, biological pathways and blood-based biomarker tests are among the rapid changes shaping the Alzheimer’s disease landscape

Galapagos investor signals intent to influence company's control, argues the biotech is 'deeply undervalued'

Galapagos is coming under additional pressure from investors. Having built a 9.9% stake in Galapagos, EcoR1 Capital is now planning to talk to the Belgian biotech about its performance and the composition of its board.

The Crucial Role of HEK293 DNA Quantification in Biotherapeutics

In this episode of The Top Line, sponsored by Bio-Rad, Dipika Gurnani delves into the challenges and solutions of quantifying HEK293 DNA in biotherapeutics, a field revolutionizing healthcare for over 350 million patients worldwide.

After phase 2 fail, Actinogen reports new data in bid to salvage depression drug xanamem

Actinogen Medical’s hopes—and stock price—have rebounded slightly from earlier this month, when the Australian biotech announced its cortisol blocker had failed to improve attention and memory in patients with cognitive dysfunction and major depressive disorder.

Understanding how pythons swallow massive meals may help develop new human heart medicines

To digest large, infrequent feasts, a python's heart works overtime by increasing oxygen use, pumping more blood and swelling in size. This rapid response requires a heart that is soft and flexible, the opposite of the stiff and fibrous heart that is characteristic of many human cardiac diseases.

Fierce Biotech Layoff Tracker 2024: Bayer cuts hit Basel; Tome lays off 131 staffers

We really didn't want to have to create another Layoff Tracker this year. But here we are, launching the third annual iteration tracking biopharma layoffs. 

Dexcom's Stelo, its first over-the-counter glucose monitor, hits the market

After getting the green light from the FDA back in March, Dexcom today launched its first over-the-counter wearable continuous glucose biosensor, Stelo, in the U.S. market.

With new focus, Kyowa Kirin pulls decades-old breast cancer drug Fareston from US market

Breast cancer treatments have evolved dramatically over the years, so Kyowa Kirin has decided to stop selling a decades-old drug in the U.S.
 
Fierce podcasts

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What Chevron’s overturn means for biopharma

This week on "The Top Line," we look at the potential effects of the Chevron overturn on the biopharma industry.
 

Resources

Whitepaper

Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.
Whitepaper

Launching a Product in Europe: Understanding Supply Chain Cost Drivers

This paper explores the costs of setting up a supply chain in Europe for a new biopharma therapy. It outlines key cost drivers & the various levers decision makers can use to affect those costs.
 

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