Applied Therapeutics CEO departs

Today’s Big News

Dec 20, 2024

Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal


A 'pivotal moment': Ionis enters next phase of commercial evolution with Tryngolza's FDA approval


Applied Therapeutics CEO steps down in wake of FDA rejection, warning letter and investor lawsuit


Mirroring Merck's problem, GSK's Jemperli-Zejula study in ovarian cancer misses survival goal


ElectroCore to buy NeuroMetrix and its Quell fibromyalgia wearable stimulator


Sanofi and Regeneron's Dupixent, Leo Pharma's Anzupgo could help close treatment gap in chronic hand eczema: GlobalData


Sanofi scoops up China rights to Cytokinetics’ heart disease med ahead of approval decision


FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

 

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Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal

A phase 3 trial of Novo Nordisk’s next-generation obesity prospect CagriSema has failed to achieve the level of weight loss targeted by executives, prompting investors to wipe 19% off the value of the Danish drugmaker.
 

Top Stories

A 'pivotal moment': Ionis enters next phase of commercial evolution with Tryngolza's FDA approval

With an FDA approval for Tryngolza (olezarsen) to treat the rare genetic disorder familial chylomicronemia syndrome (FCS), Ionis Pharmaceuticals enters a new era. While Ionis has gained several FDA nods in its 35 years in existence, Tryngolza will be the first medicine the Carlsbad, California-based biotech will commercialize on its own.

Applied Therapeutics CEO steps down in wake of FDA rejection, warning letter and investor lawsuit

A turbulent month at Applied Therapeutics is being capped off with the departure of CEO and chair Shoshana Shendelman, Ph.D., mere days after she and the company were named in a proposed class action lawsuit.

Mirroring Merck's problem, GSK's Jemperli-Zejula study in ovarian cancer misses survival goal

Merck's and GSK's similar overall survival setbacks suggest that PD-1 inhibitors may not be for ovarian cancer after all.

ElectroCore to buy NeuroMetrix and its Quell fibromyalgia wearable stimulator

The deal, valued at about $9 million in cash to start, will see NeuroMetrix become an electroCore subsidiary—but, beforehand, the company plans to sell off its point-of-care screening test for peripheral neuropathy, DPNCheck, to add to the total proceeds.

Sanofi and Regeneron's Dupixent, Leo Pharma's Anzupgo could help close treatment gap in chronic hand eczema: GlobalData

The lack of any approved treatments that are helpful in managing both underlying inflammation and external symptoms without tacking on any major side effects has created a significant gap in the chronic hand eczema space that may be filled by up-and-coming treatments, according to a new report from GlobalData.

Sanofi scoops up China rights to Cytokinetics’ heart disease med ahead of approval decision

As Cytokinetics’ aficamten awaits approval decisions from regulators in the U.S. and China, Sanofi has picked up China rights to the cardiovascular candidate.

FDA reaffirms decision to erase Eli Lilly's tirzepatide from shortage list, halting future flow of knockoffs

The FDA has doubled down on its decision to remove Eli Lilly’s tirzepatide from its list of products that are in shortage. The agency’s move means that compounding pharmacies will have to halt production of their knockoff versions of diabetes drug Mounjaro and obesity treatment Zepbound.

Clinical research company Javara lays off employees as part of restructuring

Clinical research firm Javara has laid off staff as part of a restructuring, a spokesperson confirmed to Fierce Biotech in an email.

Omnicom Health Group CEO McNally to step down amid Interpublic merger plans

On the heels of Omnicom’s announcement earlier this month that it’s acquiring fellow marketing giant Interpublic Group, the head of Omnicom’s health-focused agency is stepping down.

Chutes & Ladders—FDA's principal deputy to depart agency

After less than a year on the job, the FDA’s principal deputy commissioner, Namandjé Bumpus, Ph.D., is leaving her post at the end of the year, according to an internal agency email reviewed by Fierce Biotech.

Fierce Pharma Asia—Merck's oral GLP-1 play; Astellas' gene therapy deal; Betta's FDA nod

Merck in-licensed a preclinical oral GLP-1 candidate from China's Hansoh Pharma. Astellas doubled down in gene therapy with a viral capsid deal with Sangamo Therapeutics. Betta Pharma's Ensacove became the first innovative targeted lung cancer med developed by a Chinese company to win FDA approval. And more.

Fierce 50 honorees look ahead: AI, rural health, antibiotic resistance, maternal care and more

This week on "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees.
 
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Fierce 50 honorees look ahead: AI, rural health, antibiotic resistance, maternal care and more

This week on "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees.
 

Resources

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Building a “Best Practice” R&D Organization in Biopharma

We interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned.
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Single Cell RNA Profiling FFPE Tissue

Explore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence.
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Straight to Market in an Autoinjector

The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.
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Planning for success in cell-based manufacturing

Learn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes.
 

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