Plus our top stories of the week

This Week

Oct 11, 2024

Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list 


J&J stops phase 3 trial of $5B bladder cancer prospect after interim review flop


Pfizer CEO Bourla to meet with activist investor Starboard Value on turnaround pitch: FT


Baxter offers recovery timeline after major IV fluid plant closure due to Hurricane Helene


This year's biopharma layoff rate on track with 2023: Fierce Biotech Q3 analysis


For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been 


FDA approves Exact Sciences’ next-gen Cologuard Plus home screening test

 

Featured

Compounders sue FDA for removing Eli Lilly's tirzepatide from shortage list

A compounding industry group has sued the FDA, claiming its action to remove Eli Lilly’s Mounjaro and Zepbound from its drug shortage list is a “reckless and arbitrary decision—lacking any semblance of lawful process.” In declaring the end of the shortage, the FDA has halted the ability of compounding pharmacies to manufacture the in-demand products.
 

Top Stories

J&J stops phase 3 trial of $5B bladder cancer prospect after interim review flop

The sun has set on Johnson & Johnson’s SunRISe-2 study. J&J called a halt to the phase 3 bladder cancer trial after an interim look at the data showed the TAR-200 candidate was no better than chemoradiation.

Pfizer CEO Bourla to meet with activist investor Starboard Value on turnaround pitch: FT

Activist investor Starboard Value recently picked up a $1 billion stake in the drugmaker and will now pitch a strategy shift to top executives, the Financial Times reported.

Baxter offers recovery timeline after major IV fluid plant closure due to Hurricane Helene

Following the recent closure of its manufacturing facility in Marion, North Carolina, from flooding caused by Hurricane Helene, Baxter is providing some clarity on remediation timelines.

This year's biopharma layoff rate on track with 2023: Fierce Biotech Q3 analysis

As summer heat turns to cool winds, hopes that this year would bring widespread industry relief have dissipated, with quarterly layoffs evening out to similar levels as the same time last year.

For Bristol Myers Squibb's newly approved schizophrenia drug, what a long, strange trip it's been

Off the scrapheap of discarded drugs and on its way to becoming the most highly anticipated approval of 2024, Bristol Myers Squibb’s schizophrenia treatment Cobenfy (KarXT) has had an unusual odyssey and one that may serve as instructive for future drug discovery.

FDA approves Exact Sciences’ next-gen Cologuard Plus home screening test

Cologuard Plus represents the next generation of the company's mainstay, at-home screening test for colorectal cancer.

Nobel Prize in Physiology or Medicine awarded to 2 discoverers of microRNA

The Nobel Assembly at the Karolinska Institute has taken a liking to RNA. The committee has awarded two American biologists the 2024 Nobel Prize in Physiology or Medicine for their discovery of microRNA, the small RNA molecules that regulate genes, one year after the prize went to scientists who conducted foundational work on mRNA vaccines.

Nobel Prize in Chemistry awarded to 3 scientists for predicting and designing proteins

A day after the Physics prize was given to two scientists for foundational work on machine learning, the Nobel Prize in Chemistry has been awarded to three scientists who used advanced computational methods to solve a decades-old problem.

BeiGene launches PD-1 drug Tevimbra at 10% discount to Merck's Keytruda

BeiGene is pricing Tevimbra at a 10% discount to other PD-1 therapies available in second-line esophageal squamous cell carcinoma.
 
Fierce podcasts

Don’t miss an episode

How do we prevent chronic kidney disease upstream?

This week on "Podnosis," Fierce Healthcare's Emma Beavins chats with Healthy.io CEO Geoff Martin about how his company is helping to address the hidden crisis of chronic kidney disease.
 

Resources

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Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.
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The Future of MedTech: The Role of AI

Cognizant, in partnership with Microsoft, have interviewed 200 medtech decision makers across the UK, Ireland, France, Germany and the USA to find out about what the future holds. A responsible AI framework is going to be key. Read our report to learn more.
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Accelerating Timelines to Clinic with GPEx® Lightning

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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.
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Navigating the Path to Medication Adherence: Overcoming 8 Key Challenges

Navigating the Path to Medication Adherence: Overcoming 8 Key Challenges
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Switching Treatments: Pharma's Opportunity to Drive Action

Open up unexpected opportunities. This digital story offers pharma marketers proactive strategies for helping patients discover and switch to treatments, even if they aren’t actively looking to make a change.
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Accelerating Alzheimer's Therapy Innovation: The Power of Blood-Based Biomarkers

Blood-based biomarker testing presents a promising solution to improve access to critical early risk assessment along with a pathway towards accelerated clinical trials for Alzheimer's Disease.
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Why Biotech Sponsors Need Outside Support: IRB, IBC, DMCs, and EACs

When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions.
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HPV-based cervical cancer screening: Gaining insights in sample preference and cost-effectiveness.

Power non-invasive, self-sampling solutions using the Colli-Pee™️ first-void urine collection device. Learn more.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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