Fulcrum dystrophy drug fails ph. 3

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Today’s Big News

Sep 12, 2024

Moderna targets $1.1B in R&D spending cuts, drops 5 programs amid profitability pressures


Sanofi pays $110M upfront for late-stage radioligand therapy, setting up rivalry with Novartis


Sanofi's $80M bet on Fulcrum's dystrophy drug ends in phase 3 failure after 4 months


GSK's mRNA flu vaccine finally overcomes tricky B strains in phase 2 trial


Oncternal folds all clinical trials after lackluster data drop, patient death


Lilly delivers one-two punch with 2nd tranche of positive data on weekly insulin candidate 


F2G raises $100M to fund 2nd attempt to get new antifungal class to market


Vironexis exits stealth with $26M, debuts rare disease gene therapies 


Cancer trials improperly exclude, underdose patients with common non-white blood type, study finds

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

 

Featured

Moderna targets $1.1B in R&D spending cuts, drops 5 programs amid profitability pressures

Moderna has vowed to cut annual R&D spending by $1.1 billion by 2027. The decision to shrink the budget by more than 20% follows commercial setbacks that have persuaded the biotech to take a “more selective and paced approach” to drug development.
 

Top Stories

Sanofi pays $110M upfront for late-stage radioligand therapy, setting up rivalry with Novartis

Sanofi has made a late entry to the radioligand party, paying 100 million euros ($110 million) upfront for global rights to a neuroendocrine tumor treatment that is nearing a filing for approval.

Sanofi's $80M bet on Fulcrum's dystrophy drug ends in phase 3 failure after 4 months

Just four months after Sanofi bet $80 million upfront on Fulcrum Therapeutics’ losmapimod, the program has ended in a phase 3 failure.

GSK's mRNA flu vaccine finally overcomes tricky B strains in phase 2 trial

After an initial defeat against the biggest barrier to mRNA flu vaccines—namely, B strains of influenza—GSK has returned with a reformulated candidate that has delivered the goods in the all-important population of older adults.

Oncternal folds all clinical trials after lackluster data drop, patient death

Cancer biotech Oncternal Therapeutics is folding all its clinical trials and laying off staff, turning its energy toward exploring strategic alternatives such as asset sales, a merger or acquisition.

Lilly delivers one-two punch with 2nd tranche of positive data on weekly insulin candidate

Lilly revealed that its weekly insulin candidate efsitora alfa met its primary endpoints for reducing the A1C measure of blood sugar across two more trials in the company's five-study phase 3 development program.

F2G raises $100M to fund 2nd attempt to get new antifungal class to market

After F2G’s first attempt to get a brand-new class of antifungal to market was derailed by the FDA, the U.K.-based biotech has secured $100 million in fresh funding to bankroll another push towards commercialization.

Vironexis exits stealth with $26M, debuts rare disease gene therapies

Vironexis Biotherapeutics has unveiled with $26 million and a clinical-trial-ready gene therapy that has already nabbed FDA fast track and rare pediatric disease tags.

Cancer trials improperly exclude, underdose patients with common non-white blood type, study finds

Hundreds of millions of people who live in, or are descended from, regions where the malaria-causing protozoan Plasmodium vivax is prevalent have inherited a unique blood type that evolved to prevent malaria infection. People with the Duffy null phenotype—who are primarily of African and Middle Eastern descent—have red blood cells that lack a surface protein called the Duffy antigen, which is what P. vivax uses to infect cells.

FDA slams AbbVie for misleading claims in Serena Williams ad for migraine drug Ubrelvy

The FDA has faulted AbbVie’s promotion of the migraine drug Ubrelvy, calling the company out for an ad featuring Serena Williams that went out of bounds with claims about how quickly the product relieves symptoms.

House Republicans stand firm on association health plans

House members voted in support of association health plans, the latest development in a yearslong battle that some say is an attempt to weaken the Affordable Care Act.
 
Fierce podcasts

Don’t miss an episode

A look at flu vaccine manufacturing and supply in the post-pandemic era

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines.
 

Resources

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Overcoming drug development hurdles with phase-appropriate technology transfers

Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market.

Whitepaper

Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
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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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Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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