| 03.01.22 | Pfizer’s C. diff vaccine flops phase 3; Intelli a showcases crucial durability data for gene editing therapy

Klicken Sie hier, um Fiercebiotech.com zu abonnieren

Laden...

2 jahre vor

Html
Text

Webinar: Convergence of Digital Health and Patient Support

Tuesday, March 8, 2022 | 10am ET / 7am PT

The healthcare ecosystem continues to expand with digital health, but do new avenues drive connection among patients? Learn how Medisafe is helping pharma organizations create greater patient connection, engagement, and better outcomes. Register now.

Editor’s Note: You may have noticed some more big changes to our Fierce Biotech website. Our new fierce makeover is designed to create a better experience for our readers. Learn more about the new look here.

Today's Rundown

Intellia now has the data for No. 1 unanswered gene editing question: Does it last? Editas shares boosted as patent office rules in favor of Broad's CRISPR patents 2021's top 10 clinical trial flops Sponsored: The Importance of the Patient in Advancing Care in Rare Diseases Pfizer fails phase 3 C. diff vaccine test but still spies possible path forward AbbVie bets $130M on UCB spinout, bagging early-phase Alzheimer's and depression prospect Gemini CEO out the door as 80% of staff laid off, strategic review gets underway Johnson & Johnson, Legend's CAR-T Carvykti enters myeloma ring with FDA nod FDA stresses the importance of regular checkups for aortic aneurysm implants Editor's Corner: Fierce Pharma gets a fierce makeover 2 new compounds might help intervene in Type 2 diabetes, a disease that's 'foxed scientists for generations' Moody's: Failure to close Change deal would diminish UnitedHealth's long-term growth Researchers detail structure of C. diff’s protective armor, potentially opening path for drugs to break the stubborn layer

Featured Story

Intellia now has the data for No. 1 unanswered gene editing question: Does it last?

By Annalee Armstrong

Intellia proved last year that gene editing can work in humans. But a lingering question was, for how long? Now, the biotech has the data to begin to answer that question.

Streamlined Microbiome Analysis Services for Any Venture

Never worry about capacity constraints for your direct-to-consumer testing with Zymo Research’s customizable Microbiome Sequencing Services. Save time & resources by outsourcing your services to experts in the industry. Speak with a scientist today.

Editas shares boosted as patent office rules in favor of Broad's CRISPR patents

By Annalee Armstrong

The U.S. Patent and Trademark Office has ruled in favor of the Broad Institute in a dispute over the patents around CRISPR gene editing technology, sending Editas' shares up.

2021's top 10 clinical trial flops

By Phil Taylor

Thousands of studies are registered each year in the U.S. alone, so there is always a vast array of disappointing results to choose from as we compile our top 10 clinical trial flops.

The casualties in the Clostridium difficile vaccine race are starting to pile up. Having been vaulted to the front of the queue by Sanofi’s failure, Pfizer has now missed the primary endpoint in its phase 3 trial.

AbbVie bets $130M on UCB spinout, bagging early-phase Alzheimer's and depression prospect

By Nick Paul Taylor

AbbVie is betting $130 million on an early-phase neuroscience play. The upfront outlay has given AbbVie ownership of Syndesi Therapeutics, a UCB spinout that recently began phase 1b clinical trials of its lead candidate SDI-118 in cognitive decline and depression.

Gemini CEO out the door as 80% of staff laid off, strategic review gets underway

By Kyle LaHucik

The CEO of Gemini Therapeutics exited Monday as the company laid off 80% of its staff, shifted priorities to a preclinical asset and began searching for a future.

Johnson & Johnson, Legend's CAR-T Carvykti enters myeloma ring with FDA nod

By Angus Liu

An FDA approval for Johnson & Johnson and Legend Biotech’s CAR-T therapy may be three months late, but it still came. Having watched first-in-class Bristol Myers Squibb stumble with supply during the roll-out, the two companies have devised a game plan to ensure a smoother launch.

FDA stresses the importance of regular checkups for aortic aneurysm implants

By Andrea Park

According to the FDA’s letter, complications from endovascular aneurysm repair devices could be detected much earlier—potentially reducing long-term mortality rates—if patients and physicians stick to a regular checkup schedule.

Editor's Corner: Fierce Pharma gets a fierce makeover

By Eric Sagonowsky

We’re excited to share the new Fierce Pharma website. Starting today, our site will feature an improved layout designed to be easier to read and navigate—and better serve your needs.

2 new compounds might help intervene in Type 2 diabetes, a disease that's 'foxed scientists for generations'

By Kyle LaHucik

Researchers at University of Leeds said they found two new compounds, known as molecule modulators, that might lead to new drug development options for Type 2 diabetes. The modulators help slow down and speed up the process that creates amyloid fibrils, which are associated with the disease's development.

Moody's: Failure to close Change deal would diminish UnitedHealth's long-term growth

By Heather Landi

If UnitedHealth Group's bid to acquire Change Healthcare is ultimately stopped by the Department of Justice, it would be credit positive for UnitedHealth because of the short-term beneficial effect on debt and leverage.

Researchers detail structure of C. diff’s protective armor, potentially opening path for drugs to break the stubborn layer

By Kyle LaHucik

Researchers said they were able to map the chain-mail-like structure of Clostridioides difficile's outer layer, potentially paving the way for new drugs that specifically target the superbug. The bacteria is one of multiple superbugs resistant to most antibiotics, which is becoming a growing concern as drug developers' pipelines don't match the threat, according to a recent BIO report.