Guardant preps for FDA advisory panel

Today’s Big News

May 13, 2024

Sanofi, Pfizer, AstraZeneca invest a combined €1.87B to bolster operations in France


Takeda pays AC Immune $100M upfront for Alzheimer's drug as phase 2 readout nears


Guardant Health preps for FDA advisory panel review of its blood-based colorectal cancer screening test


Boehringer partners with Cigna unit to push Humira biosimilar after slow launch 


In new letter to Defense Department, WuXi AppTec refutes claim of secret data transfer 

 

Featured

Sanofi, Pfizer, AstraZeneca invest a combined €1.87B to bolster operations in France

Sanofi has earmarked more than 1 billion euros ($1.1 billion) to increase its manufacturing capacity at three sites in France, while Pfizer ($540 million) and AstraZeneca ($394 million) halve also revealed significant investments in the country as part of its "Choose France" summit.
 

Top Stories

Takeda pays AC Immune $100M upfront for Alzheimer's drug as phase 2 readout nears

Takeda may be paring back its R&D pipeline in the name of efficiency, but the Japanese pharma has still found $100 million to ensure its clinical pipeline once again features an Alzheimer’s disease drug.

Guardant Health preps for FDA advisory panel review of its blood-based colorectal cancer screening test

The agency has scheduled an advisory panel meeting May 23 to help evaluate the company’s Shield test, which is seeking an in vitro diagnostic approval for screening people ages 45 and up.

Boehringer partners with Cigna unit to push Humira biosimilar after slow launch

Boehringer Ingelheim has enlisted support for its attempt to prise AbbVie’s fingers off the Humira money faucet, signing an agreement to provide Cigna’s private label distributor with biosimilar copies of the aging blockbuster.

In new letter to Defense Department, WuXi AppTec refutes claim of secret data transfer

Facing potential sanctions from the Department of Defense and a recent allegation that it had transferred a U.S. client's data to Beijing without consent, WuXi AppTec is again rebutting claims of its ties with Chinese authorities.

Merck halts phase 3 TIGIT trial after immune-mediated adverse events prompt discontinuations

Merck & Co. has bailed early on a phase 3 test of the anti-TIGIT antibody vibostolimab after a high rate of discontinuations rendered the trial's success unlikely. 

As Bristol Myers reveals trial failure, AstraZeneca's Imfinzi stays king in stage 3 lung cancer

Following AstraZeneca's setback in attempting to improve upon Imfinzi's efficacy in unresectable stage 3 lung cancer, a Bristol Myers Squibb endeavor has gone up in flames, as well. Now, market watchers are turning their attention to upcoming readouts from Merck & Co. and Roche.

Medtronic nets approval in Japan for pulsed field ablation system

The PulseSelect system aims to treat the world’s most common irregular heart rhythm, atrial fibrillation.

Fierce Biotech Layoff Tracker 2024: Takeda to shutter San Diego research site; Ginkgo plans 'reduction in force'

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. 

Sanofi pays $80M to add Roche-rivaling Fulcrum drug to phase 3 rare disease pipeline

Sanofi is betting $80 million upfront on a GSK castoff ahead of a phase 3 readout. Fulcrum Therapeutics took the other side of the deal, handing Sanofi ex-U.S. rights to a rare disease candidate that is leading Roche in a race to market.

Shionogi's antiviral comes up short in global COVID-19 trial

While much of the fanfare around COVID-19 treatments has dissipated, Shionogi has continued to press on in hopes that its Japan-approved protease inhibitor ensitrelvir could compete on a global stage. But a clinical misfire unveiled Monday has likely put a damper on those plans, at least in the U.S.

Bayer taps ex-NFL star Julian Edelman to lead One A Day social campaign tackling wellness pseudoscience

Social media is full of so-called wellness “hacks” that range from the weird but harmless to the downright damaging—and now, Bayer is taking to its own online feeds to battle that misinformation.
 
Fierce podcasts

Don’t miss an episode

A series on advancements in cell & gene therapy manufacturing

This week’s episode of “The Top Line,” kicks off a series diving into the latest advancements in cell and gene therapy manufacturing. 

 

Resources

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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.
 

Industry Events

Drug Development Boot Camp® VIRTUAL | Spring 2024

April ‌10-11, ‌2024

On Helix

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

 

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