FDA panel opposes Spectrum's lung cancer drug

Today's Big News

Sep 23, 2022

Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial

AstraZeneca dumps Ionis drug despite hit in phase 2 cholesterol trial

FDA advisory committee votes down Spectrum's lung cancer hopeful in wake of efficacy concerns

Ferring's C. difficile drug overcomes skepticism to secure FDA committee nod

Aeon looks to phase 3 after botox-like treatment hits mid-stage trial goals for rare muscle disorder

Chutes & LaddersMaxwell Biosciences taps CMO, 2 other leaders as it aims to shed preclinical status

 

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Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial

Pfizer is finally nearly ready to resume dosing in its phase 3 hemophilia A gene therapy trial. Six months after the FDA lifted the clinical hold on the study, trial sites are set to resume enrollment with a view to restarting dosing in October.
 

Top Stories

AstraZeneca dumps Ionis drug despite hit in phase 2 cholesterol trial

Good, but not good enough. That is the verdict AstraZeneca reached after seeing phase 2b data on its Ionis Pharmaceuticals-partnered cholesterol drug ION449, which comfortably beat placebo but fell short of the bar for further development.

FDA advisory committee votes down Spectrum's lung cancer hopeful in wake of efficacy concerns

An FDA advisory committee has rejected Spectrum’s lung cancer hopeful Pozenveo, citing efficacy concerns.  

Ferring's C. difficile drug overcomes skepticism to secure FDA committee nod

Ferring Pharmaceuticals’ biotherapeutic passed an FDA committee vote despite some skepticism from a handful of members, setting up the asset for potential approval to treat C. difficile infection.

Aeon looks to phase 3 after botox-like treatment hits mid-stage trial goals for rare muscle disorder

The botulinum toxin family of treatments may be best known for aesthetic applications like Botox. But in Aeon Biopharma's case, its candidate ABP-450 hit its main goals in a phase 2 trial for a rare neck muscle disorder.

'The Top Line': How some Big Pharmas are bolstering their environmental sustainability efforts, the most expensive drug and more

This week on "The Top Line," we'll discuss how two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. We'll discuss their strategies and what we can expect for the future.

With Lilly's Mounjaro set for stardom, an Alzheimer's win would be 'icing on the cake': analysts

With Eli Lilly’s latest Type 2 diabetes launch and obesity hopeful in the running to become “the biggest drug ever,” an approval for donanemab—the company’s experimental antibody effort against Alzheimer’s disease—would simply be “icing on the cake” for investors. That's according to analysts at UBS.

Inspector general finds FDA's early COVID diagnostic policies came at a 'cost to test quality'

The watchdog office reviewed the FDA’s embrace of “regulatory flexibility” and its use of emergency use authorizations during the first months of 2020, at a time when no coronavirus tests were available anywhere in the country.

COVID-19 tracker: CDC flags new variant; Pfizer updates US donation deal

CDC data show that a new variant called BF.7 has doubled its incidence nationally over the last two weeks. Pfizer is updating a vaccine order with the U.S. Plus more.

A new global collaboration of scientists, clinicians and patients aims to hasten clinical trials on long COVID

The Long COVID Research Initiative aims to hasten research and clinical trials for long COVID by soliciting private backers and connecting researchers and clinicians with patients.

Chutes & Ladders—Maxwell Biosciences taps CMO, 2 other leaders as it aims to shed preclinical status

Maxwell Biosciences has added three new senior executives to its team as it aims to shed its preclinical status. 

Fierce Pharma Asia—Moderna's Japan plan; Takeda's cancer deal with Puma; Everest's new CEO

Moderna is considering building a manufacturing plant in Japan, its CEO says. Takeda has offloaded an unwanted cancer drug to Puma Biotechnology. Everest Medicines hired Gilead's former China head as its new CEO. And more.
 
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'The Top Line': How some Big Pharmas are bolstering their environmental sustainability efforts, the most expensive drug and more

This week on "The Top Line," we'll discuss how two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. We'll discuss their strategies and what we can expect for the future.
 

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