May 30, 2024

The need-to-know this morning

The U.S. government is nearing an agreement to bankroll a late-stage trial of Moderna's mRNA pandemic bird flu vaccine, according to the Financial Times.

testing

Trade group fights FDA's plan to regulate lab-developed tests

A group representing clinical labs across the U.S. sued the FDA yesterday over the agency's plan to regulate lab-developed tests. It's the first lawsuit challenging the new rule.

Tests made in labs have historically gone unregulated by the FDA, but as they have grown more complex, the regulatory gray area enabled unreliable tests to thrive and harm patients. Examples include Theranos' infamous blood tests, as well as misleading prenatal genetic tests.

Immunology

Early study on Biohaven's autoimmune drug disappoints

In a closely watched Phase 1 study, the highest dose of an experimental autoimmune drug developed by Biohaven reduced levels of the IgG autoantibody by 37%, a smaller magnitude of benefit than what investors were hoping to see.

The therapy, called BHV-1300, belongs to a new class of antibody medicines that shuttle harmful proteins to the liver so they can be removed from the body. Analysts wrote that, as of now, the Biohaven drug doesn't look as competitive as other products under development by Argenx and by Immunovant and Roivant.

digital therapeutics

Akili gets acquired after video game treatment flounders

Akili Interactive, maker of a video game designed to treat ADHD, announced it will go private in a merger with Virtual Therapeutics in a deal expected to net Akili's shareholders $34 million.

It's the latest development in a turbulent saga for Akili, one of the digital tech darlings that drew heavy investor interest during the Covid-19 pandemic. Akili got FDA approval in 2020 for a video game designed to treat pediatric ADHD, but despite several strategic pivots, the company failed to build a sustainable business model.

clinical trials

NIH-funded trials often miss diversity enrollment goals

Drugmakers have faced pressure to improve the diversity of participants they enroll in clinical trials, but it turns out NIH-funded studies may not perform all that better.

When academic researchers apply for NIH funding, they're required to explain how they would enroll participants who are representative of the affected patient population, but a new report finds that many NIH-funded trials often enroll fewer Black patients and other underrepresented racial groups than they plan to.

big pharma

The ASCO ad blitz

Get ready to be hit with drug marketing the moment you step off the plane in Chicago. It looks like Novartis got a head start on taking up the precious ad space on the the pillars in O'Hare airport — my colleague Bob Herman spotted this a week ago while traveling.

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