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Today’s Big News

Jul 18, 2024

J&J drops Addex-partnered epilepsy drug after reviewing failed phase 2 trial data

‘Not prudent’ for Novartis to join GLP-1 obesity race as late-runner, says CEO

FDA wrecks Agenus’ accelerated approval plan, triggering push to partner cancer combination

Exscientia pays $20M for full control of CDK7 drug, plans breast cancer combo trial

In a first, patients with autoimmune diseases respond to allogeneic CAR-T treatment

Featured

J&J drops Addex-partnered epilepsy drug after reviewing failed phase 2 trial data

By James Waldron

After mulling over the data from a failed phase 2 trial, Johnson & Johnson has decided to halt development of its Addex Therapeutics-partnered epilepsy drug, Fierce Biotech has learned.

‘Not prudent’ for Novartis to join GLP-1 obesity race as late-runner, says CEO

By James Waldron

The pharma has put “a lot of thought into” whether Novartis could play a role in the obesity space, Vas Narasimhan explained.

FDA wrecks Agenus’ accelerated approval plan, triggering push to partner cancer combination

By Nick Paul Taylor

The FDA has scotched Agenus’ plans to seek accelerated approval for a colorectal cancer combination, prompting the biotech to look into partnering to fund the phase 3 required to reach the market. Shares in Agenus fell 38% to around $11 in premarket trading.

Exscientia pays $20M for full control of CDK7 drug, plans breast cancer combo trial

By Nick Paul Taylor

Exscientia has taken full ownership of its oral CDK7 inhibitor candidate, buying out partner GT Apeiron for $20 million. The AI-enabled biotech plans to advance the molecule into a breast cancer combination trial.

In a first, patients with autoimmune diseases respond to allogeneic CAR-T treatment

By Darren Incorvaia

In a first, three patients with autoimmune diseases have responded positively to allogeneic CAR-T therapy. The study, conducted in China and published in Cell on July 15, is the first sign of the potential of allogeneic CAR-T therapies in treating autoimmune diseases, according to William Blair analysts.

Regulation concerns keep non-animal models out of R&D: survey

By Helen Floersh

Despite an FDA green light for the use of animal testing alternatives in drug development, regulatory concerns may be keeping the industry from embracing them, data collected by the R&D nonprofit Pistoia Alliance suggests.

Argenx posts J&J-rivaling Sjögren's data, massively upscales Vyvgart patient population at R&D day

By Fraiser Kansteiner

Even as argenx begins to chart a course toward a future beyond Vyvgart, the company’s flagship FcRn inhibitor still has plenty of tricks in store for the remainder of the decade.

AstraZeneca skewered by marketing watchdog over repeat offense

By Nick Paul Taylor

AstraZeneca has an unwanted hat trick of breaches of the U.K. pharma marketing code. The drugmaker completed the set after someone noticed the same compliance breach in two earlier cases, prompting the PCMPA to rule the company had brought discredit on the industry.

PhRMA doubles down on pricing attack, targeting shared ownership of insurers and PBMs in new ad

By Nick Paul Taylor

PhRMA’s smarmy avatar for the alleged avarice of pharmacy benefit managers (PBMs) is back in a fresh attack ad. And this time there’s two of him, enabling the trade group to blast insurance companies and their PBMs at the same time.

Suki brings AI scribes to community health centers with limited cash flow

By Emma Beavins

Suki AI, an ambient scribe solution, says community health centers are able to afford Suki, unlike other AI solutions on the market. Stakeholders have wondered if the healthcare AI revolution will benefit small practices. Suki aims to make inroads in that market.

Fierce podcasts

Don’t miss an episode

A look at Big Pharma’s top-paid CEOs

In this week's episode of "The Top Line," Fierce Pharma’s Eric Sagonowsky and Fraiser Kansteiner discuss Fierce’s annual special report, “Big Pharma's 10 highest-paid CEOs.”

Fighting maternal and infant health inequities

The best biopharma M&A deals

Resources

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The “Best Practice Organization” & Its Importance for Success in Today’s Biopharma Industry

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