New & Notable

Novo submits its next-gen obesity drug for FDA approval

Novo Nordisk has filed for FDA approval of its next-generation, combination obesity drug, CagriSema, with a review expected next year.

Recent mid-stage readouts reveal how the market for an oral weight loss drug could take shape.

— PharmaVoice

Elli Lilly has filed for FDA approval of its oral GLP-1 therapy, orforglipron, after another successful phase 3 study.

The agency’s moves to end animal testing are “not a fluke.” Here’s what drugmakers need to know about where it goes from here.

— PharmaVoice

— BioPharma Dive

— BioPharma Dive

A podcast for healthcare professionals seeking solutions to today's and tomorrow's top challenges. Hosted by the editors of Xtelligent Healthcare Media, this podcast series focuses on real-world use cases that are leading to tangible improvements in care quality, outcomes, and cost.

Guests from leading provider, payer, government, and other organizations share their approaches to transforming healthcare in a meaningful and lasting way.
View All Episodes

Eli Lilly lowers Zepbound costs amid rising calls for affordability

Lilly cuts prices for its weight loss drug Zepbound as the World Health Organization issues its first global GLP-1 obesity guidelines, urging expanded access and affordability.
WHO releases its first-ever GLP-1 weight-loss drug guidelines

GLP-1 drugs approved for weight loss can be combined with behavioral therapy as part of a long-term strategy in adults, the WHO says in new guidance.
Novo Nordisk's amycretin shows competitive phase 2 weight loss

After yesterday's setback, Novo Nordisk released mid-stage data showing oral and injectable amycretin led to 7.6% and 11.9% placebo-adjusted weight loss, respectively, in patients with type 2 diabetes.
Consumer confusion fuels risky online drug purchases, survey finds

Due to widespread misunderstandings, many U.S. adults are buying drugs, especially GLP-1 products, from online, unlicensed sellers, a new survey reveals.
Wegovy linked to liver health benefits at low levels of weight loss

Wegovy may improve liver injury and scarring in adults with MASH and moderate-to-severe fibrosis, even without significant weight loss, data shows.
FDA expands the National Priority Voucher program to oral GLP-1s

The FDA's second wave of National Priority Voucher recipients includes Novo Nordisk and Eli Lilly's oral GLP-1s, expanding the list to 15 products.

Blurring the line between GLP-1 compounders, counterfeiters

Weak regulatory oversight has allowed 503A compounding facilities to abuse customization rules, blurring the line between GLP-1 compounders and unregulated drug manufacturers.
Expanding clinical trial access through technology, support

Systemic barriers continue to restrict clinical trial access, but when deployed correctly, technology can provide patient–provider support and close interoperability gaps.
Will the FDA's green list end illegal GLP-1 compounding?

The FDA recently created a green list to regulate imported GLP-1 drug ingredients, yet experts say that weak enforcement could allow illegal compounding operations to continue.
Using AI to identify, expose online drug counterfeiters

Pharmaceutical companies are leveraging AI's advanced detection and enforcement tools to combat the online counterfeit drug market, protecting brand integrity and consumer safety.