The need-to-know this morning

• Novartis shares were down in early trading after the company reported a drop in sales and operating profit in the first quarter, with generic competition hitting drugs like Entresto hard. The company affirmed its guidance for the year, with net sales expected to grow in the low single digits, and core operating profit forecasted to decline slightly.
• The FDA has taken further actions to withdraw the approval of Amgen's rare-disease drug Tavneos and remove it from the market. Tavneos was approved in 2021, but new information indicates the drug is ineffective and the application used to support approval contained "untrue statements of material fact," the FDA said. Amgen has refused to withdraw Tavneos voluntarily, insisting the drug is safe.

pharma

Lilly bets on next-gen gene editors with new deal

Eli Lilly this morning announced a deal with AI-focused biotech Profluent to develop new forms of gene editors potentially capable of inserting entire genes into patients.

Lilly did not disclose how much it will pay upfront, but said it could pay Profluent up to $2.25 billion in milestones payments.

Flush with cash from its obesity franchise, Lilly has been investing heavily in gene editing and has opened a new genetic medicine center in Boston.

Read more from STAT's Jason Mast.

obesity

Boehringer drug looks efficacious but more data needed

Boehringer Ingelheim said today that its obesity drug candidate that targets the GLP-1 and glucagon hormones led to 16.6% weight loss in a Phase 3 trial, when assuming patients remained on the drug for the whole study.

While that is a significant amount of weight loss, more data are needed to compare this drug, called survodutide, with other treatments.

Boehringer did not disclose the efficacy when looking at all patients, including those who discontinued. The company also said participants experienced gastrointestinal side effects similar to those seen with other GLP-1 drugs, but did not disclose specific adverse event or discontinuation rates.

A GLP-1/glucagon drug may find a competitive edge not necessarily in producing greater weight loss, but in helping patients with liver conditions. There are glucagon receptors in the liver, and targeting them is thought to help decrease hepatic fat. Boehringer is testing survodutide in two Phase 3 trials of patients with MASH, an advanced form of fatty liver disease.