Search Results

The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.

Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?

UniQure and REGENXBIO are both dealing with FDA setbacks for their respective gene therapies, as regulatory experts question the FDA’s decision-making processes; CBER director Vinay Prasad is under probe for allegedly fostering a toxic workplace; Sarepta CEO Doug Ingram is stepping down after several years of tumult at the top of the muscular dystrophy–focused company; and Eli Lilly again tops Novo Nordisk in a weight loss trial.

Merck is eyeing a quick review for its lipid-lowering drug candidate enlicitide, which in December was awarded a Commissioner’s National Priority Voucher.

The Hunter syndrome space suffered a setback in February when the FDA turned down REGENXBIO’s investigational gene therapy, raising urgent questions about whether competitor Denali Therapeutics can clear the agency’s bar next month.

Gilead continues its dealmaking spree in the sizzling hot space of I&I as Johnson & Johnson, along with partner Protagonist, notched an FDA approval for a new psoriasis drug. Plus, Aurinia Pharmaceuticals gets a new C-suite, FDA releases draft guidance on non-animal models and the CDC’s vaccine advisory committee is not being disbanded after all.

Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while Rhythm’s Phase 3 basket trial fails to find the beat; Eli Lilly warns of potential safety risks of taking compounded tirzepatide, and Novo Nordisk is hit with an FDA warning letter regarding adverse events potentially linked to Ozempic.

Days after FDA Commissioner Marty Makary appeared to malign uniQure’s AMT-130 in an interview with CNBC, the agency confirmed to the biotech that a sham surgery–controlled study is needed before submitting the gene therapy for approval.

Pfizer has a lofty goal for the CDK4 inhibitor atirmociclib, the New York pharma’s answer to Ibrance’s loss of patent protection next year. In 2025, Ibrance led Pfizer’s oncology portfolio with $1.04 billion in sales.