News
Ecnoglutide, which Pfizer licensed from Sciwind Biosciences, is already approved in China for type 2 diabetes mellitus, and a marketing application for weight loss has been accepted by regulatory authorities in the country.
FEATURED STORIES
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
The necessity of delivering medicine days after it’s produced drives decisions about where to build facilities and how to ship radioactive materials to healthcare providers.
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
AceLink is advancing a small-molecule treatment option for Fabry disease that could provide a more convenient alternative to the current enzyme replacement therapy standard.
Novo Nordisk’s bispecific antibody Mim8 prevented bleeding events and caused no adverse safety events in the Phase III FRONTIER3 trial. The company plans to file for approval this year, hoping to compete in the hemophilia A space with Roche’s blockbuster Hemlibra.
If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for non-opioid pain treatments that could help quell the still raging opioid epidemic.
Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
Alumis held its initial public offering in June last year, while Acelyrin debuted on the Nasdaq in mid-2023.
In a mid-stage study, the candidate itolizumab achieved 23.3% clinical remission rate at 12 weeks, numerically better than Humira’s 20% at the same time point.
According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far.