Walking the Talk About Surrogate Endpoints
Quiz me this……….What is a surrogate endpoint, and what the heck do they have to do with a drug obtaining Accelerated Approval? People working in
June 24, 2025
Quiz me this……….What is a surrogate endpoint, and what the heck do they have to do with a drug obtaining Accelerated Approval? People working in
Global Pharma industry has been buzzing about the looming tariffs from the US being applied for everything from Hello Kitty chotchkie to, ‘say it ain’t
A recent Executive Order directing HHS to develop price targets for imported drugs has really stirred up the hornet’s nest. It is common knowledge that
The FDA recently approved a new treatment, Qfitlia (fitusiran) from Sanofi, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult
Oncology products continue to be the top products driving the pharma marketplace. They are among the most expensive and complex due to the numerous iterations
The FDA recently approved a therapy originally approved in 1983, Vykat XR (diazoxide choline) from Soleno Therapeutics, based on a breakthrough indication for the treatment
Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases
The past year has brought rough financial seas to Walgreens. As recently as this January we reported on Walgreens plans to possibly go private after closing
Today’s Report spotlights a relatively insignificant event in therapy distribution. We are talking about COSTCO, yes the warehouse retailer. What they did is simply add a new
The FDA recently approved one… no wait, two… no wait, is it really one times two denosumab biosimilars…..?? The/these approval/s include Ospomyv (denosumab-dssb) and Xbryk (denosumab-dssb)…
