FDA cleared the single pill combining conjugated estrogens with bazedoxifene, a novel selective estrogen receptor modulator, for two indications but issued a “complete response” letter for use in vulvar and vaginal atrophy.
FDA approval of a dual hot flashes/osteoporosis indication for Pfizer Inc.’s Duavee (conjugated estrogens/bazedoxifene) gives the big pharma a novel combination pill that hits two needs for the same target population of postmenopausal women.
It also creates an opportunity for Pfizer to try to recapture the type of broad use once enjoyed by Wyeth’s Premarin/Prempro hormone replacement therapy franchise, sales of which fell dramatically in
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.
Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.
Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.
A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.
New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.
