Licensing

The goal of the pilot program is to allow American and European assessors the ability to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic/hybrid products.

Bio-Thera will maintain responsibility for development, manufacturing and supply of the biosimilar Stelara while Hikma will have exclusive rights to commercialize the product in the United States.

Biosimilar ustekinumab will provide a treatment of autoimmune and inflammatory diseases such as plaque psoriasis, Crohn's disease and ulcerative colitis.

This week, DSN is asking readers to weigh in on expanding pharmacists’ prescribing authority nationwide.

Keynote speakers include Montel Williams, Justin Patton, Monica Pearson, and Amelia Rose Earhart.

National Community Pharmacists Association CEO Doug Hoey, in a roundtable discussion with Health and Human Services Secretary Xavier Becerra, focused on four major priorities for independent pharmacies.

Sun Pharma will be able to manufacture and sell a limited quantity of generic lenalidomide capsules after March 2022, as well as an unlimited quantity beginning Jan. 31, 2026.

The newly-enacted law recognizes pharmacists as healthcare providers in Maine