Biosimilars Diabetes Drug Development 
Express Pharma
MARCH 16, 2025
First, advanced research and development (R&D) and biologics will be critical. To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. and Europe.
Pharmaceutical Technology
JUNE 23, 2025
Robert Barrie June 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Bayer’s Eylea is a heavyweight of the ophthalmic drug landscape, approved for a range of eye diseases. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.
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Pharmacy Times
JULY 22, 2025
Historically, the FDA has required preclinical testing in animals to obtain safety and efficacy data for investigational new drugs (INDs) before they can begin clinical testing in humans. The FDA plan seeks to leverage existing new technology in drug development. 3,6 REFERENCES FDA drug approval process infographic (horizontal).
Putting Patients First Blog
JUNE 26, 2025
CMS should draw on lessons from previous transitions, including biosimilar coverage rollouts and site-of-care policy shifts, to avoid known implementation pitfalls. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025. 15 Inflation Reduction Act of 2022 , Pub. 1818 (2022).
Pharmacy Times
JUNE 23, 2025
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.
pharmaphorum
JULY 24, 2025
Skip to main content Thursday 24 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)
Pharmacy Times
JULY 22, 2025
Emerging therapies—particularly targeted oncology treatments, medications for mental health conditions (including those under heightened controls such as psychedelics), cardiac care, and therapies for metabolic diseases, such as obesity and diabetes—often require genetically-informed dosing strategies. Accessed July 21, 2025. link] Roses AD.
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