Diabetes Drug Development Labelling 
Express Pharma
DECEMBER 2, 2024
The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. Novo Nordisk is leading the pack with four separate products, two apiece in Phase III and Phase II.
European Pharmaceutical Review
JUNE 12, 2025
These factors have created an ecosystem that allows MLM to address the challenges of drug development. The automatic generation of molecular structures accelerates drug candidate design by predicting target affinity. Through increased efficiency, MLMs can lower drug development costs.
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Putting Patients First Blog
JUNE 26, 2025
This step would ensure that real-world considerations, such as off-label uses and quality-of-life impacts, are factored into revised pricing decisions. Food and Drug Administration, FDA Patient-Focused Drug Development Guidance Series , March 21, 2025. 15 Inflation Reduction Act of 2022 , Pub. 117–169, 136 Stat.
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. The 505(j) pathway is how you get a multisource generic.
PharmaTech
JULY 4, 2025
Challener News Article Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise. Pharmaceutical companies have responded with growing investment in the research and development of novel eye treatments and drug delivery systems designed to address key challenges in ocular therapy. link] Roche.
Pharmaceutical Technology
JUNE 23, 2025
Eylea is approved in four indications in Europe: the treatment of ‘wet’ age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
BioPharma Dive
JUNE 11, 2025
Based on conversations with physicians, it “could be positioned well, and ahead of Augtyro,” he wrote, adding that Wednesday’s sell off in shares was “overdone on any potential launch and label optics concerns.” Sanofi’s $9.1 Sanofi’s $9.1
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