Januvia's fast development and successful launch exemplifies Merck's new biomarker-based R&D operation and its focused "one Merck" strategy. But the drug also provides an ideal case study of why doing everything right in primary care brings with it extraordinary risks: the key elements of Januvia's success -- blazing speed through development and the extraordinary safety profile on which its commercial triumph depends -- also define its most dangerous commercial liabilities.
By Roger Longman
Five months into its commercial life, Januvia has been the most successful anti-diabetic drug launch ever. Measured solely by returns,...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Against a backdrop of shifting trade policies, the end of multilateral market approaches and renewed focus on supply chain resilience, medtechs are doubling down on innovation in products and processes – using AI – and keeping unmet needs and outcomes in the center of the target.
While biopharma companies experiment with genAI, agentic AI is rapidly shifting the work paradigm towards one of autonomous digital workers that can handle entire process flows.