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The Weight-Loss Gold Rush: Legal and Regulatory Implications
Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses:
- Top legal and regulatory concerns for investors considering when financing companies developing or marketing GLP-1 drugs
- How the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs
- What needs to be done for GLP-1s to be covered
- Steps companies developing weight-loss medications should take to ensure responsible and ethical practice
- Advice for investors and financiers who are considering entering the weight-loss medication market
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
