Eli Lilly and Co

The FDA agreed to reconsider its ban on private drug compounders selling compounded versions of Eli Lilly's weight loss and diabetes treatment drugs, following a lawsuit by the Outsourcing Facilities Association. The compounded versions are cheaper and crucial during shortages of Lilly's official drugs. The FDA's previous decision removed the active ingredient tirzepatide from the shortage list, affecting access for many obese patients. The FDA's reconsideration allows compounding pharmacies to continue providing these drugs, pending a review of ingredient supply.

The FDA agreed to reconsider its decision to bar drug compounders from selling their own versions of Eli Lilly's weight loss and diabetes drugs, allowing compounding pharmacies to continue providing cheaper alternatives while it reviews a potential shortage of the active ingredient, tirzepatide.

Eli Lilly's stock rose 1.18% to $921.435 after CEO announcement of potential Zepbound approval in Japan next year.

Eli Lilly's stock rose 1.55% to $924.82 after CEO comments on Zepbound's potential Japan approval in 2024.

Viking Therapeutics (NASDAQ: VKTX) develops obesity treatments, with its injectable candidate showing a 15% weight reduction in phase 2 and a pill candidate showing a 5.3% reduction in phase 1. Despite competition from Eli Lilly and Novo Nordisk, Viking could carve out market share due to high demand and potential buyout. Viking also explores treatments for NASH and X-ALD, with over $900 million in cash for program advancement.

Drug studies funded by manufacturers report 50% higher efficacy; Tamar Oostrom's research suggests sponsors selectively publish favorable trials, affecting drug use and patient outcomes.

GLP-1 receptor agonists have transformed the obesity market, leading to more decentralised clinical trials (DCTs) and advanced technologies like wearables and sensors. Novo Nordisk's semaglutide is a leader in obesity DCTs, with predictions of $42.8 billion in combined sales by 2030 for Ozempic and Wegovy. DCTs offer benefits like increased patient diversity but also challenges such as digital literacy biases. Telemedicine is the most used virtual tool in obesity DCTs, with continuous data collection improving quality of life measures. The future of obesity trials involves long-term follow-up studies and increased focus on reducing clinical events beyond weight loss.

Eli Lilly extends collaboration with KeyBioscience for dual amylin calcitonin receptor agonists (DACRA) development, targeting obesity. Lilly retains DACRA platform rights, including a new molecule entering Phase 2 studies. Lilly also invests $4.5 billion in a new Indiana site for advanced manufacturing and drug development.

Eli Lilly expects its weight-loss drug Zepbound to get regulatory clearance in Japan by mid-2025, joining the expanding weight-loss market dominated by Novo Nordisk's Wegovy. Zepbound, already approved in the U.S. and Europe, is a key growth catalyst for Eli Lilly's obesity treatment portfolio, with the company investing heavily in worldwide development.