Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at Roche’s $50 billion injection into the US pharma production scene, Biolinq’s efforts in expanding and commercializing its glucose biosensor, FDA’s clearance for Click Therapeutics’ digital migraine prevention tool, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
FDA Authorizes Click Therapeutics’ CT-132 for Migraine Prevention
The U.S. FDA authorized CT-132, a prescription digital therapeutic from Click Therapeutics, for the prevention of episodic migraines. Delivered via smartphone app, CT-132 showed reductions in monthly migraine days in a randomized, sham-controlled clinical trial and improved migraine-related quality of life. Approval came through the FDA’s de novo pathway, confirming its clinical validity. CT-132 addresses brain hypersensitivity by modifying behavioral responses to triggers and shows benefits even in patients using CGRP inhibitors. This marks Click’s first neurological and pain-focused approval. The company recently completed a Series C funding round led by Dassault Systèmes and its subsidiary, Medidata Solutions.
Orforglipron Matches Injectable GLP-1 Therapy in Phase 3 Diabetes Trial
Eli Lilly’s oral GLP-1 receptor agonist, orforglipron, met its primary efficacy endpoint in a 40-week Phase 3 trial, demonstrating A1C reductions of 1.3% to 1.6% compared to 0.1% for placebo. Weight loss ranged from 4.7% to 7.9%, with the highest dose group losing an average of 7.3 kg. Results were comparable to those seen with Novo Nordisk’s injectable semaglutide. Reported adverse events included diarrhea (up to 26%), nausea (18%), and indigestion (20%). This Phase 3 trial is part of a broader clinical program, with obesity trial results expected in late 2025 and regulatory submissions planned for obesity and Type 2 diabetes.
GSK’s Blenrep Gains U.K. Approval for New Multiple Myeloma Combinations
The U.K.’s MHRA approved GSK’s antibody-drug conjugate Blenrep (belantamab mafodotin) in combination with either bortezomib and dexamethasone or pomalidomide and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior therapy. The approval is based on late-stage clinical trials showing improvements in progression-free and, in some cases, overall survival compared to standard care. Blenrep was previously withdrawn globally in 2022 after failing to outperform existing therapies as a monotherapy. Regulatory reviews for the new combinations are ongoing in 14 other countries, with GSK anticipating additional approvals later in 2025.
Roche Announces $50 Billion U.S. Investment Amid Trade Policy Shifts
Roche announced a $50 billion investment over five years to expand U.S. drug production facilities and build new ones focused on obesity medications, gene therapies, and glucose monitoring devices. The plan includes a gene therapy site in Pennsylvania, an AI research center in Massachusetts, and upgrades to facilities in Kentucky, Indiana, New Jersey, Oregon, Arizona, and California. This move comes as U.S. trade policies threaten global commerce, prompting Roche and peers like Johnson & Johnson and Eli Lilly to collectively pledge over $160 billion in U.S. manufacturing. Roche’s expansion also seeks to establish a drug export surplus.
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