Roche and Regeneron Announce Multi-Billion Dollar Investments in US Manufacturing Amid Tariff Concerns
• Roche has committed $50 billion to expand its US operations over five years, including new manufacturing facilities and R&D centers, with plans to create over 12,000 new jobs nationwide.
• Regeneron is investing more than $3 billion in US operations through a partnership with Fujifilm Diosynth Biotechnologies, nearly doubling its large-scale manufacturing capacity in the country.
• These pharmaceutical investments come as President Trump continues to threaten sector-specific tariffs, with Roche stating it will eventually export more medicines from the US than it imports.
Supreme Court Questions Roche on High Pricing of SMA Drug Risdiplam in India
• The Supreme Court of India has issued a notice to F. Hoffmann-La Roche Ltd regarding the pricing of Risdiplam, a medication for Spinal Muscular Atrophy (SMA), questioning why it's more expensive in India than neighboring countries.
• The case involves a 24-year-old woman with SMA who challenged the high cost of treatment, with her counsel arguing that government intervention in Pakistan and China has made the same medication more affordable in those countries.
• The Court has requested information on Risdiplam pricing in neighboring countries and whether the drug manufacturer would consider supplying it at lower rates in India, with the next hearing scheduled for April 8.
Neurocrine Biosciences Appoints Dr. Sanjay Keswani as New Chief Medical Officer
• Neurocrine Biosciences has appointed Dr. Sanjay Keswani as Chief Medical Officer effective June 2, 2025, succeeding Dr. Eiry W. Roberts who served in the role for seven years.
• Dr. Keswani brings over 20 years of pharmaceutical industry experience as a physician-scientist with expertise across multiple therapeutic areas and will lead clinical development and medical affairs activities.
• Prior to joining Neurocrine, Dr. Keswani served as President and CEO of ImmunoBrain and held senior leadership positions at Hoffman La Roche and Bristol-Myers Squibb.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
FDA Approves Roche's Companion Diagnostic for HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Roche's PATHWAY HER2 (4B5) test to identify HER2-ultralow metastatic breast cancer patients for targeted treatment.
• This approval expands treatment options for approximately 20-25% of HR-positive, HER2-negative breast cancer patients with HER2-ultralow status.
• The DESTINY-Breast06 trial demonstrated that ENHERTU improved median progression-free survival compared to chemotherapy in HER2-low and HER2-ultralow patients.
• Roche's diagnostic test standardizes HER2 assessment, reduces errors, and helps clinicians make informed treatment decisions for improved patient outcomes.
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