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U.S. Tuberous Sclerosis Drug Market Projected to Reach $1.25 Billion by 2030, Growing at 23.1% CAGR

• The U.S. tuberous sclerosis drug market is expected to grow from $237.2 million in 2022 to $1.25 billion by 2030, driven by FDA approvals of new treatments and increasing disease prevalence.
• FDA-approved treatments include Afinitor (everolimus) for patients aged 2 and above, approved in 2018, and Epidiolex (cannabidiol) for patients aged 1 and above, approved in 2020.
• mTOR inhibitors are gaining significant traction in treatment protocols, showing effectiveness for internal tumors and skin lesions, with FDA approval for treating lung complications like Lymphangioleiomyomatosis (LAM) in 2015.

FDA Approves Aduhelm: First Disease-Modifying Alzheimer's Treatment in Nearly Two Decades

• The FDA granted accelerated approval to Biogen's aducanumab (Aduhelm) as the first disease-modifying Alzheimer's treatment in nearly two decades, despite divided expert opinions on its clinical efficacy.
• Aduhelm, priced at $56,000 annually, works by reducing amyloid plaques in the brain and will require monthly intravenous infusions with comprehensive clinical and MRI monitoring for potential adverse effects.
• As part of the accelerated approval, Biogen must conduct a Phase 4 confirmatory trial, while experts view this approval as a potential catalyst for developing more effective Alzheimer's treatments targeting multiple pathways.

Oasis Diagnostics Receives Michael J. Fox Foundation Grant for Saliva-Based Parkinson's Test

• Oasis Diagnostics has been awarded a research grant from The Michael J. Fox Foundation to validate their non-invasive, saliva-based rapid test for Parkinson's disease detection and diagnosis.
• The company will collaborate with Dr. Charles Adler's team at Mayo Clinic in Scottsdale to study proprietary salivary biomarkers, with research suggesting that just three of 50 identified biomarkers can provide accurate diagnosis.
• The VerOFy® Rapid Test Platform could potentially transform Parkinson's diagnosis, offering a non-invasive alternative to current expensive and invasive diagnostic methods while potentially accelerating clinical trials of disease-modifying treatments.
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