Biogen

The EC approved OPUVIZ 40 mg/mL solution for injection, a biosimilar referencing Eylea, developed by Samsung Bioepis. OPUVIZ, formerly SB15, treats neovascular AMD, macular edema secondary to RVO, DME, and myopic CNV. Samsung Bioepis and Biogen aim to expand access to vital biologic therapies, with OPUVIZ being their fifth biosimilar approved in Europe.

New Alzheimer's therapies like Kisunla and Leqembi face regulatory and access challenges, highlighting the need for balancing clinical rigor with patient convenience. Decentralised trials (DCTs) are crucial for Alzheimer's research, though their use has declined, with Eli Lilly leading in DCT adoption. Digital health technologies, including telemedicine and wearables, offer potential to enhance trial data quality and patient recruitment, but challenges remain in ensuring technology usability and data integrity.

The Global Cell and Gene Therapy Market is projected to reach USD 78 Billion by 2032, driven by regulatory approvals, technological innovations, and personalized medicine. North America leads with a 49.6% market share. Challenges include high costs and complex manufacturing. Recent developments include Novartis AG's FDA approval for KYMRIAH and Biogen Inc.'s collaboration with Scribe Therapeutics. The market is set for extensive growth, supported by strategic partnerships and ongoing R&D.

Alzheimer’s disease therapeutics market includes symptomatic treatments (cholinesterase inhibitors, NMDA receptor antagonists) and disease-modifying therapies (anti-amyloid monoclonal antibodies). Market growth driven by aging population, diagnostic advancements, and R&D investments. Market expected to grow from USD 5.5 billion in 2023 to USD 30.8 billion by 2033 at 18.8% CAGR. Major companies include Biogen, Merck, GSK, Novartis, Johnson & Johnson, Bristol Myers Squibb, Sanofi, Pfizer, Teva Pharmaceutical, and AbbVie, each with strategic initiatives and collaborations in Alzheimer’s research.

The article discusses the implementation of SSR (Server-Side Rendering) using a JavaScript bundle, specifically mentioning the entry point '/bundles/v1/views/latest/SSR-service-entry.c49d8207ea51fe4b43e4.js'.

RFK Jr.'s anti-vaccine rhetoric has led to preventable deaths and illnesses, but he correctly criticizes pharmaceutical industry corruption. Patent monopolies allow inflated drug prices, incentivizing misleading claims and FDA approval manipulation. Alternative funding mechanisms, like upfront government research payments, could reduce corruption and save billions on drug costs.

Roche's Evrysdi leads SMA market with 16,000+ patients; Biogen's Spinraza faces revenue decline but sees growth potential; higher-dose Spinraza shows efficacy; Novartis' Zolgensma grows 3%; Roche explores combo therapy for Evrysdi.

The EU approves Leqembi, a drug to delay Alzheimer's onset, for patients not in advanced stages, despite initial rejection due to risk of brain bleeding. The UK also approved it under the name lecanemab, with a controlled availability program to manage risks.

Eisai and Biogen received a positive CHMP opinion recommending approval of lecanemab, an Aß monoclonal antibody for early Alzheimer’s disease in ApoE e4 non-carriers or heterozygotes. Lecanemab selectively binds to Aß aggregates, reducing protofibrils and plaques. The CHMP's positive opinion was based on phase 3 Clarity AD trial data, showing significant reduction in clinical decline. Lecanemab has been approved in several countries and is under review in others.