Biogen

Remedy Pharmaceuticals announced significant improvements in ambulation with Cirara in Phase 3 CHARM trial for large hemispheric infarction, with ORs of 1.8 (p=0.01) in mITT population and 4.1 (p<0.01) in lesion volume <125mL patients, particularly with EVT.

TOFIDENCE (BAT1806/BIIB800) maintains comparable clinical efficacy, safety, and immunogenicity after switching from reference tocilizumab in TP2 (Week 24-48) for RA patients with inadequate MTX response, supporting its biosimilarity.

Biogen's DEVOTE study showed significant motor function improvements in infants with SMA using a higher dose regimen of nusinersen, prompting plans for regulatory approval.

Candid Therapeutics, a T cell engager startup, launches with $370m to develop antibody drugs for inflammatory diseases, inheriting two advanced bispecific antibodies from Vignette and TRC 2004. The company aims to selectively deplete B lymphocytes in autoimmune diseases, with CEO Ken Song projecting potential beyond Humira and Rituxan.

The EMA's refusal to approve lecanemab, a drug for early Alzheimer's, contrasts with its approval in multiple countries. Critics argue the EMA overestimated risks and underestimated benefits, despite manageable side effects. The EMA's exclusion of researchers with industry ties, seen as a conflict of interest, may hinder objective assessments and slow drug approvals.

The Global Monoclonal Antibodies Market is projected to grow from USD 279.8 billion in 2024 to USD 804.7 billion by 2033, at a CAGR of 12.5%. North America is expected to dominate with a 47.5% share in 2024, driven by strong healthcare infrastructure and high R&D investments. Oncology is projected to lead the application segment with a 46.2% share. Major companies include Roche, Novartis, Johnson & Johnson, Pfizer, and Merck.

Topline data from the DEVOTE study's Part B cohort showed that a higher dose of nusinersen met the primary endpoint of significant motor function improvement in treatment-naïve infants with SMA. The higher dose regimen, consisting of 50-mg doses followed by 28 mg every 4 months, demonstrated significant CHOP-INTEND score improvement compared to the approved 12-mg regimen. The higher dose was generally well-tolerated, with lower serious adverse events reported. Biogen plans to present further details at upcoming medical conferences.

Geron Corporation appoints Jim Ziegler as Executive VP, Chief Commercial Officer to lead global commercial strategy and drive growth of RYTELO™, effective September 9, 2024.

Biogen's Phase II/III trial of an enhanced Spinraza dosage regimen for SMA infants showed significant motor function improvements, potentially leading to regulatory approval and reshaping treatment frameworks.

Global Monoclonal Antibodies Market to reach USD 804.7 billion by 2033, growing at a CAGR of 12.5% from USD 279.8 billion in 2024. Dominated by North America, human-derived antibodies, and oncology applications, with key players including Roche, Novartis, and Johnson & Johnson.