BAYER AG

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Pharmaceutical companies conduct most clinical trials in countries where they plan to market products, often neglecting low and middle-income countries (LMICs), particularly in sub-Saharan Africa. This exclusion limits access to life-saving treatments and therapies for patients in these regions. The Access to Medicine Foundation report highlights a gap in product registration in Africa, with 43% of innovative products approved in the past five years not registered in any African countries. The report calls for pharmaceutical companies to prioritize equitable access and work with local partners to build research capabilities in LMICs.

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, has been filed for review by the European Medicines Agency for potential EU marketing approval.

The Brain Tumor Therapeutics Market is projected to grow from USD 3.28 billion in 2024 to USD 5.28 billion by 2030, driven by advances in healthcare technologies and increased investment in oncology research. Key areas explored include market penetration, development, diversification, competitive assessment, and product innovation. Challenges include high R&D costs and regulatory hurdles. Opportunities lie in personalized medicine and novel drug delivery systems.

Vivo, developed by OmniScience, won the CNS Summit Innovation Showcase for its ability to streamline clinical trial data accessibility and support actionable insights. The platform's genAI capabilities enable teams to make informed decisions, reducing trial timelines and increasing success rates.

BridgeBio’s Attruby, an oral drug for transthyretin amyloid cardiomyopathy (ATTR-CM), has been approved by the FDA, priced at $18,759.12 for a 28-day supply. It significantly improves survival and reduces heart disease-related hospitalizations but lacks a mortality benefit. BridgeBio partners with Bayer for European marketing and AstraZeneca’s Alexion for Japan. Analysts predict limited uptake due to Pfizer’s established Vyndaqel, but potential for $2.5 billion in global sales by 2035.

BridgeBio Pharma's acoramidis (Attruby) wins FDA approval for treating ATTR cardiomyopathy, competing with Pfizer's tafamidis. Attruby, a near-complete TTR stabilizer, aims to reduce cardiovascular death and hospitalization. Despite initial trial setbacks, 30-month data supported approval, positioning Attruby as the first oral stabilizer with near-complete stabilization claims. BridgeBio estimates a $15-20 billion market, dominated by Pfizer, with Alnylam and AstraZeneca also entering the space. Attruby's pricing is competitive but above cost-effectiveness benchmarks, with ongoing European review and a Bayer licensing deal.

BridgeBio Pharma's Attruby™ (acoramidis) receives FDA approval for treating ATTR-CM, reducing cardiovascular death and hospitalization. The ATTRibute-CM Phase 3 study showed significant benefits, with Attruby stabilizing Transthyretin (TTR) and improving patient outcomes. BridgeBio shares surged 25% post-approval. The company plans global expansion, with Europe, Japan, and Brazil as next targets. Scotiabank analyst Greg Harrison raised BridgeBio's price target to $48.00.

FDA approves BridgeBio Pharma's Attruby, an oral TTR stabiliser for ATTR-CM, aiming to reduce cardiovascular deaths and hospitalisations. Attruby is the first with near-complete TTR stabilisation specified in its label, triggering a $500m payment to BridgeBio. The ATTRibute-CM Phase III trial, enrolling 632 subjects, met its primary endpoint with a win ratio of 1.8, showing significant treatment effects. BridgeBio plans global approvals, starting with Europe, Japan, and Brazil.