AstraZeneca

AstraZeneca's CAPItello-281 phase 3 trial showed significant improvements in radiographic progression-free survival (rPFS) with Truqap (capivasertib) combined with Zytiga (abiraterone) and ADT in PTEN-deficient de novo metastatic hormone-sensitive prostate cancer patients, compared to Zytiga and ADT alone. The trial, involving over 1,000 patients, marks the first AKT inhibitor combination to demonstrate benefit in this specific form of prostate cancer, with ongoing assessment for overall survival.

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.

AstraZeneca plans $3.5bn US investment by 2026 for R&D centre in Cambridge, MA, and biologics facility in Maryland, aiming to boost cell therapy and specialty manufacturing capacities, and create over 1,000 skilled jobs. This aligns with AZ's goal to reach $80bn revenue by 2030, driven by growth in oncology, biopharmaceuticals, and rare diseases, plus 20 new medicine launches.

DelveInsight's 'Crohn's Disease Pipeline Insight, 2024' report details 70+ companies developing 80+ therapies, including AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, and Bristol-Myers Squibb. Key therapies like MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, and Brazikumab are expected to impact the market. The report covers clinical trials, regulatory approvals, market dynamics, and therapeutic assessments by route of administration and molecule type.

DelveInsight's report on Crohn’s Disease Market Insights, Epidemiology, and Market Forecast-2034 details the market size, emerging therapies, and key companies like Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, Tillotts Pharma, Gilead Sciences, Galapagos NV, Boehringer Ingelheim, Celgene (Bristol Myers Squibb), Eli Lilly and Company, RedHill Biopharma, Arena Pharmaceuticals, Mesoblast, and others. The market size in 7MM was ~USD 9,000 million in 2023, expected to increase by 2034, with key therapies like ENTYVIO, STELARA, VELSIPITY, Zeposia, LY-3074828, RHB-104, and others expected to launch. Positive results for mirikizumab and TREMFYA were reported in 2024, and Dong-A-ST's Imuldosa received FDA approval as a biosimilar to Stelara.

Top global pharma companies excel in R&D, pipeline management, and capital allocation, leveraging AI, personalized medicine, and supply chain resilience. Leaders like Roche and Novo Nordisk face challenges in valuation, access vs. profitability, and innovation pipeline management, emphasizing the need for balanced strategies and portfolio diversification.

AstraZeneca's Phase III CAPItello-281 trial showed Truqap improved radiographic progression-free survival (rPFS) when combined with abiraterone and androgen deprivation therapy (ADT) for PTEN-deficient de novo metastatic hormone-sensitive prostate cancer. The combination also showed a promising trend towards improved overall survival (OS) compared to abiraterone, ADT, and placebo.

GCAR and AstraZeneca will evaluate AZD1390 in GBM AGILE trial for newly diagnosed glioblastoma, with recruitment starting Q2 2025. GBM AGILE, the first global adaptive platform trial for glioblastoma, aims to identify effective therapies through adaptive randomization. AZD1390, an ATM kinase inhibitor, showed preliminary efficacy and manageable safety profile in Phase I data.

Mirdametinib, a MEK1/2 inhibitor, showed significant improvements in health-related quality of life (HRQOL) in adult and pediatric patients with NF1-PN in the ReNeu trial, with sustained improvements in physical, emotional, social, and school/work functioning. The trial met its primary endpoint of overall response rate (ORR) and demonstrated a manageable safety profile.

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.