AstraZeneca

AstraZeneca and Daiichi Sankyo submitted a new BLA for datopotamab deruxtecan for EGFR-mutated NSCLC, withdrawing a previous BLA for nonsquamous NSCLC. The decision was based on FDA feedback and trial data showing pronounced benefits for EGFR-mutated patients.

AstraZeneca and Merck report positive phase 3 KOMET trial results for Koselugo, a MEK inhibitor, in adults with neurofibromatosis type 1, showing significant improvement in objective response rate versus placebo. Koselugo, already approved for pediatric NF1, could extend benefits to adult patients with no approved treatments.

Regeneron and Sanofi's Dupixent gains FDA approval for COPD, becoming the first targeted therapy for the condition, with a Phase 3 trial showing reduced exacerbations and improved lung function.

Non-cystic fibrosis bronchiectasis market driven by rising prevalence, early diagnosis, and drug development. Over 15 companies, including Zambon SpA, Insmed, and AstraZeneca, are developing 15+ pipeline therapies. Key drugs in trials include Colistimethate sodium, Benralizumab, and Brensocatib.

Experts at Clinical Trials in Rare Diseases Europe 2024 and Clinical Data Management Innovation Europe 2024 will discuss innovative trial designs, real-world evidence, and AI integration in clinical data management, focusing on rare disease treatments and patient inclusivity.

AstraZeneca's Enhertu gains EMA approval for HER2-positive breast cancer, improving progression-free survival. Early detection in the U.S., Canada, and Europe boosts survival rates. The global breast cancer market, valued at USD 31.51 billion in 2024, is projected to reach USD 73.68 billion by 2032. Targeted therapies dominate, with North America leading due to advanced healthcare infrastructure and strong research funding.

The Cas nuclease market is forecasted to grow from $2.75 billion in 2023 to $6.56 billion by 2028 at a CAGR of 19.0%, driven by advancements in genome editing, increased biotechnology funding, and demand for personalized medicine.

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

Goodwin's two-part series on Greater China's life sciences sector highlights stable M&A activity in pharmaceuticals/biotech despite market fluctuations. Notable 2024 deals include Fosun's $1.71B acquisition of Shanghai Henlius Biotech, Johnson & Johnson's $850M purchase of Proteologix, and Novartis' acquisition of SanReno Therapeutics. Trends indicate a shift towards CAR-T cell therapies and large molecule/biologics, with medical devices also gaining significance. Factors driving recovery include regulatory changes, market readjustments, and the maturing of early-stage investments.

AstraZeneca and Daiichi Sankyo submitted a BLA to the FDA for accelerated approval of datopotamab deruxtecan (Dato-DXd) in previously treated, advanced EGFR-mutated NSCLC, based on TROPION-Lung05 Phase II trial results. The companies withdrew a previous BLA for Dato-DXd in advanced or metastatic nonsquamous NSCLC.