Amgen, Inc.

Semaglutide shows promise in treating osteoarthritis, potentially paving the way for FDA approval. Ozempic and Wegovy, both semaglutide-based drugs, are now listed as available by the FDA, potentially impacting compounding pharmacies. CRISPR gene editing continues to advance with notable researchers like Alexis Komor and Patrick Hsu. AstraZeneca's top executive in China is under investigation. A small study indicates TMS may slow Alzheimer's progression.

The FDA extended the PDUFA target action date for sotorasib (Lumakras) in combination with panitumumab (Vectibix) for metastatic colorectal cancer with KRAS G12C mutations to January 17, 2025, to review supplemental data. The extension follows positive results from the phase 3 CodeBreaK 300 trial, which showed improved progression-free survival with sotorasib plus panitumumab compared to standard care.

Amgen reports Q3 2024 financial results: total revenues up 23% to $8.5 billion, GAAP EPS increased 62% to $5.22, non-GAAP EPS up 13% to $5.58, driven by strong product sales and pipeline investments.

Amgen to release biosimilar of Regeneron's Eylea after U.S. appeals court ruling, despite Regeneron's patent infringement claims. Pavblu aims to provide affordable treatment for eye diseases.

The FDA accepted a BLA for HLX14, a biosimilar of denosumab, based on comparative quality and clinical studies. HLX14 met primary endpoints in a phase 3 trial, showing efficacy and safety in osteoporosis treatment. In March 2024, the FDA approved two denosumab biosimilars from Sandoz, marking the first approvals for biosimilars of Prolia and Xgeva.

Global exosome market to grow at ~20% CAGR by 2030, driven by chronic disease incidence, diagnostic improvements, and personalized medicine interest. North America leads, with key players like Danaher and Thermo Fisher Scientific. Notable developments include Aruna Bio's US patent for neural exosomes and EXO Biologics' EUR 16 million Series A funding.

Tanvex BioPharma appoints Stephen Lam as CEO, effective September 5, 2024. Lam will oversee integration with Bora Pharmaceuticals, driving strategic initiatives and managing global CDMO operations. With over 35 years of industry experience, Lam aims to expand Tanvex's global presence and accelerate growth.

Respiratory drug Fasenra, developed by AstraZeneca, has seen success in treating eosinophilic asthma and EGPA, with ongoing trials for COPD targeting patients with high eosinophil counts. Dr. Donna Carstens highlights the shift from 'treat-to-fail' to 'treat-to-target' in respiratory medicine, emphasizing the importance of precision and guideline-driven approaches.

Aprogen plans to focus on developing a new double receptor drug for degenerative arthritis, aiming for clinical trials after preclinical success with over 100 monkeys. The drug, a bispecific receptor antibody, could fundamentally treat arthritis lesions, with promising results in beagle dogs. Expected to attract global pharmaceutical interest, the market for advanced biopharmaceutical treatments is predicted to grow significantly.

Ideaya Biosciences presents phase 1 expansion data for IDE397, a potential first-in-class MAT2A inhibitor, in MTAP-deletion urothelial cancer and non-small cell lung cancer at ENA 2024, showing clinical efficacy and a manageable safety profile. The company plans to advance IDE397 as a monotherapy and in combinations, including with Trodelvy in urothelial cancer and AMG 193 in NSCLC.