AstraZeneca

AstraZeneca's Imfinzi sBLA for muscle-invasive bladder cancer (MIBC) receives FDA priority review, with decision expected Q2 2025. Based on phase III NIAGARA study, Imfinzi showed reduced risk of disease progression/recurrence and death in MIBC patients.

Stefano Romeo's research identifies two types of steatotic liver disease: one aggressive, affecting the liver, and another linked to cardio-renal-metabolic syndrome. Genetic tests reveal 27 new variants, enabling risk score determination for tailored treatments. Parallel studies using unsupervised clustering confirm these findings, advancing precision medicine.

Datopotamab deruxtecan granted Breakthrough Therapy Designation by FDA for EGFR-mutated NSCLC, based on TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials. This marks the first BTD for datopotamab deruxtecan and the twelfth for Daiichi Sankyo's oncology pipeline.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation (BTD) in the US for treating EGFR-mutated non-small cell lung cancer (NSCLC) patients who progressed after EGFR-TKI and platinum-based chemotherapy. The BTD was based on Phase II and III trial data, marking the first BTD for datopotamab deruxtecan.

Datopotamab deruxtecan (Dato-DXd) received Breakthrough Therapy Designation in the US for treating EGFRm NSCLC patients progressing after EGFR-TKI and platinum-based chemotherapy, based on TROPION-Lung05 and TROPION-Lung01 trial data.

The 2024 Nobel Prize in Chemistry recognizes AI's transformative impact on protein science, awarding Demis Hassabis and John Jumper for AlphaFold2 and David Baker for computational protein design. AlphaFold2 predicts protein structures with near-experimental accuracy, revolutionizing drug development and biomedical research. Baker's Rosetta algorithm designs new proteins from scratch, opening possibilities for new medical treatments and nanotechnology. This marks the first Nobel prize for an AI-enabled scientific breakthrough, highlighting AI's potential across scientific fields and its role in accelerating drug discovery and personalized medicine.

SkyQuest projects the cancer monoclonal antibodies market to reach USD 337.92 billion by 2031, with a CAGR of 18.4% (2024-2031). Factors driving growth include high cancer incidence, biotechnology advancements, and rising use of combination therapies and biosimilars. North America leads due to robust R&D investments, while blood cancer treatments dominate the market. Key players include AbbVie, Amgen, Merck, and Bristol-Myers Squibb.

FDA grants priority review to AstraZeneca's Imfinzi sBLA for muscle-invasive bladder cancer, supported by NIAGARA trial results. Imfinzi, combined with neoadjuvant chemotherapy, aims to delay recurrence and extend survival in MIBC patients.