AstraZeneca

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.

The AI in Biotechnology and Pharmaceuticals Market is rapidly evolving, driven by tech advancements like machine learning, NLP, and automation, enhancing drug discovery, personalized medicine, and healthcare delivery. Key players include Thermo Fisher Scientific, Boehringer Ingelheim, Bayer, Oracle, Eli Lilly, and Johnson & Johnson, among others. The market faces challenges like regulatory constraints and talent shortages but offers opportunities in emerging regions and personalized medicine.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

CALQUENCE plus venetoclax with obinutuzumab reduced the risk of disease progression or death by 58% versus standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukemia (CLL). CALQUENCE plus venetoclax demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy.