AstraZeneca

Global Organoids Market to grow at a CAGR of ~14% by 2030, driven by personalized medicine, organoid use in drug discovery, and cancer research. North America leads the market, with key players including Thermofisher Scientific Inc., StemCell Technologies Inc., and others. Organoids mimic human organs, aiding in disease modeling and drug testing, but face challenges like high costs and limited vascularization.

Fortress Biotech announces FDA approval of Emrosi for rosacea and potential approval of cosibelimab for cSCC, with financial results for Q3 2024 showing a net loss of $15 million.

A new BLA for Dato-DXd in EGFR-mutated NSCLC was submitted, replacing the earlier nonsquamous NSCLC application, based on phase 2 and 3 trial data. This decision followed FDA feedback and aims for accelerated approval.

Amgen's MariTide linked to bone density loss, Lexeo Therapeutics gains FDA agreement for Friedreich ataxia gene therapy, AstraZeneca to invest $3.5B in U.S. facilities, Roche pays Flare Therapeutics $70M for oncology drug development, Novartis collaborates with Schrödinger for drug discovery, Centessa halts hemophilia B treatment development.

Syros Pharmaceuticals' phase III study for tamibarotene in MDS missed primary endpoint; Amgen's stock steady despite analyst report; Adaptimmune reports positive results for lete-cel; Daiichi Sankyo and Astrazeneca submit new BLA for lung cancer treatment; Apollo Therapeutics signs $938 million deal with Sunshine Lake Pharma; study identifies quiescent cancer stem cells in glioblastoma relapse; Modifi Biosciences acquired by Merck for up to $1.3 billion.

IgA nephropathy affects 25-50 per million annually, with 20–40% progressing to end-stage kidney disease. Diagnosed cases in the US are expected to reach 135,000 by 2030. Treatments include ACE inhibitors, ARBs, corticosteroids, and immunosuppressants. FDA-approved treatments are TARPEYO, FILSPARI, and FABHALTA. The IgA nephropathy market is projected to reach ~USD 4.1 billion by 2034, driven by novel therapies like Novartis’ Atrasentan, Otsuka/Visterra’s Sibeprenlimab, Vertex/Alpine’s Povetacicept, and others.

PreveCeutical Medical Inc. announces Dr. Mariya Georgieva as President of BioGene Therapeutics Inc., effective 11 November 2024, to advance siRNA therapy in diabetes and obesity.

AstraZeneca and Daiichi Sankyo submitted a new BLA to the FDA seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat EGFR-mutated NSCLC, based on Phase II TROPION-Lung05 trial results. The decision follows FDA feedback and withdrawal of a previous BLA. The therapy, a TROP2-directed ADC, aims to improve outcomes for advanced lung cancer patients.

Johnson & Johnson announced its combination drug, Rybrevant and lazertinib, extends progression-free survival in non small-cell lung cancer patients with a specific EGFR mutation. Approved in 2021 for a small NSCLC subset, J&J is testing this therapy against Tagrisso, aiming for first-line treatment status.

Merck & Co, Alexion, and AstraZeneca Rare Disease report positive Phase III KOMET trial results for Koselugo, showing statistically significant improvement in objective response rate (ORR) for adults with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN), with no new safety signals.