AstraZeneca

Ascentage Pharma's NDA for lisaftoclax, a Bcl-2 inhibitor for r/r CLL/SLL, was accepted by China's NMPA with Priority Review, potentially making it the first domestically developed Bcl-2 inhibitor in China and the second globally. This follows a Phase II study showing efficacy and safety in Chinese patients with r/r CLL/SLL, addressing a significant unmet need in China where CLL/SLL incidence is rising.

New vaccine plants in Germany and the Netherlands aim to boost EU supply. AstraZeneca's Leiden factory received EMA approval, expected to distribute doses quickly. EU accuses AstraZeneca of contract breaches, with only 13 million doses delivered so far. EMA expects massive increase in AstraZeneca vaccine production in the EU. EU restricts exports to UK, Canada, and Australia. BioNTech Pfizer's Marburg plant approved, facilitating vaccine distribution. Moderna and Johnson&Johnson also expand production in the EU. EU aims to produce 2-3 billion doses by year-end.

FDA reviewing BLA for Dato-DXd, seeking accelerated approval for EGFR-mutated NSCLC. AstraZeneca and Daiichi Sankyo withdrew previous BLA for nonsquamous NSCLC based on TROPION-Lung01 phase 3 data. New BLA submission based on TROPION-Lung05 phase 2 data, supported by TROPION-Lung01 phase 1 and TROPION-PanTumor01 phase 3 findings. Updated findings to be presented at ESMO Asia 2024.

Canadian researchers are part of global efforts to test targeted alpha therapy, a new cancer treatment using radioactive alpha particles to kill cancer cells more effectively and with less damage to healthy tissue. Several therapies are in final stages of testing and could be approved by Health Canada within a few years. Potential applications include pancreatic, prostate, breast, and neuroendocrine cancers. Challenges include production of rare radioactive isotopes and high costs, with treatments expected to cost tens of thousands of dollars per dose.

EU authorities to decide on Sputnik V vaccine use in September; Bavarian PM Markus Söder urges EMA for swift approval. Despite EMA's ongoing review, Hungary and Slovakia use Sputnik V without its permission.

AstraZeneca signed an $18 million deal with Immunai, a NY-based AI company, to use their technology in cancer medication clinical trials. Immunai's CEO, Noam Solomon, reflects on the challenges and personal motivations behind starting the company, emphasizing the importance of AI in improving patient outcomes and drug development processes.

CytomX Therapeutics faces challenges from supplier dependency, customer bargaining power, intense competition, and substitute therapies. Its success relies on the innovative PROBODY platform and strategic partnerships to navigate the competitive oncology market.

CytomX Therapeutics faces challenges from supplier dependency, customer bargaining power, competitive rivalry, and substitute therapies. Its success relies on the PROBODY platform and navigating these dynamics effectively in the oncology market.