AstraZeneca

AstraZeneca's cancer drug Dato-DXd, acquired for up to $1 billion, failed to significantly improve overall survival in advanced breast cancer patients, following a similar setback in a lung cancer study, leading to a further decline in the company's share price.

FDA approves FluMist, a nasal spray flu vaccine for self or caregiver administration at home, offering a needle-free option for ages 2-49. FluMist, containing a weakened flu virus, protects against types A and B, with studies showing it's as effective as traditional methods. Available with a prescription, it will soon be offered by an online pharmacy for home delivery, alongside existing availability at doctors' offices and pharmacies.

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The FDA approved FluMist for self-administration by adults up to 49 years or caregiver administration for ages 2 to 17, making it the first self-administered flu vaccine. FluMist, containing weakened live influenza virus strains, is sprayed in the nose and requires a prescription for self- or caregiver administration, available through a third-party online pharmacy.

AstraZeneca and Daiichi Sankyo's experimental breast cancer drug, datopotamab deruxtecan, failed to extend survival in a Phase 3 trial, complicating its approval prospects despite delaying tumor progression. The drug, part of a lucrative alliance, faces a complex path to market in breast cancer, potentially giving Gilead's Trodelvy an advantage.

AstraZeneca's TROPION-Breast01 Phase III trial did not meet statistical significance in overall survival (OS) for datopotamab deruxtecan in HR-positive, HER2-low or negative breast cancer patients. However, the trial previously met its progression-free survival (PFS) endpoint with statistically significant and clinically meaningful improvement, published in the Journal of Clinical Oncology. The drug's safety profile remained consistent with lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy. AstraZeneca and Daiichi Sankyo will continue discussions with regulatory authorities based on these results.

EMA’s CHMP recommended AbbVie’s ovarian cancer drug Elahere for approval in the EU, based on the MIRASOL study showing a 35% reduction in tumor progression or death. The EC will review this recommendation, with a decision expected later this year.

Final OS analysis of TROPION-Breast01 trial shows datopotamab deruxtecan (Dato-DXd) did not significantly improve overall survival in pretreated HR+/HER2- breast cancer patients compared to chemotherapy. Dato-DXd did show significant PFS improvement and better PROs, with a consistent safety profile. The FDA accepted a BLA for Dato-DXd in April 2024, and final OS results will be presented and submitted for regulatory review.

FDA approves FluMist nasal spray flu vaccine for self-administration, first of its kind for home use, available from 2025 flu season. Not recommended for pregnant or immunocompromised individuals; prescription required.

AstraZeneca's breast cancer drug, datopotamab deruxtecan, failed to show 'statistical significance' in a Phase 3 trial, affecting patient survival compared to chemotherapy. The trial involved over 700 patients with inoperable or metastatic breast cancer. AstraZeneca plans to present the data to regulators, though approval is now less likely.