This issue includes the latest news, as well as articles on Cardiovascular and Metabolic Diseases, Women's Health, and Oncology.

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Welcome to the autumn 2023 issue of Pharmafile! As the summer draws to a close, it is an ideal time to consider 2023 so far and where it might take us in the remaining months.

Welcome to the Autumn 2023 issue of Pharmafile!

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Pfizer has announced that the CDC Advisory Committee on Immunization Practices (ACIP) has recommended the company’s bivalent respiratory syncytial virus (RSV) vaccine, Abrysvo, for maternal immunisation.

Eli Lilly and Boehringer Ingelheim have announced that the FDA has approved Jardiance (empagliflozin) 10mg tablets to reduce risk of sustained decline in estimated glomerular filtration rate (EGFR), end-stage kidney disease, cardiovascular death and hospitalisation in adults with chronic kidney disease (CKD).

GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.

The Menarini Group and its subsidiary Stemline Therapeutics have announced that the European Commission (EC) has approved Orserdu (elacestrant) as a monotherapy for the treatment of post-menopausal women and men with oestrogen receptor (er)-positive, her2-negative, locally advanced or metastatic breast cancer (mbc) with an activating esr1 mutation who have experienced disease progression following at least one prior endocrine therapy.

AstraZeneca and Daiichi Sankyo have shared positive high-level results from the tropion-breast01 phase 3 trial, which showed datopotamab deruxtecan demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy in patients with inoperable or metastatic hormone receptor (hr)-positive, her2-low or negative breast cancer.

BioNTech and the Coalition for Epidemic Preparedness Innovations (CEPI) have announced a partnership to advance the development of mRNA-based vaccine candidates for the prevention of mpox.

Bristol Myers Squibb (BMS) recently held a research and development day in New York, US, in order to discuss the company’s R&D strategy and capabilities while providing insights into its pipeline and long-term growth plans.