Welcome to the Autumn 2023 issue of Pharmafile!

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

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.

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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.

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.

Novo Nordisk and UNICEF have announced an extension to their long-term partnership aiming to prevent global childhood obesity, which is now deemed a public health crisis affecting millions of children worldwide.

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.

Exscientia has announced a new collaboration with Merck KGaA, Darmstadt, Germany, with a focus on the discovery of novel small molecule drug candidates for the treatment of various indications across oncology, neuroinflammation and immunology.

GSK and Save the Children have announced that they will be renewing their partnership for an additional five years.

Pharmanovia has announced that it will expand its neurology portfolio with the acquisition of a selection of central nervous system (CNS) brands from Sanofi.

Astellas pharma has announced that it is preparing to submit a planning application to build a new state-of-the-art facility at an estimated cost of €330m in tralee, county kerry, ireland.

Stefan Woxström at AstraZeneca considers the high rates of non-communicable diseases and how governments and healthcare systems can improve their treatments

Pharmafile speaks to Scott Curley about CVD, the impact COVID-19 had on the pharma industry specifically in relation to CVD and the next steps for cardiovascular treatment in the UK

Tina Backhouse from Theramex considers the issues with the current standard of women’s healthcare in the UK, and what steps need to be taken to improve this

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Alicia Staley from Medidata explores the need for diversity in clinical trials, especially in terms of gender diversity, and how this can improve outcomes of clinical trials

Vicky Qu at BioMap considers the use of artificial intelligence in immuno-oncology and how its use can improve conventional drug discover y processes

Lukasz Jaremko from King Abdullah University of Science and Technology, Saudi Arabia explains how using nuclear magnetic resonance to study the dynamics of epigenetic targets may enable drug development that does not kill but resets cancer cells to a benign state

Amy McKee from Parexel considers the need for diversity in oncology clinical trials in order to fully realise the potential of personalised medicine

Dr Mitchell Smith and Dr Julie Dodds tell Pharmafile about recent R&D in the field of blood cancers including follicular lymphoma

Professor Hendrik van Poppel talks to Pharmafile about new campaigns to improve prostate cancer screening, the current standard-of-care treatments and what obstacles still need to be addressed in treatment

All the biggest events over the next few months

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