Moderna, a US-based biopharmaceutical company with an expertise in messenger RNA (mRNA), has announced updates in the two years since it signed a ten-year partnership with the UK Government.

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Private medical device and artificial intelligence (AI)-led company, BrightHeart, has revealed two studies which show an improvement to pre-natal care through the use of AI technology which received clearance from the US Food and Drug Administration (FDA) in November 2024.

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Page 14 – The future of pharma: how AI will reshape drug development and patient care in 2025

Welcome to the first issue of Pharmafocus in 2025! In the UK, we are preparing for our final month of winter before moving into spring, and as winter comes to a close, the time for new beginnings comes into view. With insights into how artificial intelligence (AI) is changing processes in the pharmaceutical industry, we must ask: is this the beginning of a total AI-led revolution?

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The University of Sheffield, UK, has announced study results for its trial into the survival rates of patients with operable bladder cancer, finding that those who have immunotherapy before and after the surgery have significantly improved rates of survival.

The European Commission (EC) has announced the opening of a new Biotech and Biomanufacturing Hub, supporting start-ups and small-to medium-sized enterprises (SMEs) in bringing new innovations to the EU market.

US-based pharmaceutical company Alvogen has issued a voluntary recall of one batch of its Fentanyl Transdermal System 25mcg/h transdermal patches, amid concerns that patches could be multi-stacked in a single product pouch.

HUTCHMED has announced that the China National Medical Products Administration (NMPA) have granted a priority review for a new drug application (NDA).

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Aplagon, a clinical stage biopharmaceutical company dedicated to the development of first-in-class therapeutics for thrombo-inflammatory diseases, has announced the closing of a €7m financing round for the initiation of phase 2a of its clinical trials.

Swedish biopharmaceutical company AnaCardio has announced the completion of a Series A extension financing round that has raised $19m for its novel contractile agents. The round was co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures.

Novadip Biosciences, a clinical stage biotechnology company with a specialty in regenerative medicine, has announced the results of its 12-month post-surgical visit as part of phase 1b/2a of the NCT05693558 trial.

Beckley Psytech Ltd, a clinical-stage biopharmaceutical company that specialises in the production of accessible medicines for mental health conditions, has announced positive results for the phase 2a study into BPL-003 in patients with moderate-to-severe alcohol use disorder (AUD).

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to ANDEMBRY (garadacimab) by CSL for the prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients over the age of 12.

Johnson & Johnson company Janssen-Cilag Interenational NV has announced news that the European Commission (EC) has approved a marketing authorisation for the combination of LASCLUZE (lazertinib) and RYBREVANT (amivantamab) for first-in-line treatment of adult patients with epidermal growth factor receptor (EGFR) mutations exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations in non-small cell lung cancer (NSCLC).

The Medicine and Healthcare products Regulatory Agency (MHRA) has approved quadruplet therapy, Sanofi’s SARCLISA (isatuximab) in combination to treat multiple myeloma in patients who are ineligible for a transplant.

Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence (NICE) for AGAMREE (vamorolone) to be used as treatment of Duchenne Muscular Dystophy (DMD) in patients who are aged 4 or older in the UK.

The launch of new RNA company Inverna Therapeutics was announced earlier this month. Inverna Therapeutics begins with a programme aimed at transforming patient outcomes for those with Huntingdon’s disease. Huntingdon’s disease is hereditary, and the condition stops parts of the brain from working over a length of time.

The GSK-Oxford Cancer Immuno-Prevention Programme was announced at the end of January and will focus on researching the prevention of cancer through vaccination. The programme is an additional development to the existing relationship between Oxford University and GSK, including the GSK-Oxford Institute of Molecular and Computational Medicine in Oxford, UK.

Takeda,aglobal biopharmaceutical company, is due to launch a project, INTERCEPT, which will use biomarkers to prevent symptomatic onset of Crohns Disease before the disease begins to affect patients, later in February. The trial is a first in Europe.

Upperton Pharma Solutions, a contract and development manufacturing organisation (CDMO) based in the north of England, UK, has announced the expansion of its 50,000ft22 site Trent Gateway with the newly-completed £7m sterile manufacturing facility.

Subsidiary of Molex, Phillips Medisize, has announced the successful acquisition of Vectura Group Ltd. The acquisition was completed through an affiliate.

CANDOR Biosciences, a supplier in immunoassay solutions, has been acquired by Medix Biochemica, a supplier of raw materials for in vitro diagnostics (IVD). This will support the vision from Medix Biochemica to become the first-in-choice partner for raw materials in the IVD industry.

A division of European specialty generics platform Stragen Group, Stragen Services, has been acquired by ProductLife Group (PLG), a global consulting services specialising in areas around scientific, regulatory, compliance and digital transformation.

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Vikas Jain at Tata Consultancy Services examines three key avenues for AI to be adopted by the pharma industry and the benefits that each adoption can have.

Rob Brown at Sapio Sciences explores how technologies like natural language processing, generative artificial intelligence and AI agents are revolutionising drug discovery, transforming lab informatics tools like electronic lab notebooks and laboratory information management systems into virtual lab assistants

John Stone at Steritas analyses the benefits that a quantifiable index system can have for researchers looking into steroid toxicity.

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Ruthie Davi and Elizabeth Lamont at Medidata AI discuss how adopting different approaches, such as synthetic control arms and remote monitoring, can aid researchers in investigating rare diseases.

David Loose has been appointed as chief executive officer of Essex Management, part of contract research organisation Emmes Group.

The International Drug Development Institute (IDDI) has announced changes to its executive leadership team to strengthen the company’s leadership and operational capabilities.

PrecisionLife has appointed seasoned executive Bill Keating as chief commercial officer of Diagnostics and Healthcare to drive commercial strategy for precision medicine.

Vect-Horus, a private biotechnology company specialising in molecular development, has announced the appointment of Jérôme Berger to its board of directors.

Novel obesity treatment-focused biopharmaceutical company Antag Therapeutics has announced the appointment of Joerg Moeller MD PhD as chief executive officer.

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According to statistics from the Office for Life Sciences, interventional clinical trials in 2023-2024 featured 19,984 participants – a 9.2% reduction compared to the same time frame in 2022-2023.

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