Merck & Co’s efforts to diversify its cancer pipeline beyond immunotherapy blockbuster Keytruda have taken a big step forward with a wide-ranging alliance with China’s Kelun-Biotech that spans seven antibody-drug conjugates (ADCs) in early development. Merck is paying a relatively…
Japanese drugmakers make greener packaging pledge
Four Japanese drugmakers – Astellas, Eisai, Daiichi Sankyo, and Takeda – have joined forces in a partnership intended to reduce the environmental impact of pharmaceutical packaging. The companies say they will promote the use of greener packaging for their products…
BioNTech begins Phase I study of vaccine candidate for Malaria
BioNTech has commenced a first-in-human Phase I study of the first candidate from its malaria vaccine programme BNT165, BNT165b1. The company aims to develop the first mRNA-based vaccine to prevent Malaria using a new multi-antigen vaccine method. Initially, it will…
Year in review: who were the main DCT players in 2022?
As we count down to the end of 2022, we look at the sponsors, CROs, and sites that were at the top of the decentralised clinical trial (DCT) race. We also explore the countries where DCTs were frequently conducted. Clinical…
Kira gets clearance for bifunctional biologic trial in China, Australia
The trials will assess the safety, efficacy, tolerability, PK and PD of KP104 in IgAN and C3G patients. KIRA Pharmaceuticals has received clearances in China and Australia to commence Phase II clinical trials of investigational bifunctional biologic, KP104, for IgA nephropathy (IgAN)…
EU regulators publish new recommendations on decentralised trials
The recommendations are made to protect the rights and well-being of patients who participate in clinical trials. The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published new recommendations aiming to…
FDA approves first gene therapy for high-risk early bladder cancer
The first gene therapy for high-risk non-muscle-invasive bladder cancer has been approved by The US Food and Drug Administration (FDA). The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder…
Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from…
Investigation launched into alleged animal welfare violations at Neuralink
Elon Musk’s brain computer interface (BCI) company Neuralink is being investigated by law enforcement authorities in the US amid allegations of animal welfare violations in its testing facilities. Neuralink’s BCI is intended to treat conditions like blindness and spinal cord…
NHS Health Check to be digitised to ease GP pressure
A digital version of the NHS Health Check for 40- to 74-year-olds is to be piloted by the government as a way to lessen pressure on the nation’s GP services. The NHS Health Check is designed to identify early signs…
