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news.Teva receives FDA approval for Prolia biosimilar
The FDA approval of Ponlimsi is based on a comprehensive evidence package, including analytical and clinical data showing immunogenicity, safety, and similar efficacy to Prolia. Ponlimsi is approved
The FDA approval of Ponlimsi is based on a comprehensive evidence package, including analytical and clinical data showing immunogenicity, safety, and similar efficacy to Prolia. Ponlimsi is approved
The partnership focuses on progressing Cellinfinity BIO’s programmes CIB-301 and CIB-350. uBriGene’s LVV Turbo platform will provide good manufacturing practice (GMP) lentiviral vector manufacturing, production, process development, and
The deal is anticipated to close in the second quarter of 2026, subject to standard conditions. The acquisition aims to expand Otsuka’s portfolio in the psychiatric and neurological
It is indicated as an adjunct to exercise and diet for improving glycaemic control. The FDA’s decision is based on data from the ONWARDS Phase IIIa clinical programme,
The acquisition will provide access to Exl-111, a half-life extended, high-affinity anti-IgE antibody currently in Phase I clinical trials. Designed as an advanced extension of the established biology
The partnerships aim to apply AI within scientifically validated modelling workflows and define scalable, next-generation approaches throughout the drug development life cycle. The programmes will use Simulations Plus
The initiative will combine Cognito Therapeutics’ investigational Spectris technology platform with the clinical infrastructure of Ochsner Health to explore innovative approaches to brain health across urban and rural
Daiichi Sankyo will utilise Tempus’ foundation models such as PRISM2, which integrates pathology images and clinical data to generate diagnostic and predictive insights. The partnership will combine Daiichi
Cardiac amyloidosis is a progressive condition where misfolded proteins accumulate in the heart muscle, often leading to heart failure. There are two main types of cardiac amyloidosis: wild-type
Under the agreement, Quotient will receive $20m upfront and could also earn up to $2.2bn through regulatory, development, and commercial milestone payments. Quotient’s somatic genomics approach analyses naturally