A drug to treat Parkinson’s disease can be made from waste plastic bottles using a pioneering method, a study shows. The approach harnesses bacteria to transform post-consumer plastic into L-DOPA, a frontline medication for the neurological disorder. It is the first time a natural, biological… Read More
Novo Nordisk has received a Warning Letter from the US Food and Drug Administration (FDA) related to violations of postmarketing adverse drug experience (PADE) regulations. The letter relates to an inspection that took place in early 2025, in which the FDA found serious violations of PADE reporting… Read More
The US Food and Drug Administration (FDA) has ruled that data from Phase I/II studies are insufficient evidence to approve the marketing authorisation for uniQure’s AMT-130, an investigational gene therapy for Huntington’s disease (HD). In response, investors have issued a class action securities lawsuit to recover losses. Read More
The US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE Phase III clinical trial of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). The clinical holds on the INDs for MAGNITUDE and… Read More
Novo Nordisk has seen a significant fall in its stock value following disappointing trial results for its obesity treatment CagriSema, which is a fixed dose combination of cagrilintide 2.4mg and semaglutide 2.4mg. Although CagriSema demonstrated 23% weight loss in the open-label head-to-head Phase III REDEFINE 4 trial,… Read More
Gilead Sciences has entered into a definitive agreement to acquire Arcellx for an equity value of $7.8 billion. Arcellx is a biotechnology company focused on delivering a new class of immunotherapies for patients with cancer and other incurable diseases. The companies have an existing collaboration… Read More
Sanofi’s Board of Directors has decided not to renew the Paul Hudson’s contract as CEO and to replace him with current Merck CEO Belén Garijo. They have announced that Olivier Charmeil, Executive Vice President, General Medicines, will assume the role of Interim Chief Executive Officer during the… Read More
Lyell Immunopharma has begun its PiNACLE – H2H Phase III trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtageneciloleucel (axi-cel). The CAR-T therapies will be assessed in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the second-line… Read More
The US Food and Drug Administration (FDA) has placed a clinical hold on REGENXBIO’s investigational gene therapy, RGX-111, for the treatment of MPS I, following a single case of neoplasm (intraventricular CNS tumour) in a participant treated in its Phase I/II study. The FDA also placed a… Read More
AstraZeneca has agreed a new strategic collaboration agreement with China’s CSPC Pharmaceuticals to develop multiple next-generation therapies for obesity and type 2 diabetes across eight programmes. Under this agreement, the companies will initially progress four programmes, which utilise CSPC’s AI-driven peptide drug discovery platform and its LiquidGel… Read More
The first participants have been dosed in the first-in-human Phase I clinical trial of NRG Therapeutics’ lead candidate NRG5051, which is being developed as a treatment for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND) and Parkinson’s. NRG5051 is a first-in-class, orally bioavailable and CNS-penetrant next-generation inhibitor of the mitochondrial… Read More
The recent UK-US policy developments are reshaping global pharmaceutical investment and launch strategies, according to intelligence platform GlobalData. In December 2025, the UK announced a landmark pharmaceuticals agreement with the US, granting UK-made medicines and medical technologies tariff-free access to the US market for… Read More
Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together have been shown to deliver superior efficacy in first-of-its-kind Phase IIIb trial for adults with active psoriatic arthritis (PsA) and obesity or who are overweight. At 36 weeks, treatment with concomitant Taltz and Zepbound met the primary and all… Read More
The UK is ramping up efforts to become a global first choice for clinical trials, as new figures show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – designed to help companies get studies up and running more quickly. … Read More
NVIDIA has announced a major expansion of NVIDIA BioNeMo, its open development platform for AI-driven biology and drug discovery, at the JP Morgan Healthcare Conference. The platform has expanded to include: New NVIDIA Clara open models, the RNAPro model for RNA structure prediction and the… Read More
The US Food and Drug Administration (FDA) has cleared GenEditBio to initiate Phase I/II CLARITY trial activities for its lead in vivo genome-editing programme GEB-101 for TGFBI corneal dystrophy. The Phase 1/2 CLARITY trial will collect initial data on the safety, tolerability and efficacy of… Read More
