The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to a treatment for osteosarcoma. SOT106, developed by biopharmaceutical company SOTIO Biotech, is a next-generation antibody-drug conjugate (ADC) targeting leucine-rich repeat-containing 15 (LRRC15), a clinically validated target broadly expressed across sarcoma subtypes and in tumour associated stroma. Preclinical data… Read More
Herantis is set to advance the clinical development of its Alzheimer’s therapy following a positive meeting with the US Food and Drug Administration (FDA). The company reports it completed a pre-IND meeting with the FDA to discuss the planned clinical development of HER-096, a first-in-class small peptide being developed to… Read More
The National Institute for Health and Care Excellence (NICE) has recommended Nucala (mepolizumab) as an add-on treatment for NHS patients with COPD. The draft final guidance recommends mepolizumab as an add-on maintenance treatment option for adult patients with uncontrolled COPD with raised blood eosinophils, if they are having… Read More
Introduction In an age where novel biotechnology products are being developed on a much larger and more rapid scale at significantly higher costs and risks than ever before, it is important that this urgency is maintained through to patient access. Owing to the broad reach and the mass… Read More
The National Institute for Health and Care Excellence (NICE) has recommended cemiplimab in combination with platinum-based chemotherapy to treat patients with non-small cell lung cancer (NSCLC). Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, which was shown to block cancer cells from… Read More
Patients in Europe are waiting longer to access medicines than patients in the US, a new report warns. The European Federation of Pharmaceutical Industries and Associations (EFPIA)’s report shows 49% of FDA-approved medicines are not available in Europe, up from 46% in 2019. Data also… Read More
Cyclana Bio has been granted Health Research Authority (HRA) and Research Ethics Committee (REC) approval by the NHS to launch a study into endometriosis. The biotechnology company will now go ahead with its 500-patient clinical observational study, being called PEMP (Predicting Endometriosis Mechanisms and Populations), to improve understanding… Read More
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Baxfendy (baxdrostat) in the US for the treatment of hypertension. Baxfendy has been approved as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not… Read More
On International Clinical Trials Day, industry experts speak to DDW about the current state of play within global clinical trials. DDW: How encouraged are you by regulatory reforms… Read More
The US Food and Drug Administration (FDA) has given an advanced manufacturing technology (AMT) designation to Cytiva’s transient cell line, making it one of the first gene therapy manufacturing technologies to receive the designation. The ELEVECTA transient cell line for adeno-associated virus (AAV) manufacturing is said to reduce the formation… Read More
The Medicines and Healthcare products Regulatory Agency (MHRA) is opening a new hub in Northern Ireland to boost life sciences growth in the country. The hub, hosted by Invest Northern Ireland, aims to build on MHRA’s partnerships in healthcare, academia and industry in… Read More
The US Food and Drug Administration (FDA) has approved the first treatments for all serotypes of patients living with generalised myasthenia gravis (gMG). The FDA’s label expansion of Vyvgart (efgartigimod alfa-fcab) and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) now means gMG adult patients can treat all serotypes, including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive,… Read More
Brian Malkin and Sadaf Deedar, Spencer Fane LLP, unpack the recent changes to the FDA’s Priority Review Voucher scheme and the upcoming review of its effectiveness in promoting drug development for rare paediatric diseases. Congress recently enacted the Consolidated Appropriations Act, 2026 (CAA)… Read More
The US Food and Drug Administration (FDA) has granted Fast Tack Designation for an immune medicine targeting triple-negative breast cancer. RPTR-1-201 is a novel T cell receptor (TCR) bispecific immune medicine, developed by biotechnology company Repertoire Immune Medicines, that is currently in a Phase I/II trial for the… Read More
The US Food and Drug Administration (FDA) has granted Fast Track Designation to a treatment for amyotrophic lateral sclerosis (ALS). Tazbentetol, developed by biopharmaceutical company Spinogenix, is a once-a-day pill with potential to restore synapses, the key connections between neurons that allow people to think, plan, remember… Read More
The US Food and Drug Administration has announced two major steps as part of an initiative to advance the implementation of real-time clinical trials (RTCT). First, the agency unveiled the successful initiation of two proof-of-concept clinical trials that will report endpoints and data signals to the agency… Read More
