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Drug Discovery & Development
nPhase.AI becomes the industry’s first AI-native enterprise platform for end-to-end clinical data management
nPhase, a clinical research technology company, has launched nPhase.ai, the life sciences industry’s first enterprise platform for end-to-end clinical data management.
The company also introduces nPhase.ai SCE (Statistical Computing...
Clinical Trials Insights
ENA Respiratory begins part B dosing in INNA-051 phase 2a community study designed to protect against symptomatic viral respiratory infections
ENA Respiratory, a clinical-stage pharmaceutical company developing host defence enhancers for the prevention of complications associated with respiratory viral infections in at-risk populations, has dosed the first...
Technology and Automation
Brainomix and Endeavor present positive results from quantitative image analysis of phase2a idiopathic pulmonary fibrosis (IPF) trial
Brainomix, a leading medtech company specialising in AI-powered imaging tools for lung disease and stroke; and Endeavor BioMedicines, a clinical-stage biotechnology company, presented positive...
Yourgene Health, an international molecular diagnostics company with a broad portfolio of integrated technologies and services, has announced the commercial launch of its In Vitro Diagnostic...
Clinical Trials Insights
Just – Evotec Biologics advances US Department of War antibodies against orthopoxvirus into phase 1 clinical studies
Evotec SE has announced the initiation of a phase 1 clinical trial evaluating JST-018, a cocktail of investigational monoclonal antibodies targeting orthopoxviruses, developed by...
Finance, mergers and appointments
Vertex Completes acquisition of Crinetics Pharmaceuticals and announces expansion of executive leadership team
Vertex Pharmaceuticals has successfully acquired Crinetics Pharmaceuticals, a global pharmaceutical company focused on the discovery, development and commercialisation of novel therapeutics for endocrine diseases. Vertex also...
Drug Discovery & Development
Takeda Receives US FDA approval of Mimrylo (rusfertide), marking a potential shift in the treatment paradigm for polycythaemia vera
Takeda has announced US FDA approval of the New Drug Application (NDA) for Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythaemia...
Drug Discovery & Development
uniQure announces submission of biologics license application for ifezuntirgene inilparvovec (AMT-130) in Huntington’s Disease
UniQure has applied for a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the accelerated approval of ifezuntirgene inilparvovec (AMT-130), an...
Clinical Trials Insights
Novartis remibrutinib significantly reduces relapse rates and shows favourable safety profile in phase 3 RMS trials
Novartis has announced positive topline results from its phase 3 trials of remibrutinib in relapsing multiple sclerosis.
Remibrutinib, a highly selective and potent oral Bruton’s...
Drug Discovery & Development
FDA approves Imaavy (nipocalimab-aahu) as first-ever treatment for warm autoimmune haemolytic anaemia (wAIHA), representing a landmark advancement for patients
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA) – a...
Clinical Trials Insights
GSK to advance mRNA seasonal flu vaccine candidate to phase 3 following positive phase 2 data
GSK presented positive phase 2 data for its mRNA seasonal influenza (flu) vaccine candidate at the Options XIII Conference for the Control of Influenza.
GSK’s...
Drug Discovery & Development
FDA approves Gilead’s Bixlenvo, a new once-daily single tablet option for virologically suppressed adults with HIV, including those on complex regimens
The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Bixlenvo (bictegravir 75 mg/lenacapavir 50 mg), the smallest once-daily single tablet regimen (STR) for...
Finance, mergers and appointments
Lilly to acquire Merida Biosciences to advance treatments for serious autoimmune and allergic diseases
Eli Lilly and Merida Biosciences, have announced a definitive agreement for Lilly to acquire Merida.
Merida is developing biologics engineered to selectively degrade pathogenic autoantibodies, the disease-causing agents behind a...
Clinical Trials Insights
New phase 3b data on Eli Lilly’s Taltz (ixekizumab) and Zepbound (tirzepatide) used together showed improved and durable efficacy at one year in adults...
Eli Lilly and Company (NYSE: LLY) has announced 52-week results from Together-PsO and Together-PsA, two novel open-label phase 3b clinical trials evaluating the concomitant use of...
Clinical Trials Insights
Acoramidis demonstrates reversal of cardiac structural disease progression and functional decline and significantly increases days alive and free from hospitalisation in ATTR-CM
BridgeBio Pharma has presented new analyses from the phase 3 study of Attruby (acoramidis) in transthyretin amyloid cardiomyopathy (ATTR-CM), including the cardiac magnetic resonance...
Drug Discovery & Development
European Commission approves Jascayd, bringing well-tolerated, novel oral treatment for IPF and PPF to the EU
The European Commission (EC) has granted marketing authorisation for Boehringer Ingelheim’s Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) and...
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