Roche seeking earlier use for Lunsumio in FL on Phase III data
Roche is seeking a label expansion to use Lunsumio (mosunetuzumab) at an earlier stage after it showed benefit in a …
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Everest acquires Firma’s biometrics and data services unit
Everest Clinical Research has acquired Firma Clinical Research's biometrics and data services business unit, Firma DS, for an undisclosed sum. The …
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China’s NMPA clears Akeso’s AK158D1 for Phase I trial in solid tumours
Akeso has received clearance from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) to begin …
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Podcast: What’s new in pulmonary fibrosis: Insights from ERS 2026
The 2026 European Respiratory Society (ERS) Conference ended recently after providing a platform for emerging research in pulmonary fibrosis, a …
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Altis Labs’ AI software detected treatment benefit earlier in oncology trial
Altis Labs’ artificial intelligence (AI)-powered imaging endpoint has shown its ability to detect early, notable treatment effects more effectively than …
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Optimi Health plans Phase III trial of PTSD therapy
Optimi Health is set to initiate a Phase III clinical trial to assess methylenedioxymethamphetamine (MDMA)-assisted therapy to treat individuals living …
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SpliSense begins Phase IIb SPL84 trial for cystic fibrosis
SpliSense has commenced a Phase IIb clinical trial of its inhaled antisense oligonucleotide therapy, SPL84, in people with cystic fibrosis …
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Axoltis’ Phase II ALS trial fails; company points to exploratory endpoints
Axoltis Pharma is undertaking additional analysis of its Phase II amyotrophic lateral sclerosis (ALS) trial after it failed to meet …
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OCT China 2026: China becoming ‘centre of gravity’ in global clinical trial sector
China’s rapid growth in recent years has sent ripples across the pharmaceutical sector. The country has experienced significant growth over the …
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Syntis Bio announces Phase I/Ib data for SYNT-101 in obesity
Syntis Bio has reported results from the multiple ascending dose (MAD) segment of its Phase I/Ib SYNTIETY-1 trial of SYNT-101, …
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Arrowhead reports top-line results in mixed hyperlipidaemia trial
Arrowhead Pharmaceuticals has reported interim top-line results from an ongoing Phase I/IIa clinical trial investigating ARO-DIMER-PA to treat mixed hyperlipidaemia. ARO-DIMER-PA …
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Trial run: FDA launches pilot for expedited INDs
The US Food and Drug Administration (FDA) is set to launch its expedited investigational new drug (IND) pilot as it …
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Vera set up for full approval for Trutakna in IgAN with Phase III win
Vera Therapeutics looks well placed for full approval of Trutakna (atacicept-vymj) in primary IgA nephropathy (IgAN) after successful confirmatory data. In …
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Agentic AI trust gap slowing healthcare provider adoption, survey reveals
A new survey from digital healthcare security specialist Imprivata has revealed that, while artificial intelligence (AI) is now becoming commonplace …
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Definium tees up regulatory submission for psychedelic on Phase III hat trick
Definium Therapeutics has drawn up plans to submit a New Drug Application (NDA) to US regulators for its psychedelic medicine, …
