First global patient recruited for rare blood cancer study at King’s
The UK’s King's College Hospital NHS Foundation Trust has announced the first global patient recruitment for TAK-226-3001, a Takeda Pharmaceuticals’ …
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Novartis’ $12bn Avidity bet falters on late-stage del-desiran flop
Novartis’ Avidity Biosciences-acquired therapy, delpacibart etedesiran (del-desiran), has stumbled in a Phase III muscle wasting disorder study, dealing another blow …
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Novo’s Wegovy touts obesity-treating potential in patients as young as six
Novo Nordisk’s blockbuster weight loss drug, Wegovy (semaglutide), has met its primary endpoint in a Phase III post-marketing study in …
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Rezubio doses first cohort in Phase I trial of inhaled RZ-520
Rezubio has dosed the first cohort of patients in a Phase I trial of RZ-520, an inhaled therapeutic drug for …
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Develop site-centric protocols to optimize enrollment and maximize performance
In an attempt to meet regulatory expectations, clinical trials are challenged by highly complex protocol design. But these study plans …
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Remedying the paper trail: Manufacturing a digital route to compliance
Regulatory investigators’ remit extends beyond routine standard operating procedure (SOP) reviews; they watch how operators work, how equipment is qualified, …
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Novo Nordisk’s ziltivekimab stumbles again on pair of Phase III terminations
Novo Nordisk has opted to prematurely end two Phase III trials of its inflammation-targeting candidate, ziltivekimab, after the drug was …
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Clover’s respiratory combo vaccines secure Phase II wins in elderly recipients
Clover Biopharmaceuticals’ combination vaccines for respiratory diseases have posted positive data during a Phase II trial in older recipients – …
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Acepodia secures FDA clearance to begin Phase I ACE723 trial
Acepodia has secured the US Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application for ACE723, …
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Novartis’ pelacarsen fails to meet primary endpoint in Lp(a)HORIZON trial
Novartis has reported that the Phase III Lp(a)HORIZON trial of pelacarsen failed to meet its primary endpoint in patients with …
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A practical framework for choosing e-signatures in global trials
Ask a clinical trial sponsor when to use a qualified e-signature (QES) instead of a standard e-signature (AES), and you'll …
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Argo points to swelling disorder drug’s differentiated profile on Phase II success
Argo Biopharmaceutical has debuted new data from a Phase II study on its preventative therapy, BW-20805 in hereditary angioedema (HAE), …
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MRSA therapeutics market to reach $1.8bn across 7MM in 2034
The methicillin-resistant Staphylococcus aureus (MRSA) therapeutics market across the seven major pharmaceutical markets (7MM), comprising the US, 5EU (France, Germany, …
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Climb Bio reports Phase I results for CLYM116 in IgA nephropathy
Climb Bio has reported positive initial findings from its ongoing Phase I trial of CLYM116, an anti-A Proliferation-Inducing Ligand (APRIL) …
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Akeso and Summit’s ivonescimab meets OS goals in NSCLC
Akeso and Summit Therapeutics’ ivonescimab has shown further benefit in a first-line non-small cell lung cancer (NSCLC) Phase III study, …
