Pharvaris charts approval course for swelling disorder drug on Phase III win
Swiss biopharma company Pharvaris will file for US approval of deucrictibant XR in the rare swelling disorder hereditary angioedema (HAE), …
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Orphalan launches Phase III TRADITiONAL trial for Wilson disease
Orphalan has launched the TRADITiONAL Study, a global Phase III clinical trial of an investigational once-daily formulation of trientine tetrahydrochloride …
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Imfinzi-Imdelltra combo builds frontline SCLC case on Phase III win
A combination of AstraZeneca’s Imfinzi (durvalumab) and Amgen’s Imdelltra (tarlatamab) have been shown to significantly boost patient outcomes versus Imfinzi …
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BMS reports positive data from Phase II QUINTESSENTIAL study for r/r MM
Bristol Myers Squibb (BMS) has reported positive top-line results from the registrational Phase II QUINTESSENTIAL trial of arlocabtagene autoleucel (arlo-cel; …
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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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Osaka has the science. Now it needs the business
Osaka has the science. Now it needs to build the companies, capital and global reach to turn that science into …
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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 …
