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Clinical Trials & Development1 month agoCDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs)
CDER's primary focus is ensuring the safety and efficacy of human drugs. It has become increasingly clear that new approach methodologies (NAMs)—when combined with knowledge of...
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Clinical Trials & Development1 month agoDPHARM: Where to begin with AI in clinical trials?
The promise of AI to transform the clinical trial process is being realized in fits and starts, but early applications of the technology might be surprising.
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Clinical Trials & Development1 month ago
Inside the growing world of biopharma prediction markets
In this episode of “The Top Line,” we explore the growing space of biopharma prediction markets, how they work and the risks they create around insider...
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Clinical Trials & Development1 month ago
Xenon pauses phase 3 depression trials after psychosis events
The company has voluntarily stopped enrolling new patients in the studies in response to reports of mostly mild or moderate adverse events.
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Clinical Trials & Development1 month ago
BMS dumps $100M Orum degrader-antibody conjugate after glimpsing phase 1 data
Bristol Myers Squibb has axed the degrader-antibody conjugate it bought from Orum Therapeutics for $100 million, walking away from the asset after seeing phase 1 data.
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Clinical Trials & Development1 month ago
Novo’s Denecimig Demonstrates Tolerability After Switch from Emicizumab in FRONTIER5 Study of People with Haemophilia A as Published in the Journal of Thrombosis and Haemostasis
Bagsværd, Denmark and Plainsboro, NJ, US, 17 September 2026 – Novo Nordisk today announced that phase 3b results from the FRONTIER5 study of investigational denecimig were...
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Clinical Trials & Development1 month agoDrug Safety Oversight Board (DSB) Meeting June 26, 2024
Public Summary for June 26, 2024 Drug Safety Oversight (DSB) Meeting. This includes a summary and links to the 5 Drug Safety Communications (DSCs) that posted...
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Clinical Trials & Development1 month agoHuman Drug Compounding
Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.
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Clinical Trials & Development1 month agoSTAT+: A Sellas immunotherapy study, long delayed, will end in failure
Why Sellas' experimental immunotherapy study is a blowup waiting to happen.
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Clinical Trials & Development1 month ago
Roche’s Lunsumio delivers positive confirmatory trial readout in follicular lymphoma
Roche’s T-cell engager portfolio has notched another milestone, as a phase 3 trial of the company’s Lunsumio met its primary endpoint in earlier-line follicular lymphoma.
Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
Genmab’s cancer bispecific delivers early OS win in ‘exceedingly positive’ Phase 3 readout
STAT+: HHS moves to allow compounding of some unapproved peptides
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
