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This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more
This Week at FDA: Pallone pushes for greater ClinicalTrials.gov enforcement, FDA rejects Eli Lilly Alzheimer’s drug, and more
RAPS.org
FDA
regulatory
clinical trials
clinicaltrials.gov
Eli Lilly
donanemab
Medtronic
BeiGene
Seagen
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Eyeing untapped niche, EpicentRx makes case for cancer toxicity prevention drug
Eyeing untapped niche, EpicentRx makes case for cancer toxicity prevention drug
Fierce Biotech
EpicentRx
clinical trials
head and neck cancer
oral mucositis
RRx-001
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Innovative Trial Design may have Cost Lilly’s Donanemab Accelerated Approval
Innovative Trial Design may have Cost Lilly’s Donanemab Accelerated Approval
BioSpace
Eli Lilly
donanemab
FDA
clinical trials
Alzheimer's disease
clinical trial design
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The first big test for the son of Enhertu
The first big test for the son of Enhertu
EP Vantage
Daiichi Sankyo
Enhertu
datopotamab deruxtecan
clinical trials
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Gilead Sciences to provide Trodelvy for Strata PATH trial
Gilead Sciences to provide Trodelvy for Strata PATH trial
Clinical Trials Arena
Gilead Sciences
Strata Oncology
Trodelvy
clinical trials
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New clinical trial system to soon become mandatory in Europe
New clinical trial system to soon become mandatory in Europe
Endpoints
clinical trials
Europe
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Irlab's shares plummet 60% after Ipsen-partnered Parkinson's drug flunks phase 2 trial
Irlab's shares plummet 60% after Ipsen-partnered Parkinson's drug flunks phase 2 trial
Fierce Biotech
Ipsen
IRLAB
clinical trials
Parkinson's Disease
mesdopetam
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FDA Clears Application for Phase 2 Clinical Trial of CYR-064 to Treat Post-Viral Smell Loss
FDA Clears Application for Phase 2 Clinical Trial of CYR-064 to Treat Post-Viral Smell Loss
Drugs.com
Cyrano Therapeutics
smell loss
hyposmia
CYR-064
clinical trials
FDA
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Roche’s Tecentriq to be filed for early-stage liver cancer
Roche’s Tecentriq to be filed for early-stage liver cancer
Pharmaphorum
Roche
Tecentriq
Avastin
clinical trials
liver cancer
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Horizon Bags Second Phase II Win in Sjögren’s Syndrome
Horizon Bags Second Phase II Win in Sjögren’s Syndrome
BioSpace
Horizon Therapeutics
Sjögren’s syndrome
clinical trials
dazodalibep
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Phase 2 attrition jumps amid widespread scale-back in overall clinical trial activity: study
Phase 2 attrition jumps amid widespread scale-back in overall clinical trial activity: study
Fierce Biotech
clinical trials
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J&J packs up HIV vaccine after failing phase 3 trial
J&J packs up HIV vaccine after failing phase 3 trial
Fierce Biotech
JNJ
vaccines
HIV
HIV vaccines
clinical trials
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NewAmsterdam's Amgen castoff cuts LDL cholesterol in phase 2, opening new front in race to market
NewAmsterdam's Amgen castoff cuts LDL cholesterol in phase 2, opening new front in race to market
Fierce Biotech
NewAmsterdam Pharma
Amgen
CETP inhibitors
obicetrapib
clinical trials
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Elicio uses struggling Angion as route to Nasdaq ahead of cancer vaccine's phase 2 move
Elicio uses struggling Angion as route to Nasdaq ahead of cancer vaccine's phase 2 move
Fierce Biotech
Elicio Therapeutics
NASDAQ
cancer vaccines
clinical trials
Angion Biomedica
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Abionyx hails success of bid to resurrect failed cholesterol drug—without dishing data to back up claims
Abionyx hails success of bid to resurrect failed cholesterol drug—without dishing data to back up claims
Fierce Biotech
Abionyx
clinical trials
cholesterol
CER-001
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Alzheimer’s disease trials: How does Lilly’s donanemab compare to lecanemab?
Alzheimer’s disease trials: How does Lilly’s donanemab compare to lecanemab?
Clinical Trials Arena
clinical trials
Alzheimer's disease
Eisai
Biogen
Eli Lilly
Leqembi
lecanemab
donanemab
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JPM2023: Breakthroughs await, but so do roadblocks
JPM2023: Breakthroughs await, but so do roadblocks
Pharmaphorum
JPMHC 2023
Inflation Reduction Act
cell therapy
gene therapy
clinical trials
CNS disorders
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Panbela begins Phase II trial of type 1 diabetes therapy trial
Panbela begins Phase II trial of type 1 diabetes therapy trial
Clinical Trials Arena
Panbela Therapeutics
clinical trials
CPP-1X-T
type 1 diabetes
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Oramed’s oral insulin flunks phase 3 diabetes test, sending stock down 70%
Oramed’s oral insulin flunks phase 3 diabetes test, sending stock down 70%
Fierce Biotech
Oramed
diabetes
type 2 diabetes
clinical trials
insulin
oral insulin
ORMD-0801
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Emalex Biosciences reports data from Tourette syndrome therapy trial
Emalex Biosciences reports data from Tourette syndrome therapy trial
Clinical Trials Arena
Emalex Biosciences
clinical trials
Tourette syndrome
ecopipam
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