FDA grants clearance to Prilenia and Ferrer’s Phase III ALS therapy trial
The US Food and Drug Administration (FDA) has granted clearance to Prilenia Therapeutics and Ferrer to commence a Phase III…
All articles by Gullapalli Prasanna
Gullapalli Prasanna
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Lindus Health and Quotient Sciences to support sponsors with trial recruitment
Lindus Health and Quotient Sciences have entered a strategic collaboration to support biotech and pharmaceutical sponsors with subject recruitment for…
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UK MHRA clears Ensoma’s EN-374 trial application for X-CGD
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared Ensoma’s clinical trial authorisation (CTA) application for its in…
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EpilepsyGTx secures $33m to progress FRE therapy through Phase I/IIa trials
Biotechnology firm EpilepsyGTx has secured $33m in a Series A funding round to progress its adeno-associated viral (AAV) gene therapy,…
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Valneva reports final results from Phase II Lyme disease vaccine trial
Valneva has reported final safety and immunogenicity findings from the randomised Phase II trial, VLA15-221, assessing the Lyme disease vaccine…
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Roche reports positive Phase III data of giredestrant for breast cancer
Roche has reported encouraging outcomes from its Phase III lidERA Breast Cancer trial of oral giredestrant as an adjuvant endocrine…
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WCG unveils Data & Insights Solutions for clinical trials
WCG has introduced Data & Insights Solutions for optimising and expediting clinical study outcomes. The company aims to transform the…
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Neurocrine’s depression treatment misses main goal in Phase II study
Neurocrine Biosciences has reported that its Phase II trial assessing NBI-1070770 in the adult population with major depressive disorder (MDD)…
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EMA approves Arctic Therapeutics’ trial of AT-001 for Alzheimer’s
The European Medicines Agency (EMA) has granted approval to Iceland-based Arctic Therapeutics to commence a Phase IIa trial of small-molecule…
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Roche’s Phase III trial of Gazyva/Gazyvaro for SLE meets primary endpoint
Roche has reported that its Phase III ALLEGORY trial of Gazyva/Gazyvaro (obinutuzumab) in adult patients with systemic lupus erythematosus (SLE)…