BlueRock Therapeutics to start cell therapy trial for Parkinson’s disease
BlueRock Therapeutics is all set to initiate Phase I Study of MSK-DA01 Cell Therapy for advanced Parkinson’s disease (PD) after…
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LoA Update: Amryt’s Juxtapid sees 7-point surge in US approval prospects in familial chylomicronaemia due to positive investigator-led Phase III trial
Amryt Pharma’s Juxtapid (lomitapide) had a 7-point jump in its Likelihood of Approval (LoA) in familial chylomicronaemia syndrome (FCS) on…
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DemeRx and Atai get MHRA nod to start trial of ibogaine for opioid use disorder
A joint venture between DemeRx and Atai Life Sciences has been cleared by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to start enrolment…
Merck withdraws Keytruda from SCLC indication amid FDA crackdown
On 1 March, Merck announced the voluntary withdrawal of its Keytruda (pembrolizumab) immunotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC)…
Algernon seeks ethics approval for Covid-19 trials in Australia
Clinical stage pharmaceutical development firm Algernon Pharmaceuticals is seeking ethics approval in Australia for its planned multinational Phase IIb/III study…
Zhittya gets regulatory approval in Mexico for trial of drug in PD patients
Zhittya Genesis Medicine has secured regulatory approval from Mexico's governing body COFEPRIS to test its drug in people with Parkinson's…
Abeona to initiate Phase III trial of EB-101 to treat RDEB
Abeona Therapeutics is ready to initiate its pivotal Phase III clinical trial, VIITAL, to evaluate EB-101 for the treatment of…
FDA accepts Lilly’s protocol of pain trial for CID initiative
The US Food and Drug Administration (FDA) has accepted Eli Lilly’s pain clinical trial for the Complex Innovative Trial Designs…
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LoA Update: Teva’s extended-release risperidone for schizophrenia sees 5-point boost in regulatory potential following positive Phase III study
The likelihood of approval (LoA) for Teva Pharmaceutical’s TV-46000/mdc-IRM (extended-release subcutaneous risperidone) in schizophrenia rose 5 points as of 23 March,…
LoA Update: Novartis’ Lu-PSMA FDA approval shot in castration-resistant prostate cancer increases 8 points after Phase III efficacy signal
Novartis’ 177Lu-PSMA-617 (Lu-PSMA) for metastatic castration-resistant prostate cancer patients had its likelihood of approval (LoA) rising by 8 points as…
Strategikon Pharma Announces New Software Release of Clinical Maestro
Strategikon Pharma announced a global update for its Clinical Maestro™ platform that advances capabilities for tracking out of scope services…
How to Improve CRO Oversight by Bringing Your TMF In-House
To facilitate virtual TMF inspections and improve efficiency, the European Medicines Agency (EMA) encourages sponsors to provide inspectors direct system…
Why is Translation Software So Important for Clinical Trial Translations?
Translation software is essential for performing high-quality translation, especially in the clinical trial and medical field, as it facilitates and…