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Sourcing Blockbuster Oncology Products for Clinical Trial Supply

XTalks

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

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3BP and Novartis strike licensing agreement for FAP-targeting peptide technology

Pharmaceutical Technology

German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinical trial.

Licensing 130
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Biologic CAR T cell engager approved for UK clinical trial

Drug Discovery World

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

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Clinical trial begins of lung cancer immunotherapeutic

pharmaphorum

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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CMV Vaccine Trials: Moderna’s CMV mRNA Vaccine Enters Phase III

XTalks

The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine. The comparison is particularly important as gB/MF59 demonstrated promise in Phase II clinical trials but did not advance to Phase III.

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Novavax Vaccine Becomes First FDA-Authorized Protein Vaccine for COVID-19

XTalks

The two-dose protein-based, adjuvanted vaccine has been authorized for use in adults 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. In a press release outlining the authorization, the FDA noted that the clinical trial for Novavax’s vaccine was conducted before the appearance of the omicron and delta variants.