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Cantex secures license to develop small molecule-drug for inflammatory lung diseases

pharmaphorum

Clinical stage pharmaceutical company Cantex Pharmaceuticals has obtained a global licence from Harvard University’s Office of Technology Development to develop the small-molecule drug azeliragon into a treatment for inflammatory lung diseases, including COVID-19. said Cantex CEO Stephen Marcus.

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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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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Worldwide Clinical Trials

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity.

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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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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. for patients with NTRK fusion cancer across all solid tumors.

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Medicinal cannabis: Why more clinical trials and better access is needed

Drug Discovery World

But more robust studies are needed across the board to help with the discovery and development of cannabis-based pharmaceuticals. Big pharma is helping to shape the focus The good news is that clinical trials are on the increase and market education is upping pace.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. BLA process (CBER). 510(k) process (CBER). Premarket Approval (PMA) process (CBER).