Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

Therapies 72

Therapies Clinical Supply Clinical Trials Trials 72

The Pharma Data

AUGUST 15, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.

Disease 52

Disease FDA Treatment Clinical Trials 52

Alta Sciences

DECEMBER 14, 2023

. - Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Image GettyImages-897885148_pharmacy.jpg Tags Clinical Trials

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

The Pharma Data

JANUARY 10, 2021

For more information, please contact: SOURCE: MorphoSys AG via EQS Newswire. View source version on accesswire.com: [link]. Source link.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

The Premier Consulting Blog

OCTOBER 26, 2022

During the development cycle of a regulated therapeutic, the transfer of the manufacturing process is inevitable. Most of the available information at this point has been developed at the bench and pilot scale, and good manufacturing practice (GMP) is not introduced until the production of early clinical supplies.

Production 40

Production Assay Development Clinical Supply Clinical Development 40

The Pharma Data

JANUARY 24, 2021

In clinical research, Cepharanthine exhibits multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic properties. Sairiyo is currently focused on advancing the clinical development of Cepharanthine to treat rare cancer diseases.

FDA 52

FDA Drugs Clinical Development Disease 52