The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease.

Disease 52

Disease FDA Treatment Clinical Trials 52

The Pharma Data

DECEMBER 14, 2020

Over the last two years, AlgoTherapeutix took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production.

Clinical Development 52

Clinical Development Clinical Supply Pharmacokinetics Clinical Trials 52

Drug Target Review

SEPTEMBER 10, 2024

In our experience, reaching a rapid drug substance material delivery to support toxicology studies is becoming a major milestone on the Phase I CMC clinical development path (Figure 1). Therefore, there would be almost no appetite for trying to justify a change in formulation between Tox and clinical supplies.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

Alta Sciences

DECEMBER 14, 2023

. - Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Clinical Supply Manufacturing Integration with our manufacturing team, ensuring flexibility and adaptability to meet the evolving needs of your studies throughout your drug development program or study.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

The Pharma Data

JANUARY 10, 2021

Food and Drug Administration (FDA) granted accelerated approval of the company’s proprietary product Monjuvi (R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

LifeSciVC

AUGUST 21, 2024

Keeping ahead of schedule will help to maintain manufacturing efficiencies, ensure adequate supply and product quality, and meet development timelines. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us.

Clinical Trials 70

Clinical Trials Trials Disease Treatment 70

The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases.

FDA 52

FDA Drugs Clinical Development Disease 52