The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

DrugBank

SEPTEMBER 26, 2024

For instance, Inflectra , a biosimilar of Remicade, underwent a comprehensive clinical development program, including a Phase III trial demonstrating comparable efficacy and safety to the reference product in patients with rheumatoid arthritis. billion by 2028.

Biosimilars 74

Biosimilars Clinical Trials Production FDA 74

The Pharma Data

NOVEMBER 8, 2020

All Almirall’s production sites continue to operate at full capacity in order to be able to ensure the supply of medicines to all patients requiring treatment. Tirbanibulin is a topical drug for the treatment of actinic keratosis in adult patients developed by Athenex and licensed by Almirall.

Licensing 52

Licensing Licensing Production Treatment 52

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52