Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. 2 EvaluatePharma, World Preview 2020, Outlook to 2026. AstraZeneca PLC. _.

Regulations 75

Regulations International Disease Small Molecule 75

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

Drug Target Review

MARCH 20, 2025

Regulatory approval and market introduction Anthos Therapeutics is actively pursuing the clinical development of abelacimab. “This study will be the basis of a Biologics License Application (BLA) submission to the FDA for the approval of abelacimab, Bloomfield noted. .

Therapies 52

Therapies Trials Clinical Development FDA 52