thought leadership

SEPTEMBER 29, 2023

Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs (including small molecules, vaccines, cell and gene therapy products, biologics, etc.), Generic Drugs, Biosimilars, and Medical Devices.

FDA 45

FDA Small Molecule Biosimilars Government 45

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

FDA Law Blog: Biosimilars

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Government 102

Government Small Molecule FDA Approval Regulations 102

The Pharma Data

MARCH 13, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

Pharmaceuticals 52

Pharmaceuticals Small Molecule Biosimilars Disease 52

The Pharma Data

MARCH 29, 2022

With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars.

Trials 52

Trials Small Molecule Biosimilars Disease 52

Agency IQ

OCTOBER 6, 2023

FDA’s approval volume seems to have recovered from a dip in FY 2022, driven mostly by biologics Now that the government’s – and the FDA’s – fiscal year has come to a close, AgencyIQ has reviewed all novel drug approvals for FY 2023. government fiscal year runs from October 1 – September 30. As a reminder, the U.S.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

AUGUST 3, 2021

announced an exclusive collaboration focused on the discovery, development and commercialization of potential novel small molecules that stimulate tumor-specific immune responses. and international governments and near-term expiry dates of COVID-19 antibodies. Loxo Oncology at Lilly and Kumquat Biosciences Inc.

Production 52

Production Marketing Research Government 52