article thumbnail

Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

As demand for these therapies continues to surge, particularly with the emergence of biosimilars, the necessity for strict quality controls during development and manufacturing becomes paramount. To date, more than 160 monoclonal antibody therapies targeting nearly 100 disease-related proteins have received regulatory approval globally.

article thumbnail

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

These are condensed thoughts from his speech Communicating Regulatory Impact to Your Organization: Advanced Procedures for Compliance Success, which he delivered at the 2025 Q1 Productions Life Science Regulatory Intelligence & Strategy Conference.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

Such efforts are intended to improve trust and reliability in basic science and interventions in childhood chronic disease and may have implications for labeling or continued approvals. As described here in brief, FDA has a variety of tools that are already in use to address the issues raised in the MAHA Assessment.

article thumbnail

Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

In an era where science and technology are surpassing what was ever thought possible, the need for the biotech industry to adapt, respond and evolve as quickly and cost efficiently as possible is more urgent than ever. 1 These numbers explain why so many promising biotech firms close their doors each year.

article thumbnail

ACI’s 23rd Advanced Summit on Life Sciences Patents

FDA Law Blog: Biosimilars

Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institutes 23rd Advanced Summit on Life Sciences Patents , which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY.

article thumbnail

Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law Blog: Biosimilars

Given the above, the obvious question seems to be: what will be the role of science in an FDA under Kennedy’s leadership? Science is, at its core, a place to ask questions, to challenge norms, and to make new discoveries, and then to subject those discoveries to replication in a controlled manner.

FDA
article thumbnail

The Commissioner’s Magical Mystery Tour: Many Questions About this Unique Opportunity

FDA Law Blog: Biosimilars

How does he plan on implementing AI in regulatory science and application reviews? How does he plan on implementing the framework for his proposal of a regulatory pathway based on a scientifically plausible mechanism? How does he plan to remedy widely reported low morale among review teams?

FDA