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Business & Regulation Standards & Regulation

FDA Plans for Shorter Drug Reviews

| Kerri Miller | 2 min read

Martin A. Makary and Vinay Prasad write that “rapid or instant reviews” could be possible at the FDA.


Manufacture Advanced Medicine

This Week’s CGT News: Sarepta Gets FDA Platform Technology Designation

| 4 min read

Our latest news roundup reports on dysfunction observed in edited blood stem cells, and RFK Jr’s support for experimental treatments.


Manufacture Advanced Medicine

Using Machine Learning to Improve Gene Therapy Design

| Stephanie Vine | 2 min read

Stanford University researchers explore how zinc fingers can enhance gene therapy.

Business & Regulation Standards & Regulation

RFK Jr Fires CDC Vaccine Advisory Committee

| Stephanie Vine | 3 min read

All 17 members removed from advisory panel, with RFJ Jr claiming it is “plagued with conflict of interest.”

Discovery & Development Small Molecules

Navigating the Therapeutic Landscape of GERD

| Rob Coker | 2 min read

A glimpse into the research of one of the most prevalent gastrointestinal disorders worldwide, and how small molecule drug development is helping.

Business & Regulation Business Practice

This Week’s Biopharma News: Argentina’s WHO Exit and Sanofi Acquisition of Blueprint Medicines

| Rob Coker | 4 min read

Our latest news roundup reports on Novartis’ prostate cancer trial, Sandoz’ osteoporosis biosimilars, and more.

Business & Regulation Advanced Medicine

Preparing National Strategies for CAR T: The Latest IQVIA Report

| Rob Coker | 5 min read

The IQVIA Institute’s latest report evaluates how well seven countries are prepared to support the complex infrastructure required for CAR T therapies

Manufacture Advanced Medicine

This Week’s CGT News: Smart Cell Therapy Facility for Japan

| 5 min read

Our latest news roundup reports on a cell therapy facility expansion in Princeton, a magnet to capture T cells, and more.

Manufacture Advanced Medicine

Gene Therapies for Newborns

| Stephanie Vine | 2 min read

Work from the lab of Luigi Naldini identifies postnatal window for in vivo gene editing, without the need for conditioning or transplantation

Discovery & Development Dosage Forms

Psoriasis: More Than Skin Deep

| Rob Coker | 4 min read

Recent developments in the treatment of psoriasis has brought new hope to sufferers, and a surge in market standings.

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May Issue of The Medicine Maker