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Discovery & Development Clinical Trials

How Pandemic-Era Ingenuity Fuels the Future of Clinical Trials

| Allison Cuff Shimooka | 7 min read

During the COVID-19 pandemic, significant progress was made in improving clinical trials. But there are now signs of backsliding.


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 Vaccines

The Front Lines of Tuberculosis Vaccine Research

| Stephanie Vine | 10 min read

There has been no new TB vaccine for over 100 years, but a candidate in phase III has just finished enrolling the target of 20,000 participants.

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.”

Manufacture Bioprocessing - Upstream & Downstream

Advances and Opportunities in Biologics Formulation

| Heonchang Lim, Derrick Katayama | 2 min read

The challenges of developing optimized biologics formulations are well known, but the good news is that the industry continues to develop solutions.

Discovery & Development Formulation

Can AI Help Solve the Solubility Challenge?

| 10 min read

We explore how AI-based tools are making a mark in formulation by improving solubility.

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.

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May Issue of The Medicine Maker