May
22
2018

Gene Therapies That Could Transform Diseases Get Easier FDA Path

Bloomberg

New therapies that may cure diseases caused by defective genes will get a faster path to approval by U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.

May
22
2018

FDA Chief Gottlieb Is Building a Regulatory Speedway to Accelerate Gene Therapy Development

Endpoints News

In a rallying cry for gene therapy, FDA Commissioner Scott Gottlieb says he’s determined to clear the pathway for drug developers in a move to accelerate the first wave of gene therapies pointed to the market.

May
22
2018

Help Coming on Gene Therapy Development

Politico Pro - Subscription Only

The FDA will soon release a series of guidance documents that it hopes will speed development of the already rapidly growing world of gene therapies, according to Commissioner Scott Gottlieb.

May
22
2018

Politico Influence

Politico

Members of the Alliance for Regenerative Medicine are in town, too, talking with lawmakers about gene therapy, cell therapy and tissue engineering. They’re meeting with dozens of congressional offices.

May
07
2018

25 Up and Coming Gene Therapies

Genetic Engineering & Biotechnology News

This article discusses 25 gene-therapy candidates that have reached Phase III and/or registrational trials as of Q1 2018.

Mar
20
2018

Cell Therapy Manufacturing – Opportunities and Challenges

The Cell Culture Dish

In this podcast and accompanying we interviewed Dr. Robert Preti about the past, present and future of global cell therapy manufacturing.

Mar
19
2018

Europe’s Pharma Companies Join with Non-Profit Group in Push to Measure Outcomes of Medical Treatments

Science Business

An alliance with outcomes measurement body ICHOM intends to accelerate the push towards value-based care. The aim is to square the circle between the budget squeeze facing healthcare systems and paying for medical innovation coming through the pipeline.