Regulatory Authority Actions

Novartis Gets EMA Approval for Two European Commercial CAR-T Manufacturing Sites

August 07, 2020

The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.

FDA Approves First Cell-Based Gene Therapy for MCL

August 06, 2020

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Debate Accelerates Over Who Gets COVID Vaccine First

August 03, 2020

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines and Drugs

August 01, 2020

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

EMA Starts Review of Dexamethasone as COVID-19 Treatment

July 30, 2020

EMA has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

FDA Grants Accelerated Approval to First CAR-T Treatment for Mantle Cell Lymphoma

July 27, 2020

The approval comes after positive results were met in a single-arm, open-label study that resulted in FDA Breakthrough Therapy Designation for the one-time therapy.

Stakeholders Seek Increased User Fee Support for Biologics

July 24, 2020

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

Drug Pricing Back in the Spotlight

July 21, 2020

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

Will FDA Inspections Ever Be the Same?

July 20, 2020

Industry should be seeking more information from FDA on how it will restart its current inspection program.

EMA Issues Final Opinion on Nitrosamines

July 16, 2020

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has issued its final opinion on measures for companies to take that will limit the presence of nitrosamines in human medicines.