Regulatory Filings and Submissions

Pfizer and BioNTech to Supply Japan and Canada with mRNA-Based COVID-19 Vaccine Candidate

August 07, 2020

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

J&J in $1-Billion Agreement with US Government for 100 Million Doses of Investigational COVID-19 Vaccine

August 07, 2020

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

Sanofi and GSK to Supply COVID-19 Vaccine to US Government and European Union

August 07, 2020

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

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.

Formulating an ADC Development Solution

August 02, 2020

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

EC Grants Marketing Authorization for Remsima

July 29, 2020

Celltrion Healthcare has announced that the EC has granted marketing authorization for its subcutaneous formulation of Remsima (infliximab, CT-P13).

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?

FDA Maps Expectations for COVID Vaccine Proposals

July 09, 2020

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

FDA Grants Orphan Drug Designation to Prestige BioPharma’s Anti-Cancer mAb

July 01, 2020

While there currently is no molecular therapy targeted against the PAUFgene, Prestige believes its monoclonal antibody has the potential to benefit patients affected by PAUF-positive pancreatic cancer.