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FDA in Hot Seat on Buy American Drug Policy

August 10, 2020

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

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.

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.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology

August 07, 2020

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

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.

Lonza Expands its Microbial Manufacturing Facility in Switzerland

August 06, 2020

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

Catalent to Expand its Argentinian Site

August 06, 2020

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

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.

Drug Safety Summit Discusses Impact of COVID-19 on Pharma Supply Chain

August 05, 2020

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.