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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.

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

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

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

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.

Catalent to Expand its Argentinian Site

The new facility will give the company’s Australian customers access to tablet formulation and coating services in order to shorten supply chains and increase the region’s pharmaceutical sector capacity.

Colorcon Launches New Technical Center in Australia

Ferring Pharmaceuticals US is voluntarily recalling DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL because of superpotency or high amounts of desmopressin.

Nasal Spray Recalled

The companies have entered into an exclusive licensing agreement to develop, manufacture, and commercialize efinopegdutide, an investigational drug for treating nonalcoholic steatohepatitis.

Merck, Hanmi Pharmaceutical Partner in $870-Million Deal to Develop Liver Disease Drug

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.

FDA Approves First Cell-Based Gene Therapy for MCL

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

Lonza Expands its Microbial Manufacturing Facility in Switzerland 

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

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

FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.

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