BioPharm International Editors

Artiva Biotherapeutics’s new R&D and GMP manufacturing center in San Diego, Calif., for NK cell therapies is expected to open in 2022.

Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

Primates inoculated with CV2CoV show improved immune response and protection from various COVID variants.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

PNI expands global headquarters with a new 75,000-square-foot facility, which will include multiple GMP suites for manufacturing RNA therapeutics and vaccines.

The companies announce the results of a research collaboration that applied machine learning to significantly advance the scalability of spirulina-based biologic drugs.

Rentschler Biopharma has broken ground nearby its Milford, Mass., site where it will build its new multi-product manufacturing facility for commercial production of complex molecules.

Lykan Bioscience and Vineti will combine their capabilities to streamline process development and manufacturing to move cell therapies through clinical phases to commercialization.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

A research team at the Keck Graduate Institute will work to adapt its decade-long low-cost vaccine R&D for developing countries into a COVID-19 vaccine.

A collaboration between Aldevron and Ginkgo Bioworks has resulted in a manufacturing enhancement that can improve production of an enzyme used for mRNA therapeutics.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.

Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.

The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.

FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.

AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.