Press Releases

Regeneron Pharmaceuticals, Inc. announced that the U.S. FDA has accepted for Priority Review a Biologics License Application (BLA) for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). Evinacumab is the first investigational...

Pfizer Inc. announced a multi-year agreement with Gilead Sciences, Inc. to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Under the...

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that it was approved by the U.S. FDA to produce commercial drug substance intermediate...

Novel and generics pharma producer OncoGenerix and Alpha Capital LLC have come to an agreement to build a new injectable pharmaceutical factory in the US. The production facility will serve as an affiliate factory, similar to the one that...

Grand River Aseptic Manufacturing, a leading parenteral contract development and manufacturing organization (CDMO), has been selected by the U.S. Department of Health and Human Services and the U.S. Department of Defense to support the expansion of the United States’...

AGC Biologics, a global biopharmaceutical CDMO, announced it has expanded its partnership with Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases. AGC Biologics is currently preparing to manufacture Matrix-M™, the adjuvant component of Novavax’...

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S....