Friday, January 7, 2022 Daily Archives

Catalent hit with FDA 483 at Belgian fill and finish facility

A syringe filling facility in Brussels run by CDMO Catalent has received a US FDA Form 483 and has allegedly created supply issues for Novo Nordisk’s Wegovy. The 265,000 square-foot site described as Catalent’s flagship European syringe filling facility produces over 175 million units annually for the contract development and manufacturing organization’s (CDMO’s) customers. But a recent inspection by the US Food and Drug Administration (FDA) discovered concerns at the site and resulted in a Form 483. “We are treating…

Merck KGaA to acquire Exelead in $780m deal

Germany’s Merck will strengthen its mRNA offerings through the $780 million acquisition of CDMO Exelead. Merck will strengthen its mRNA offerings within its biopharma services division MilliporeSigma after signing a definitive agreement to acquire contract development manufacturing organization (CDMO) Exelead. Exelead specializes in injectable formulations, such as lipid nanoparticles (LNPs) used in messenger RNA (mRNA) therapeutics.  The demand for mRNA capabilities in the biopharma sector has been driven by COVID-19 vaccine success. Pfizer and BioNTech’s BNT162b2 (Comirnaty) became the first mRNA COVID-19 vaccine to receive emergency…