News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The US Food and Drug Administration (FDA) has granted Priority Review to GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate with a decision expected in May 2023: which could make it the first vaccine approved against the virus.
ReiThera has received operational authorization from the Italian Medicines Agency (AIFA) to open a new production area at its facility near Rome for the large-scale production of viral vectors for vaccines and gene therapy.
Purdue University and the pharma company will create a scholarship program and renew their strategic research collaboration as part of the agreement.
Harro Höfliger and leon-nanodrugs GmbH (LEON) are teaming up on a manufacturing device to encapsulate mRNAs or active pharmaceutical ingredients (APIs) into lipid nanoparticles (LNPs).
IGM Biosciences is teaming up with ADC Therapeutics on a clinical trial collaboration and supply agreement to assess the combination of an IgM antibody and an ADC for the treatment of patients with relapsed/refractory (R/R) B cell non-Hodgkin’s lymphoma...