News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.
Donaldson Company will acquire Isolere Bio: an early-stage biotech that develops novel and proprietary ‘IsoTag’ reagents and accompanying filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals.
The US Food and Drug Administration (FDA) has accepted Pfizer’s Biologics License Application (BLA) for its maternal RSV vaccine under priority review. If approved, the vaccine will become the first RSV vaccine for pregnant women to protect against RSV...
Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.