NLS Drug Development Pharma

Genmab has announced that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior […]

For the first time, researchers have revealed the nanostructure of the mesoporous magnesium carbonate Upsalite and pore size control was achieved without organic templates or swelling agents. By controlling the pore structure of the material the amorphous phase stabilisation exerted on poorly soluble drug compounds can be tuned and the drug delivery rate can be […]

PCI Biotech has announced that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) for its lead product candidate, fimaporfin, for the treatment of cholangiocarcinoma (bile duct cancer). COMP’s positive opinion is subject to decision by the European Commission for Orphan Designation. Fimaporfin (AmphinexTM) is in clinical […]

Novo Nordisk has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. IDegLira is a once-daily, single injection fixed combination of insulin degludec (Tresiba) and liraglutide (Victoza) for the treatment of adults […]

Genmab has announced that the European Commission (EC) has granted a conditional marketing authorization for first-in-class CD38 antibody DARZALEX (daratumumab). The conditional approval is for the use of DARZALEX as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and […]

Swedish Orphan Biovitrum and Biogen has announced that the European Commission (EC) has approved Alprolix (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people […]