Drug Development Pharma - December 5, 2016
Lundbeck submitts New Drug Application to FDA
H Lundbeck and Otsuka Pharmaceutical Co have announced that the US Food and Drug Administration (FDA) has determined that the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena for the maintenance treatment of Bipolar I disorder in adult patients is sufficiently complete to permit a substantive review and is considered filed. […]
Drug Development Pharma - October 24, 2016
Sobi’s SOBI003 granted orphan designation
Swedish Orphan Biovitrum has been granted orphan designation by the European Commission (EC) for the company’s development product candidate SOBI003, a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). SOBI003 will be included in the EU Community Register of Orphan Medicinal Products. MPS IIIA or Sanfilippo A syndrome […]
Drug Development Pharma - September 6, 2016
New findings from Nordic Nanovector
Nordic Nanovector announces that two papers recently published in The Journal of Nuclear Medicine have shown that pre-dosing with the anti-CD37 antibody lilotomab (previously referred to as HH1), prior to injection with Betalutin (177Lu-lilotomab) reduces haematological toxicity without adversely impacting the amount of radiation absorbed by the tumour. Betalutin is a novel anti-CD37 antibody-radionuclide-conjugate (ARC) […]
Drug Development Pharma - August 24, 2016
Genmab announces European Regulatory Submission
Genmab announced yesterday that Janssen Pharmaceutica has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received at least one prior therapy. The submission of the application triggers milestone payments […]
Drug Development Pharma - August 23, 2016
AZ, Lilly receive fast track designation
AstraZeneca and Eli Lilly and Company have received US Food and Drug Administration (FDA) Fast Track designation for the development programme in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. The FDA’s Fast Track programme is designed to expedite the development and review of new […]
Drug Development Pharma - August 22, 2016
Lundbeck’s Idalopirdine granted Fast Track Designation
Lundbeck and Otsuka Pharmaceutical Development & Commercialization has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational agent idalopirdine for the treatment of mild to moderate Alzheimer’s disease. Idalopirdine is a selective 5HT6 receptor antagonist with a different hypothesized mechanism of action than currently available Alzheimer’s medications. […]
