Drug Development Pharma - May 22, 2018
Novo Nordisk increases its focus on stem cell-based therapies
The Danish pharma company has announced an increased commitment to stem cell-based therapies, something made possible through a collaborations with the University of California San Francisco (UCSF) in which a first milestone in the development of human embryonic stem cell lines has been reached. Under the terms of the agreement with UCSF, Novo Nordisk has licenced […]
Drug Development Pharma - May 21, 2018
Regulatory submission in Japan for AstraZeneca
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Forxiga (dapagliflozin), a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). The Japan sNDA is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients […]
Drug Development Pharma - April 4, 2018
Biologics License Application approval for AstraZeneca
AstraZeneca and MedImmune has announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. The […]
Drug Development Pharma - February 8, 2018
New data from Sobi
Swedish Orphan Biovitrum will present new evidence at the upcoming 11th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), in Madrid, Spain, 7-9 February 2018. These data mark the company´s commitment to elevate haemophilia management and expand the available clinical evidence for Elocta and Alprolix, demonstrating the need to rethink the current concept […]
Drug Development Pharma - January 29, 2018
BerGenBio shows encouranging results
BerGenBio announces the presentation of data from its broad phase II clinical development programme with its selective AXL inhibitor bemcentinib (BGB324) in two posters at the ASCO-SITC Clinical Immuno-Oncology Symposium (January 25-27, San Francisco, CA, USA). One poster outlined favourable interim safety data from three phase II clinical trials with bemcentinib in combination with KEYTRUDA (pembrolizumab), […]
Clinical Trials - January 23, 2018
FDA accepts Sobi’s IND application
Swedish Orphan Biovitrum announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition, SOBI003 was granted Fast Track status by the FDA. SOBI003 is a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA […]
