You are here: Industry Insights > Regulatory Affairs

News List

Japanese regulators hand first global approval to AbbVie, Boehringer Ingelheim's IL-23 inhibitor Skyrizi firstwordpharma
March 27, 2019
AbbVie announced Tuesday that the Japanese Ministry of Health, Labour and Welfare approved Skyrizi (risankizumab) for the treatment of plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who have an
KOL Views: What to make of oral semaglutide’s performance in PIONEER 6? firstwordpharma
November 27, 2018
Novo Nordisk reported top-line results from the Phase III PIONEER 6 trial showing that oral semaglutide achieved an encouraging but non-significant reduction in major
Tasly and Mesoblast Initiate Development and Regulatory Activities for MPC-150-IM Heart Failure Cell Therapy in China firstwordpharma
November 27, 2018
Tasly Pharmaceutical Group and Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that the first Joint Steering Committee (JSC) meeting for their cardiovascular partnership
Akorn Receives Product Approval (Ref: GlobeNewswire) firstwordpharma
November 27, 2018
Akorn, Inc. (Nasdaq: AKRX), a leading specialty generic pharmaceutical company, announced that it received a new Abbreviated New Drug Application (ANDA) approval from the U.S. Food
US clears Loxo Oncology, Bayer's Vitrakvi for tumours driven by NTRK gene fusion, regardless of location firstwordpharma
November 27, 2018
The FDA announced Monday that it granted accelerated approval for Loxo Oncology and Bayer's Vitrakvi (larotrectinib) to treat adult and paediatric patients whose cancers have
IMDRF to launch new cybersecurity harmonization working group, criteria for accepting standards fiercebiotech
September 28, 2018
The new working group, co-chaired by the U.S. and Canada, aims to produce an international guidance document that provides regulatory definitions on the critical aspects of cybersecurity.
James Mullen backs Vicarius’ $22M series A to equip ex-Biogen, Elan team to offer U.S. biotechs a ro fiercebiotech
August 15, 2017
This model is intended to address some of the difficulties U.S. biotechs face in Europe.