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Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly...

Sandoz announced that it will invest US$90M to build a Biosimilar Technical Development Centre in Ljubljana, Slovenia by 2026.  The site will house an end-to-end drug substance and product development centre, becoming a ‘key location’ for Sandoz’s biosimilar product develop...

Novartis announced that its Board of Directors has unanimously endorsed the proposed separation of Sandoz from the Novartis Group, by way of a spin-off planned for Q4 of 2023.  Shareholders at Novartis will have the opportunity to vote on the proposed spin-off and share cap...

BeiGene announced that the FDA has completed a GMP inspection of its tislelizumab manufacturing facility.  Tislelizumab is a PD-1 antibody and potential treatment for oesophageal squamous cell carcinoma (ESSC), and is being commercialised with Novartis.  The Company confirm...

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara®...

AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It was also approved to treat child...

Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of I...

Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions, Ltd in the District Court of Massachusetts in relation to Biogen’s BIIB800, (biosimilar tocilizumab).  Genentech alleges that Biogen’s product, manufacture...