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On 12 September 2024, Ono Pharmaceutical and Bristol-Myers Squibb announced they submitted a supplemental application in Japan for Ono’s Opdivo® (nivolumab) and BMS’s Yervoy® (ipilimumab) in combination therapy, to expand use to unresectable advanced or recurrent microsatel...

On 12 September 2024, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) as monotherapy for treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) so...

On 11 September 2024, Sanofi and Regeneron announced that a confirmatory phase 3 study of Dupixent® (dupilumab) met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving background t...

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Trem...

On 11 September 2024, Bio-Thera Solutions and Biogen published results from their phase 3 switching study for Tofidence™ (BAT1806/BIIB800), biosimilar to Roche’s Actemra®/RoActemra® (tocilizumab).

The study showed that comparable clinical efficacy, safety, immunogeni...

The Australian Therapeutic Goods Administration (TGA) has approved Celltrion’s SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  SteQeyma is approved for a 130 mg/26 mL concentrate for solution for infusion vial to treat moderate to severe plaque psoriasi...

On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity.  The product will reportedly use an improved form of Iconovo’s existing intranasal inhaler “ICOone Nasal®”.

I...

On 10 September 2024, Eli Lilly announced that it met the primary endpoints for A1C (blood glucose measurement) reduction in the QWINT-2 (type 2 diabetes) and QWINT-5 (type 1 diabetes) trials for once weekly insulin efsitora alfa.  The results were simultaneously published ...

On 9 September 2024, Bayer announced that the European Medicines Agency (EMA) has approved its Eylea™ (aflibercept) 8mg pre-filled syringe (PFS), “OcuClick™”, for nAMD and diabetic macular oedema (DME).  Bayer reports that Germany will be one of the first launch markets for...