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Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  This comes 5 months after the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications fo...

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants.  Celltrion reports that the study found Zymfentra™ as monotherapy was just as ...

On 30 October 2024, the US Food and Drug Administration (FDA) provided an update on its drug shortage database, reporting that all doses of Novo Nordisk’s popular weight loss injection Wegovy® and diabetes drug Ozempic® (both of which comprise semaglutide) are now available...

On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year.  Net sales for the first 9 months of the year were USD 7.6 billion, an increase of 9% in consta...

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes...

On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3...

On 29 October 2024, UK’s National Institute for Health and Care Excellence (NICE) recommended Pfizer’s Elrexfio® (elranatamab) for use in the NHS’ Cancer Drugs Fund.  The Cancer Drugs Fund provides funding for certain cancer medicines before they have been approved by NICE ...

On 29 October 2024, Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, which demonstrated that patients with early symptomatic Alzheimer’s disease (AD) who received a slightly modified titration of Kisunla™ (donanemab) showed a reduction i...

On 28 October 2024, AstraZeneca announced that the European Commission has approved its Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).  The indication received a positive r...