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Nov 1, 2024
On 1 November 2024, Novo Nordisk announced positive results from part 1 of a pivotal phase 3 study evaluating the effects of once-weekly semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis....
Oct 31, 2024
On 31 October 2024, New Zealand’s drug funding body, Pharmac, announced that it is seeking feedback on a proposal to broaden the reimbursement for Amgen’s denosumab products Xgeva® and Prolia®. Both Xgeva® (70mg/ml solution for injection, for various bone-related...
Oct 31, 2024
Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of...
Oct 31, 2024
Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care Excellence (NICE) as a NHS treatment option for wet age-related macular degeneration (AMD)....
Oct 31, 2024
On 31 October 2024, Daewoong Pharmaceutical announced that it has entered a joint sales agreement with Celltrion under which the two companies will jointly promote Celltrion’s CT-P41, biosimilar to Amgen’s Prolia® (denosumab), in Korea. CT-P41 is scheduled to be...
Oct 30, 2024
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...
Oct 30, 2024
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...
Oct 30, 2024
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...
Oct 30, 2024
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...
Oct 30, 2024
Following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen earlier in October 2024, Amgen confirmed during its earnings call on 30 October 2024 that it has launched Pavblu®/aflibercept (biosimilar to...
Oct 30, 2024
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...
Oct 29, 2024
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...
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