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Nov 4, 2024
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the months of August, September and October. Among the new applications to be reviewed is Freyr's new application for liraglutide (Lobezyl®)....
Nov 4, 2024
On 4 November 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for AVT05, biosimilar to Janssen’s Simponi® (golimumab), for treatment of several chronic inflammatory...
Nov 4, 2024
NYSE-listed telehealth provider, Hims & Hers Health Inc, announced in its third quarter 2024 earnings conference call that it plans to bring generic liraglutide to its platform in 2025. The company says it has already confirmed a core supplier and expects to...
Nov 4, 2024
On 4 November 2024, the Korea Hearld reported that Celltrion has launched SteQeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in Germany and the Netherlands. At the same time, the Korea Herald reported that Celltrion has already secured a bid from the Dutch...
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...
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