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Nov 22, 2024
On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative...
Nov 22, 2024
On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively. Stoboclo™ and Osenvelt™ are the first...
Nov 21, 2024
On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of...
Nov 20, 2024
We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara®
Nov 20, 2024
On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected...
Nov 20, 2024
On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A without FVIII...
Nov 20, 2024
On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa. This follows the recommendation of the EMA’s Committee for Medicinal...
Nov 19, 2024
On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report states that sales will initially be made without insurance subsidy, although Novo Nordisk is investigating mechanisms to reduce costs for Chinese...
Nov 19, 2024
On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction, which was reinstated in October 2024, preventing Zydus from manufacturing, selling and marketing...
Nov 19, 2024
On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC...
Nov 19, 2024
On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate (referencing BMS’ Opdivo®). The biosimilar will be commercialised through Intas’...
Nov 19, 2024
On 15 November 2024, Canada's Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™ by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic...
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