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Aug 13, 2024
Eisai and Biogen have announced that Leqembi® (lecanemab) has been approved for the treatment of Alzheimer’s disease in the United Arab Emirates. The approval is based on results from the global Phase III Clarity study and will allow treatment of patients with mild...
Aug 12, 2024
On 12 August 2024, Amgen filed a lawsuit with the US District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics asserting infringement of 36 patents relating to denosumab. The BPCIA litigation reportedly follows the filing by Samsung...
Aug 12, 2024
On 12 August 2024, Sandoz formally announced the introduction of Jubbonti® and Wyost® in Canada via its Canadian website. We previously reported in July 2024 Sandoz’s (informal) announcement via Linkedin that the company had launched its denosumab biosimilar Wyost®...
Aug 12, 2024
On 12 August 2024, Celltrion announced that its high concentration, buffer free (100mg/ml) adalimumab, biosimilar to AbbVie’s Humira®, is now on the Costco member prescription program. The Celltrion buffer free product was FDA approved on 23 May 2023 and was launched...
Aug 12, 2024
On 12 August 2024, Sandoz announced that the FDA has approved Enzeevu™ (aflibercept-abzv) biosimilar to Regeneron’s Eylea® for nAMD. Enzeevu™ is the fourth aflibercept biosimilar to be approved in the US, following Samsung Bioepis’ Opuviz™/SB15 (May 2024), Biocon’s...
Aug 12, 2024
On 12 August 2024, Celltrion announced that the FDA has approved its phase 3 clinical trial plan for CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab). The global phase 3 trial will evaluate the effectiveness of CT-P51 and its and equivalence with Keytruda® in...
Aug 12, 2024
On 12 August 2024, Xbrane reported that it has commenced processes to out-license Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801), biosimilar to UCB’s Cimzia® (certolizumab pegol). The out-licensing process is to...
Aug 9, 2024
On 9 August 2024, Sandoz announced its Q2 2024 sales and financial results for half year ended 30 June 2024, reporting net sales of USD 2.6 billion for Q2/24, an increase of 9% when compared to the same quarter in 2023. Net sales for biosimilars in the same period...
Aug 9, 2024
On 9 August 2024, Celltrion announced that its Zymfentra™ (infliximab-dyyb) has been included in 26 US formularies, including for 3 major Prescription Benefit Managers (PBMs), just five months after launch. According to Celltrion, the formulary listings provide 75%...
Aug 9, 2024
On 9 August 2024, New Zealand’s Pharmaceutical Medicines Agency (Pharmac) announced that it is seeking commercial bids from suppliers for the supply of bevacizumab for a range of cancers. Bevacizumab is currently funded in NZ hospitals for recurrent respiratory...
Aug 9, 2024
On 9 August 2024, MSD and Curon Biopharmaceutical announced the MSD acquisition of Curon developed CD3xCD19 bispecific antibody CN201, currently in Ph I/II trials for the treatment of B-cell associated diseases. Under the agreement, MSD will make an upfront payment...
Aug 9, 2024
Ono Pharmaceutical and Bristol-Myers Squibb have announced a supplemental application in Japan for Ono’s Opdivo® and BMS’s Yervoy® in combination therapy, to expand its approved use to the treatment of unresectable hepatocellular carcinoma (HCC). Ono’s 2011 grant to...
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