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Feb 26, 2024
On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn's & Colitis 360. The study involved 108 patients switched from IV to a subcutaneous vedolizumab. The results of the study suggested that switching...
Feb 26, 2024
On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept). This is the first aflibercept biosimilar approved in Korea and...
Feb 26, 2024
On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share. Alvotech's U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved...
Feb 23, 2024
On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden. The results demonstrate SB17 is highly similar...
Feb 23, 2024
Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®. SIMLANDI® is the first high concentration adalimumab product to be US approved. It is...
Feb 23, 2024
On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this year. This news comes after Phase 3 clinical trial results...
Feb 23, 2024
On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®'s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target...
Feb 22, 2024
On February 2024, Artiva Biotherapeutics announced that the FDA granted fast-track designation to its Lupus Nephritis treatment AlloNK®(AB-10) in combination with rituximab or obinutuzumab. This was supported by the results of a phase I/II multicentre clinical trial...
Feb 22, 2024
AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell's portfolio notably includes GC012F a clinical stage chimeric...
Feb 22, 2024
On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar). Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis,...
Feb 21, 2024
Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested...
Feb 21, 2024
On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab). The results came from a double blinded, randomised, single dose study which...
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