NEWS

GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis

Shots: GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger…

August 19, 2024

Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations

Shots: The US FDA has approved J&J’s Rybrevant + Lazcluze as a 1L treatment for LA/metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations The approval was based on the P-III (MARIPOSA) assessing Rybrevant + lazertinib vs osimertinib and lazertinib alone in 1074 patients The study reached its 1EP and 2EPs…

August 19, 2024

Bio-Thera Solutions Expands its Partnership with Pharmapark for BAT2306 (Biosimilar, Cosentyx) Across Russia and Other Countries

Shots: Pharmapark will hold exclusive distribution, and marketing rights & filing for BAT2306 (Secukinumab bsm) which has finished the P-I & P-III study globally and plans to submit applications for approval to the NMPA, EMA & FDA. Under the terms of the agreement, BAT2306 will be developed & supplied by Bio-Thera at its Guangzhou, China…

August 16, 2024

EMA Accepted the Marketing Application of Alvotech’s AVT06 a Biosimilar of Eylea (aflibercept)

Shots: Alvotech reported EMA’s acceptance of its marketing application for AVT06, a biosimilar to Eylea used to treat eye disorders, and reported global sales of $5.9B. The company expects its marketing approval in Q3’25 Alvotech will develop and supply the AVT06, while Advanz Pharma will register and have exclusive commercialization rights in Europe except for…

August 15, 2024

Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD)

Shots: Based on P-II (AGAVE-201) study, Niktimvo got FDA approval to treat chronic GvHD patients who failed at least two lines of previous therapy Niktimvo patients (0.3 mg/kg, Q2W, n=79) achieved 75% ORR in 6mos. with 1.5mos. mToR; 60% maintained response at 12mos. Study also met key exploratory EPs, 56% patients achieved ≥7-point improvement in…

August 14, 2024

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Shots: Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…

August 14, 2024

Galderma Reports the US FDA’s Approval of Nemluvio (Nemolizumab) for Treating Prurigo Nodularis (PN)

Shots: The approval of Nemluvio (SC pre-filled pen) was based on P-III (OLYMPIA 1 & 2) studies assessing its safety & efficacy vs PBO in PN patients (n= >500) Studies met their 1 & 2EPs, showing at least a 4-point reduced itch intensity in 56% & 49% vs 16% (both PBO groups); skin nodules clearance…

August 13, 2024

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration

Shots: The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…

August 12, 2024

Ascendis Pharma’s Yorvipath Receives the US FDA’s Approval to Treat Hypoparathyroidism

Shots: The US FDA has approved Yorvipath (QD) tablets for treating hypoparathyroidism patients, with its initial supply planned during Q1’25 The approval was supported by the P-II (PaTH Forward) as well as P-III (PaTHway) clinical trials conducted worldwide Ascendis will further introduce the US Ascendis Signature Access Program (A.S.A.P.) for treatment support & financial assistance…

August 9, 2024

The US FDA Approves Citius Pharmaceuticals’ Lymphir to Treat R/R Cutaneous T-Cell Lymphoma (CTCL)

Shots: The US FDA has granted approval to Lymphir for treating chronic r/r CTCL in patients treated with at least one prior systemic therapy, with its introduction anticipated within the next 5mos. The approval was based on P-III (Study 302) trial assessing the safety & efficacy of Lymphir (9mcg/kg, IV) among patients (n=69) with…

August 8, 2024