All articles by Manish Kumar
Manish Kumar
FDA accepts BLA for Alvotech’s Eylea biosimilar AVT06 review
Alvotech is developing AVT06 and AVT29, two investigational biosimilars for Eylea, targeting the 2 mg and 8 mg HD doses, respectively
KYORIN and Cyrano Therapeutics partner to advance CYR-064
Agreement Provides Cyrano Therapeutics with Upfront and Milestone Payments, Plus Royalties from Commercialization of CYR-064 in Japan
Rznomics gains FDA fast track status for cancer drug candidate RZ-001 in HCC
RZ-001, currently in Phase 1b/2a cancer trials, has received its second fast track designation from the FDA, with the first granted for glioblastoma treatment
Innate Pharma’s lacutamab gets FDA breakthrough status for Sézary syndrome
The designation was based on positive Phase 1 and 2 TELLOMAK results, in which the drug showed promising efficacy and safety in patients with Sézary Syndrome
Fosun Pharma deeply embraces AI, self-developed PharmAID platform boosts efficient innovation
Fosun Pharma is accelerating the deeper application of AI technology in marketing, customer service, and smart office solutions, using AI to improve quality and efficiency while promoting enhanced corporate management effectiveness
Samsung Bioepis secures FDA approval for Denosumab biosimilars Ospomyv and XBRYK
The company’s denosumab biosimilars, referencing Amgen’s Prolia and Xgeva, have received FDA approval with a provisional determination for interchangeability
FDA approves GSK’s Penmenvy vaccine for meningococcal disease in adolescents and young adults
The vaccine combines GSK’s Bexsero and Menveo components, targeting MenB and MenACWY, to offer broader protection in fewer doses
New five year Sotyktu data show consistent safety and durable response rates
No new safety signals observed at Year 5 in the POETYK PSO long-term extension trial, consistent with the established Sotyktu safety profile
Novartis gets Health Canada approval for Fabhalta in PNH treatment
Fabhalta is Canada’s only Factor B inhibitor, providing comprehensive control of RBC destruction by targeting the alternative complement pathway
Pfizer’s Talzenna-Xtandi combo extends survival in prostate cancer trial
The combination therapy showed a significant improvement in overall survival, regardless of HRR mutation status, in 1,032 mCRPC patients