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AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura)
Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…
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In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…
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The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy
Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in…
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Chiesi Group has entered into an exclusive license deal with Aliada Therapeutics, an AbbVie subsidiary, to advance its Blood-Brain Barrier (BBB)-crossing platform technology for developing therapies targeting lysosomal storage disorders
As per the deal, Chiesi will receive an exclusive global license to develop & commercialize enzyme replacement therapies using its BBB-crossing platform, with Aliada receiving…
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AbbVie has reported topline P-III (M19-044) trial data on Rinvoq (15mg, QD, PO) in pts with non-segmental vitiligo (NSV) who were eligible for systemic therapy
Trial incl. 2 replicate studies in NSV pts (n=614; ≥12yrs.): Study 1 (206 Rinvoq, 102 PBO) & Study 2 (205 Rinvoq, 101 PBO), where in both studies' Period A, pts…
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AbbVie has reported topline P-II (ELATE) trial data assessing Botox (onabotulinumtoxinA) vs PBO in pts with upper limb essential tremor
Trial met its 1EP with improved Tremor Disability Scale-Revised scores at 18wks. & showed a greater TREDS-R total unilateral score reduction (-2.61 vs -1.61), plus it also achieved all six 2EPs; data to be…
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The US FDA has received BLA of Pivekimab sunirine (PVEK) for the treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
The BLA is backed by the P-I/II (CADENZA) trial, which evaluated PVEK monotx. to establish the MTD, RP2D, & dosing schedule, while assessing safety, tolerability, PK, immunogenicity, & antileukemia activity in pts with CD123+…
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The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study
TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…
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Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas
As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…
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Health Canada has approved Elahere under priority review to treat FRα+, Pt-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments
Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT in pts (n=453) to treat PROC expressing high levels of FRα, as determined using the Ventana…

