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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…
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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
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Health Canada has approved Rinvoq (15mg; QD) as a monotx. & in combination with corticosteroid to treat adults with giant cell arteritis (GCA)
Approval was based on P-III (SELECT-GCA) trial assessing Rinvoq, where GCA pts (n=428) in 1st study period received either Rinvoq (7.5 or 15mg, QD) + 26wk. corticosteroid (CS) taper regimen or PBO +…
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AbbVie has signed a definitive agreement to acquire Gilgamesh Pharmaceuticals’ Bretisilocin for moderate-to-severe major depressive disorder (MDD), currently in clinical development
As per the deal, AbbVie will acquire Gilgamesh’s bretisilocin program for ~$1.2B, including upfront and milestone payments. Gilgamesh will spin off Gilgamesh Pharma Inc. to retain its team and other programs, including blixeprodil…

