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The EC has approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in pts (≥3yrs.) with compensated liver disease (with or without cirrhosis)
Approval was based on the P-III (M20-350) trial assessing Maviret (QD, PO) in pts (≥12yrs.) with acute HCV infection, enrolling 286 treatment-naïve adults across 70 locations globally
Trial…
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The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.
CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
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AbbVie entered into a definitive agreement to acquire Apogee Therapeutics for $135.11 per share in cash, at a total equity value of approximately $10.9B. The transaction is expected to close in Q3’26, subject to shareholder and regulatory approvals
The acquisition strengthens AbbVie’s immunology portfolio by adding Apogee’s clinical-stage pipeline focused on inflammatory and immunological…
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The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.
Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).
Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…
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The EC has approved AbbVie's Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura, to be taken as needed
Approval was supported by the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (60mg, PO) vs PBO as an acute treatment of migraine with or without aura in 1,328 adults (18-75yrs.)
Trial met…
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The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN
Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease
Trial reported a 69.7% composite…
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The CHMP has recommended Boey (trenibotulinumtoxinE) to improve the appearance of mod. to sev. glabellar lines in adults temporarily; decision is expected in the coming mos., & would apply across all 30 EEA states
Opinion was supported by data from 2 P-III trials assessing the efficacy & safety of Boey in adults with…
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Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones
As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…
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Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships
The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…
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Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies
As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…

