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Astrazeneca & Daiichi Sankyo
Daiichi Sankyo and AstraZeneca Report the CHMP Positive Opinion for Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: The CHMP has recommended Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis Opinion was backed by the global P-III (TROPION-Breast02)…
LENZ Therapeutics Partners with Arrotex Pharmaceuticals to Commercialize Vizz in Australia and New Zealand
Shots: LENZ has entered into an exclusive license & commercialization agreement with Arrotex to register & commercialize Vizz (aceclidine ophthalmic solution) 1.44% for the treatment of presbyopia in Australia & New Zealand As per the deal, Arrotex will obtain exclusive commercialization rights for Vizz for the treatment of presbyopia in Australia & New Zealand. In return,…
Chiesi Group and Arbor Biotechnologies Secure the EC’s Orphan Drug Designation for ABO-101 to Treat Primary Hyperoxaluria
Shots: The EC has granted ODD to ABO-101 for the treatment of primary hyperoxaluria ABO-101 is being evaluated in an open-label global P-I/II (redePHine) study assessing safety, tolerability, PK/PD, & preliminary efficacy of a single dose of ABO-101 in pts with PH type 1 ABO-101 is a one-time, liver-directed gene-editing therapy that uses an Acuitas-licensed…
CStone Pharmaceuticals Partners with Arrotex to Commercialize Sugemalimab across Australia and New Zealand
Shots: CStone Pharmaceuticals has entered into an exclusive commercialization agreement with Arrotex for the commercialization of sugemalimab in Australia & New Zealand As per the deal, Arrotex will be responsible for regulatory submissions & obtain exclusive commercialization rights for sugemalimab in Australia & New Zealand across all approved & future indications In return, CStone will…
Merck KGaA to Acquire Bio-Techne for ~$11.3B
Shots: Merck KGaA has entered into a definitive agreement to acquire Bio-Techne, bringing together two companies with complementary portfolios spanning research tools, diagnostics, bioprocessing, and advanced therapeutics As per the deal, Merck KGaA will acquire Bio-Techne for $73/share in cash, representing a total enterprise value of ~$11.3B; closing is expected by late 2026 or early…
Ionis Inks ex-US Deal with Recordati for Zilganersen in Alexander Disease
Shots: Ionis has granted Recordati exclusive rights to develop & commercialize zilganersen for Alexander disease outside the US, while Ionis retains US commercialization rights & will continue to lead global development Ionis will receive $30M upfront & additional milestone payments, with tiered royalties of up to the mid-20% range on annual net sales. Recordati will…
Otsuka Reports P-IIIb Trial Data on Centanafadine in ADHD and Comorbid Anxiety
Shots: Otsuka has reported topline P-IIIb trial results evaluating centanafadine XR (280mg, QD) vs PBO in 315 adults (18-65yrs.) with attention-deficit/hyperactivity disorder (ADHD) & comorbid generalized anxiety disorder and/or social anxiety disorder The trial met its 1EP, with AISRS total score improvement at Wk. 8 (-18.5 vs -12.6), evident from Wk. 1 & sustained throughout the…