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AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Shots: The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countries Approval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
Ventus Therapeutics Partners with Genentech to Develop Small-Molecule Drugs Using ReSOLVE Platform
Shots: Ventus Therapeutics has entered a multi-year collaboration with Genentech to discover and optimize novel small-molecule drugs for major diseases using its ReSOLVE platform As per the deal, Ventus will utilize its ReSOLVE platform to identify small-molecule leads for multiple targets, while Genentech will be responsible for preclinical, clinical, and commercial development. Ventus will receive…
GSK’s Shingrix PFS Presentation Receives the CHMP’s Positive Opinion
Shots: The CHMP has recommended Shingrix in a PFS (Recombinant Zoster Vaccine or RZV), simplifying administration by eliminating vial reconstitution for the prevention of shingles (herpes zoster). EU marketing authorization is expected in December 2025 The opinion was based on data showing that the PFS matches the existing vaccine Shingrix combines glycoprotein E antigen with…
Taiho Pharmaceutical Secures Exclusive Licensing Rights for Casdatifan from Arcus Biosciences in Japan and Select Asian Territories
Shots: Taiho Pharmaceutical has exercised its option to develop & commercialize casdatifan, pending approval in Japan & other Asian regions (excl. Greater China) under Taiho & Arcus’ 2017 option & license agreement As per the deal, Arcus will receive an option exercise payment & clinical, regulatory, plus commercial milestone payments, with net sales-based royalties. Although…
Polpharma Biologics Launches Ranivisio PFS (Biosimilar, Lucentis) in the EU
Shots: Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland Ranibizumab is a recombinant humanized…
Samsung Bioepis and Phrontline Sign Global Strategic Partnership to Develop Advanced ADC Therapies for Solid Tumors
Shots:                                                                                                                                                             Samsung Bioepis and Phrontline Biopharma have entered a global agreement to develop, manufacture, and commercialize two ADC assets, including TJ108 Under the deal, Phrontline will receive an upfront payment and potential milestone payments. Phrontline will develop bispecific, dual-payload ADCs using its proprietary platforms. As part of the agreement, Samsung Bioepis received exclusive rights to…