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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…
NEWS
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Biocon Biologics has received Health Canada’s NOC for Yesintek & Yesintek IV, biosimilars to Stelara, with approval on Oct 17 and commercial availability expected in mid-October
Approval was supported by data showing YESINTEK is highly similar to Stelara with no meaningful differences in efficacy, safety, or immunogenicity. It will be offered via the My…
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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…
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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…
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Takeda & Innovent Biologics have entered into a global Partnership (Excluding Greater China) to develop & Commercialize IBI363 & IBI343; Takeda also Gains exclusive Option to license global rights for IBI3001 outside of Greater China
As per the deal, Takeda will pay Innovent $1.2B upfront, including a $100M equity investment, funded from cash on…
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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…
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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…
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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…
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The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…
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The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor
Trial met its 1EP of improved PFS by 38% (mPFS:…

