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NEWS

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…
October 23, 2025

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Biocon Biologics
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Biocon Biologics Receives Health Canada Approval for Yesintek & Yesintek IV (Biosimilar, Stelara)  

Shots:  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…
October 23, 2025

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NEWS

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…
October 23, 2025

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NEWS

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…
October 23, 2025

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NEWS

Takeda Partners with Innovent Biologics to Boost Oncology Pipeline with Advanced Solid Tumor Therapies

Shots: 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…
October 23, 2025

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NEWS

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…
October 22, 2025

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Sanofi
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Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots: 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…
October 22, 2025

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NEWS

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos. Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…
October 21, 2025

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