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NEWS

Formycon and Zydus Lifescience Report Successful Clinical Development of FYB206 (Biosimilar, Keytruda) 

Shots:  Formycon & Zydus Lifescience has reported that the pivotal Dahlia PK study of FYB206, a biosimilar version of Keytruda (pembrolizumab), has met its 1EP   The multicenter PK study showed bioequivalence of FYB206 (pembrolizumab) to Keytruda   Zydus Lifesciences has exclusively in-licensed FYB206, a proposed biosimilar to Keytruda (pembrolizumab), from Formycon for the US and Canada   Ref: Zydus Lifesciences | Image: Zydus Lifesciences and Formycon | Press Release  Related…
February 25, 2026

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Samsung Bioepis
NEWS

Samsung Bioepis’ Ustekinumab BS (Biosimilar, Stelara) Approved in Japan 

Shots:  Samsung Bioepis has received Japanese marketing approval for Ustekinumab BS 45mg syringes, a biosimilar of Stelara, under its partnership with NIPRO Corporation  Ustekinumab, a human IgG1κ antibody targeting IL-12/IL-23, is approved in Japan as ‘NIPRO’ for plaque psoriasis and psoriatic arthritis, with NHI listing expected in May 2026   It is also approved in Australia, Brazil, Canada,…
December 23, 2025

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INSIGHTS+

New Drug Designations – September 2025    

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …
October 28, 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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Sanofi
NEWS

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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INSIGHTS+

New Drug Designations – August 2025     

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA    The August 2025 report covers designations granted to 37 drugs and 4 medical devices, spanning 14 small molecules, 5 biologics, 7 cell and gene therapies & 4 medical devices, among others    Significant…
September 23, 2025

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INSIGHTS+

Key Biosimilars Events of August 2025  

Shots:        Biosimilars are developed to be highly similar of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our…
September 2, 2025

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Knight Therapeutics and Incyte
NEWS

Knight Therapeutics and Incyte Expand Latin America Agreement to Include Retifanlimab and Axatilimab

Shots: Knight Therapeutics has amended its agreement with Incyte Biosciences to gain exclusive distribution rights for retifanlimab (Brand name: Zynyz in the US and EU) and axatilimab (Brand name: Niktimvo in the US) in LATAM Under the amended deal, Incyte will develop, manufacture, and supply retifanlimab and axatilimab, while Knight will handle regulatory approvals and…
August 6, 2025

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