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NEWS

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots: The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025 In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…
November 6, 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

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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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

Teva and Prestige Biopharma Sign a Licensing Agreement to Commercialize Tuznue (Biosimilar, Herceptin) Across EU

Shots: Teva Pharmaceuticals and Prestige Biopharma have signed a license and supply agreement to commercialize Tuznue (trastuzumab), a Herceptin biosimilar, in most European markets As per the deal, Teva will market and distribute Tuznue in most European markets, while Prestige Biopharma will handle production and supply from its EU-GMP-certified facilities Tuznue, biosimilar of Herceptin, with…
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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CuraTeQ
NEWS

CuraTeQ Biologics Reports Positive P-III study results for Denosumab biosimilar for postmenopausal osteoporosis 

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported positive P-III results for its denosumab biosimilar targeting postmenopausal osteoporosis, as an alternative to Prolia  The study involved 446 postmenopausal women across 40 sites in EU met all EPs, showing no significant differences between the biosimilar and Prolia  The trial confirmed the biosimilar's efficacy in improving…
September 19, 2025

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NEWS

STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)  

Shots:  The CHMP has recommended Kefdensis and Zvogra, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders  Kefdensis (biosimilar to Prolia) received CHMP approval for treating osteoporosis in high-risk postmenopausal women and men with an increased risk of fractures. Zvogra (biosimilar to Xgeva) received CHMP approval for preventing skeletal events…
September 19, 2025

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NEWS

Formycon and Klinge Biopharma sign a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea)  

Shots:  Formycon and Klinge Biopharma have signed a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea) in selected EC, following a similar agreement with Teva in Jan for covering major parts of the EU & Israel  Klinge will receive upfront, milestone payments, and royalties on net sales, with Formycon earning a…
September 17, 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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