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NEWS

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots: The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…
July 2, 2025

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Valorum Biologics and Formycon
NEWS

Valorum Biologics and Formycon Collaborate to Commercialize FYB203 (Biosimilar, Eylea) Across US and Canada 

Shots:  Formycon has reported that Klinge Biopharma, holder of global rights to FYB203/Ahzantive (aflibercept-mrbb), has signed an exclusive licensing deal with Valorum Biologics for commercialization across the US and Canada  As per the deal, Klinge will receive upfront, milestone, and royalty payments on net sales. Formycon will receive a mid-single—to low-double-digit percentage of all payments…
June 25, 2025

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NEWS

Harbour BioMed Enters a ~$670M Partnership with Otsuka Pharmaceutical to Advance HBM7020 for Autoimmune Diseases

Shots: Harbour BioMed & Otsuka Pharmaceutical have entered into a global strategic collaboration to advance HBM7020 for the treatment of autoimmune diseases As per the deal, Otsuka will receive an exclusive global license to develop, manufacture, & commercialize HBM7020 excl. Mainland China, Hong Kong, Macau & Taiwan in exchange for $47M in upfront & near-term…
June 23, 2025

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Bio-Thera New
NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots: The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…
June 23, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)   

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:    Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma  Read More: J&J  Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…
June 20, 2025

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NEWS

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots: Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025) Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…
June 20, 2025

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GSK New
NEWS

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…
June 20, 2025

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NEWS

Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation 

Shots:  The CHMP has recommended Imreplys (sargramostim) to treat pts of all ages with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS) following myelosuppressive radiation exposure, across the EU, Norway, Iceland, and Liechtenstein  Sargramostim is a recombinant human GM-CSF produced using yeast (S. cerevisiae) expression technology  In 2018, the same formulation was approved by the US…
June 20, 2025

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