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Sandoz
News
Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia) 
Shots:  The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards  The EC’s approval was supported by the clinical evaluations…
June 23, 20250Comments
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, 20250Comments
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, 20250Comments
THOUGHTSPOT
How Stem Cell Treatment Can Boost Your Sexual Health
Millions of individuals globally face sexual health issues that influence not just their physical condition but also their emotional connections and overall life satisfaction. Although conventional therapies have some benefits, regenerative medicine creates fresh opportunities for those pursuing more successful treatments.  Stem cell treatment presents an innovative method that utilizes the body's inherent recovery processes…
June 20, 20250Comments
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, 20250Comments
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, 20250Comments
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, 20250Comments