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Aytu and Fabre-Kramer
News
Aytu BioPharma Collaborates with Fabre-Kramer Pharmaceuticals to Commercialize Exxua (Gepirone) in the US for Major Depressive Disorder
Shots:Aytu has collaborated with Fabre-Kramer to commercialize Exxua in the US for treating major depressive disorder; launch is expected in Q4’25As per the deal, Fabre-Kramer has received $3M upfront & is eligible to receive $3M within 45 days of the Exxua’s 1yr. commercial sale, increasing to $5M if net sales reach $35M as…
June 9, 20250Comments
Samsung Bioepis ans NIPRO
News
Samsung Bioepis Collaborates with NIPRO to Commercialize Biosimilar Candidates in Japan 
Shots:Samsung Bioepis & NIPRO have entered into a license, development & commercialization agreement for various biosimilar candidates, incl. SB17, a biosimilar version of Stelara (ustekinumab) in JapanAs per the deal, NIPRO will be responsible for commercialization of the biosimilar candidates in Japan, with Samsung Bioepis handling development, manufacturing & supply activitiesUstekinumab is…
June 9, 20250Comments
Arvinas and Pfizer
News
Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer
Shots:FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapyNDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapyTrial showed improved PFS (1EP) by 43%…
June 9, 20250Comments
Uncategorized Weekly Snapshot
PharmaShots Weekly Snapshots (Jun 02, 2025 – Jun 06, 2025)   
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, COVID-19 & Animal Health. Check out our full report below:   AstraZeneca Presents P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for G/GEJ Cancers at ASCO 2025 Read More: AstraZeneca Novartis Reveals Interim P-III (PSMAddition) Trial Data of Pluvicto…
June 6, 20250Comments
News
Otsuka Pharmaceutical Reports Interim P-III (VISIONARY) Trial Data of Sibeprenlimab for Immunoglobulin A Nephropathy (IgAN)
Shots:Otsuka Pharmaceutical has reported interim P-III (VISIONARY) trial data evaluating sibeprenlimab (400mg, SC, Q4W) vs PBO in ~510 IgAN pts, who were on SoC therapyTrial showed a 51.2% reduction in 24hr. uPCR (1EP) at 9mos. (presented at ERA 2025) & will continue to assess kidney function (2EP) via eGFR over 24mos., with completion…
June 6, 20250Comments
News
Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil
Shots:Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned through early…
June 6, 20250Comments