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Samsung Bioepis
News

Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab)

Shots:The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: Xgeva) for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to…
February 17, 20250Comments

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Astrazeneca
News

AstraZeneca Presents Post-Hoc Data from P-III (NIAGARA) Trial of Imfinzi in Muscle-Invasive Bladder Cancer Patients regardless of Complete Pathology Response at ASCO GU 2025

Shots:The P-III (NIAGARA) trial assessed Imfinzi (4 cycles + neoadj. CT; then 8 cycles alone) vs CT with surgery in MIBC pts ± pCR; ongoing regulatory review in the US, EU, Japan & other areas Trial met its 2EPs of improved MFS (75.1% vs 65.1%) & DSS (89.2% vs 82.2%) in ITT pts (N=1063)…
February 17, 20250Comments

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ONO Pharma
News

Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

Shots:The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs…
February 17, 20250Comments

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Anivive
News

Anivive Lifesciences Completes Pivotal Field Study of Laverdia-CA1 (Verdinexor Tablets) for Canine Lymphoma

Shots:Anivive has reported completion of its pivotal trial of Laverdia-CA1 to treat dogs with lymphoma where, the final study site was closed on Dec 12, 2024 The trial assessed Laverdia-CA1 vs PBO in dogs (n=150; selected via AniviveTrial platform from >700 applications) in 12 US sites with results expected in coming months Additionally,…
February 17, 20250Comments

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Viewpoints_Mina Makar
VIEWPOINTS

Curbing Misfolded TTR with RNA Therapy: Mina Makar from AstraZeneca in a Stimulating Conversation with PharmaShots

Shots: Misfolded TTR can lead to chronic conditions like ATTRv-PN or ATTR-CM. AstraZeneca’s Wainua (eplontersen) is a once-a-month RNA-targeted medication that suppresses TTR production Mina Makar SVP and Commerical Lead of the Global Cardiovascular, Renal, and Metabolism (CVRM), Biopharmaceuticals Business Unit at AstraZeneca, sheds light on eplontersen and its ongoing P-III clinical trial on ATTR-CM …
February 17, 20250Comments

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Samsung Bioepis
News

Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva)

Shots:The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from…
February 16, 20250Comments

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Weekly Snapshot

PharmaShots Weekly Snapshots (February 10th, 2025 – February 14th, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health & Biosimilars. Check out our full report below:   Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn's Disease Read More: Eli Lilly Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration Read…
February 14, 20250Comments

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