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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:   Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)  Read More: Roche   Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma  Read…
August 8, 2025

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Bracco
NEWS

Bracco Imaging Reports the NMPA’s Approval of SonoVue for Assessment of Fallopian Tube Patency

Shots: China’s NMPA has approved SonoVue for use in hysterosalpingo contrast sonography (HyCoSy) to detect tubal issues & uterine problems A meta-analysis of 24 studies in 1358 women with infertility & 2661 fallopian tubes showed superior diagnostic performance of HyCoSy with SonoVue, with pooled sensitivity of 93%, specificity of 90%, & accuracy of 96% vs…
August 7, 2025

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NEWS

Jazz Pharmaceuticals Reports the US FDA’s Approval of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma 

Shots:  The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial  Approval was based on data from 50 pts across 5 studies, showing…
August 6, 2025

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NEWS

The US FDA Grants Fast Track Designation to Revalesio’s RNS60 for Treating Acute Ischemic Stroke

Shots: The US FDA has granted FTD to RNS60 (oxygen-enriched saline) for the treatment of acute ischemic stroke Designation was based on extensive preclinical data & P-II (RESCUE) trial, which showed reduced brain tissue loss, improved functional outcomes, & shorter hospital stays in pts treated within 24 hours of stroke onset Additionally, Revalesio is planning…
August 4, 2025

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NEWS

Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

Shots: Visirna Therapeutics, a subsidiary of Arrowhead, has granted Sanofi exclusive rights to develop & commercialize plozasiran for treating familial chylomicronemia syndrome (FCS) & severe hypertriglyceridemia (SHTG) in Greater China As per the deal, Visirna will receive $130M upfront & ~$265M in milestone payments across indications, along with net sales-based royalties in Greater China, as…
August 4, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 28, 2025 – Aug 01, 2025)  

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Animal Health and Biosimilars. Check out our full report below:     Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients  Read More: Memo therapeutics  Eli Lilly Reports Topline P-III (BRUIN…
August 1, 2025

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NEWS

BeOne Medicines’ BGB-16673 Receives the EMA’s PRIME Designation to Treat Waldenstrom’s Macroglobulinemia

Shots: The EMA has granted PRIority MEdicines (PRIME) designation to BGB-16673 for the treatment of pts with Waldenstrom’s macroglobulinemia (WM), who previously were treated with a BTK inhibitor Designation was based on data showing BGB-16673’s novel ability to degrade both wild-type & mutant BTK forms, incl. resistance-linked variants, which demonstrated anti-tumor activity in B-cell malignancies…
August 1, 2025

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