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NEWS

Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots: The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatment AVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearance The AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney…
October 29, 2025

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Merck new
NEWS

Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear Cell Renal Cell Carcinoma (RCC)

Shots: Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomy Trial showed significantly improved disease-free survival (1EP), with OS as 2EP under evaluation; data to be presented in future & shared…
October 29, 2025

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INSIGHTS+

New Drug Designations – September 2025    

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA   The September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …
October 28, 2025

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Roche
NEWS

Roche Reports P-III (INShore) Trial Findings on Gazyva (Obinutuzumab) for Idiopathic Nephrotic Syndrome

Shots: Roche has reported the P-III (INShore) trial findings assessing Gazyva (Obinutuzumab; Wk. 0, 2, 24 & 26) vs mycophenolate mofetil (MMF; QD) in 85 pts (>2-25yrs.) with frequently relapsing or steroid-dependent nephrotic syndrome Trial met its 1EP, with more pts achieving sustained complete remission at 1yr., & certain 2EPs. Gazyva showed significant benefits in…
October 28, 2025

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NEWS

GSK Collaborates with Empirico to Advance EMP-012 Across Inflammatory Respiratory Diseases

Shots: GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012 As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
October 28, 2025

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Astrazeneca
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AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1) Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…
October 28, 2025

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Syndax
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Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots: The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…
October 28, 2025

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NEWS

Incyte Partners with Enable Injections for enFuse On-Body Delivery System

Shots: Incyte has partnered with Enable Injections to develop and commercialize specific assets in Incyte’s portfolio, incl. INCA033989, a mutCALR selective mAb, with Enable’s enFuse On-Body Delivery System As per the deal, Incyte will obtain exclusive global rights to use enFuse tech with INCA033989 for essential thrombocythemia & myelofibrosis, with potential expansion to other assets &…
October 28, 2025

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
October 27, 2025

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