Shots:
CivicaScript announced plans to distribute the biosimilar ustekinumab-aauz for CICs incl. plaque PsO, PsA, Crohn’s disease, and ulcerative colitis, with its launch anticipated on Jan 01, 2026
Ustekinumab-aauz targets IL-12 & 23, helping regulate immune and inflammatory responses. Produced by Fresenius Kabi, it will be exclusively distributed by CivicaScript in the US and is interchangeable with…
NEWS
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…
Shots:
Turbine has entered into a research collaboration with Merck to simulate hard-to-treat cancer pts populations that are challenging to study in traditional lab settings
As per the deal, Meck will leverage Turbine's Simulated Cells to develop virtual tumor models that mimic hard-to-study, treatment-resistant subtypes to validate novel targets, biomarkers, & combination therapies
Collaboration includes…
Shots:
Materna Medical has completed enrolment in its EASE trial of Ellora Obstetrical System (formerly Materna Prep device) for first-time mothers
Trial will evaluate safety & effectiveness of the Ellora System vs SoC in 420 first-time mothers for the reduction of pelvic muscle injury during vaginal delivery; EASE trial will support the upcoming US FDA’s…
Shots:
The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC)
Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC
Additionally, Anbogen is pursuing global licensing,…
Shots:
Roche has reported data from the ongoing OLE P-III (Portal) study of Susvimo (port delivery platform with Lucentis) for the treatment of nAMD
The P-III (Archway) trial assessed Susvimo (Q6W refill, n=248) vs Lucentis (QM, IVT, n=168) in 415 nAMD pts responsive to prior anti-VEGF therapy; 352 entered the Portal OLE study, where 132…
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…
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…
Shots:
The US FDA has granted 510(k) to both TalisMann & StimTrial for the management of chronic pain; limited US launch is planned in Q3’25, with broader rollout expected in early 2026
TalisMann integrates patented electric field conduction with a pulse generator to target deeper, larger nerves, & deliver long-term relief from chronic nerve pain,…
Shots:
Vir Biotechnology has enrolled the first pts in P-III (ECLIPSE 2) trial assessing tobevibart + elebsiran in CHD pts who have not achieved undetectable HDV RNA despite prior bulevirtide treatment
Trial will assess CHD pts treated with bulevirtide for ≥24wks., randomized to either switch to tobevibart + elebsiran or continue bulevirtide, with the 1EP…

