NEWS

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

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…

August 4, 2025

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

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,…

August 4, 2025

Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD)

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…

August 4, 2025

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

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

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

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,…

August 1, 2025

Vir Biotechnology Reports First Patient Enrolment in P-III (ECLIPSE 2) Trial of Tobevibart + Elebsiran for Chronic Hepatitis Delta (CHD)

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…

August 1, 2025

Ultragenyx Completes Patient Enrolment in P-III (Aspire) Trial of GTX-102 for Angelman Syndrome

Shots: Ultragenyx has completed enrolment in its P-III (Aspire) trial to assess GTX-102 (apazunersen) in Angelman syndrome pts with confirmation of full maternal UBE3A gene deletion; Aurora study in more ages & genotypes to begin in H2'25 Trial will evaluate GTX-102 (intrathecal, 8mg QM for 3mos., then up to 14mg Q4M) vs a sham treatment…

August 1, 2025

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

Shots: The US FDA has approved label expansion of Alhemo (concizumab-mtci) to prevent or reduce the frequency of bleeding episodes in pts (≥12yrs.) with HA/HB without inhibitors Approval was based on P-III (Explorer8) trial assessing Alhemo (n=42, 1mg/kg followed by 0.2mg/kg QD) vs no prophylaxis (n=21) in 156 males with HA/HB, where median duration of…

August 1, 2025

LENZ Therapeutics’ Vizz Receives the US FDA’s Approval to Treat Presbyopia

Shots: The US FDA has approved Vizz (1.44% aceclidine ophthalmic solution) for the treatment of presbyopia in adults; samples are expected in the US by Oct 2025, with full commercial launch by mid-Q4’25 Approval was based on the 3 P-III trials: CLARITY 1 & 2 evaluating Vizz (QD) in 466 pts for 42 days as…

August 1, 2025

NEWS

Materna Medical Reports Enrolment Completion in EASE Trial of Ellora System to Reduce Pelvic Injury from Vaginal Delivery

Anbogen Therapeutics Reports the US FDA’s IND Clearance of ABT-301 for Metastatic Colorectal Cancer

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

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

Bioventus’ TalisMann and StimTrial Secure the US FDA 510(k) Clearances for Chronic Pain Management

Vir Biotechnology Reports First Patient Enrolment in P-III (ECLIPSE 2) Trial of Tobevibart + Elebsiran for Chronic Hepatitis Delta (CHD)

Ultragenyx Completes Patient Enrolment in P-III (Aspire) Trial of GTX-102 for Angelman Syndrome

Novo Nordisk’s Alhemo Receives the US FDA’s Approval for Hemophilia A or B (HA/HB) Without Inhibitors

LENZ Therapeutics’ Vizz Receives the US FDA’s Approval to Treat Presbyopia

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