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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, 20250Comments
NEWS
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, 20250Comments
Novo-Nordisk
NEWS
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, 20250Comments
INSIGHTS+
Disease of the Month – Urticaria
Shots:  Characterized by an itchy skin rash, urticaria, commonly known as hives, is often triggered by allergic reactions to food, medications, or contact with irritants.   PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions affecting communities across the globe. This monthly feature provides a comprehensive overview of each disease,…
July 31, 20250Comments