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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…
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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…