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Astrazeneca
NEWS

AstraZeneca Reports the US FDA’s NDA Acceptance with Priority Review of Baxdrostat for Hard-to-Control Hypertension

Shots: The US FDA has accepted NDA & granted priority review to Baxdrostat as an add-on treatment of pts with uncontrolled or treatment-resistant hypertension (PDUFA: Q2’26 following use of PRV) NDA was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with…
December 3, 2025

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Novartis
NEWS

Novartis Reports P-IV (V-DIFFERENCE) Trial Findings on Leqvio (Inclisiran) for Hypercholesterolemia

Shots: Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…
September 2, 2025

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Abbott
NEWS

Abbott’s Navitor TAVI System Receives European CE Mark for Aortic Stenosis in Patients at Low or Intermediate-Risk for Surgery

Shots: Abbott has received the CE Mark approval for Navitor transcatheter aortic valve implantation(TAVI) system to expand its use in people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery Approval was backed by VANTAGE study of Navitor TAVI, which met its safety & efficacy 1EPs in above pts Trial showed…
September 1, 2025

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Merck
NEWS

Merck Reports P-III (VICTOR) Trial Data of Verquvo (Vericiguat) for Chronic Heart Failure and Reduced Ejection Fraction (HFrEF)

Shots: Merck has reported P-III (VICTOR) trial data assessing Verquvo (n=3,053) vs PBO (n=3,052) in pts with stable chronic heart failure & reduced ejection fraction Trial did not meet its 1EPs of reducing CV death or HF hospitalization (18% vs 19.1%); however, 2EPs showed numerically lower rates of CV death (9.6% vs 11.3%) & HF…
September 1, 2025

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