Cardiovascular
With the help of a purchased priority review voucher, the drug looks likely to become the first aldosterone synthase inhibitor to receive regulatory authorization, ahead of Mineralys' lorundrostat.
Successful stroke data on the oral Factor XIa inhibitor represents the first Phase III success for the class and is a major boost for Bayer’s cardiovascular franchise.
Redemplo is Arrowhead’s first commercial product, and the drug will enter a competitive market. Arrowhead and Ionis have taken different pricing paths, however.
A Phase II trial testing Winrevair in patients with a type of hypertension caused by heart failure met the primary endpoint and could represent a big growth opportunity.
Two Phase III trials of the Factor XIa inhibitor milvexian are ongoing in atrial fibrillation and secondary stroke prevention, but BMS and partner J&J stopped a third in acute coronary syndrome.
CEO Bill Anderson tells Scrip that the German group looks at potential in-licensing opportunities across every stage of the pipeline “but as you know, good value is a lot harder to come by in the late stage.”
Detailed clinical trial data presented at AHA positions the oral PCSK9 inhibitor on par with injectable drugs on efficacy, but the competitive dynamics remain intense.
Phase III CORE and CORE2 results presented at the AHA meeting in severe hypertriglyceridemia showed durable triglyceride lowering and reductions in acute pancreatitis across patient subgroups, supporting expansion of Tryngolza (olezarsen) into a second, larger indication.
Cardiologists know PCSK9 inhibition is a powerful LDL-lowering tool and now Amgen’s VESALIUS data show it may be worth adding to the primary care physician’s toolbox for prevention of high-risk patients’ first major cardiovascular events.
The company reported that a patient went to the emergency room after experiencing grade 4 transaminase elevations, which unlike a similar event in May caused symptoms.
Ionis showcased its first two wholly owned launches and plans for two more independent launches in 2026 during a recent pipeline and portfolio review.
A second Phase III win for the investigational hypertension drug will help convince analysts that AstraZeneca can reach $80bn sales by 2030, but more pivotal trial successes will be needed over the next few years.
The drugmaker said it would make the PCSK9 inhibitor available to patients directly, just days after announcing positive data in patients without histories of strokes or heart attacks.
The drugmaker announced positive results from a 12,000-patient Phase III study showing Repatha is effective in patients who have not experienced a CV event.
The data showed a significant reduction in worsening of disease conditions among recently diagnosed patients in the Phase III HYPERION trial.
India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.
The removal of a lower-dose version of a drug with years of patent-protected sales remaining in favor of a higher dose, lower-pill count version was billed as a convenience enhancement for patients. Payers, however, do not reimburse convenience.
As its biggest seller Entresto succumbs to generic competition.
Novartis is acquiring Tourmaline Bio for $1.4bn to gain pacibekitug, a promising IL-6 inhibitor for cardiovascular disease, setting up a direct rivalry with Novo Nordisk’s ziltivekimab.
Deal Snapshot: Hengrui makes its third potential billion-dollar licensing deal of 2025, this time sending rights to Phase III hypertrophic cardiomyopathy drug HRS-1893 to Braveheart.