Cardiovascular

Increases in liver enzymes and fat could dampen approval prospects despite vupanorsen meeting its mid-stage primary endpoint, some analysts have said.

The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters. 

BMS is advancing a growing Phase I and II R&D pipeline, including a Factor XIa inhibitor with lower bleeding risk than current anticoagulants, as well as other internal and external research programs.

Loss of exclusivity for key Bristol Myers Squibb products, starting with top seller Revlimid, is looming over the company’s R&D pipeline. BMS believes its late-stage and newly approved products will generate more than $25bn in sales by 2029.

AstraZeneca and Moderna’s mRNA-based candidate AZD8601 has shown promise in a small Phase II heart study, strengthening the latter’s foray into the cardiovascular arena and beyond its vaccine niche.

Having strongly made the case for Jardiance as a treatment for chronic heart failure, Boehringer Ingelheim and Eli Lilly believe the SGLT2 inhibitor could have a lot of potential in acute heart failure as well after promising data from the EMPULSE study.

MK-0616 – administered orally – reduced LDL cholesterol in patients in two early clinical trials presented at the American Heart Association Scientific Sessions.

The menopause drug elinzanetant, which has just gone into Phase III, has joined Kerendia, Verquvo and Nubeqa as a candidate that Bayer believes has a peak sales potential of more than €1bn.

Merck said it is giving the FTC more time to review the acquisition, but the shift also gives the company leeway to convince any reluctant Acceleron shareholders to trade their shares for cash.

CEO Vas Narasimhan sees Novartis very much as an innovative company so the long-awaited strategic review of Sandoz suggests that the generics/biosimilars business could be spun off or sold fairly soon.

Avoro Capital, Holocene Advisors and Darwin Global say that Acceleron should sell later for a higher price based on forthcoming data or Merck should raise its bid above $180 per share.

From the latest COVID-19 advances to the emergence of a game changer for heart failure, Scrip’s editor in chief Eleanor Malone reviews the big stories of the past three months. Safety issues around JAK inhibitors and AAV vector-based gene therapy were also to the fore, while biopharma financing continued apace.