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Cardiovascular

Set Alert for Cardiovascular

Pfizer And Ionis’s Antisense Cholesterol Candidate Sparks Safety Worries

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

Clinical Trials Cardiovascular

REMS For Mavacamten Could Involve Additional Monitoring, BMS Says

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. 

FDA Safety

Earlier R&D Programs, Maturing Candidates Emerge From Bristol’s Pipeline

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.

Strategy Cardiovascular

Bristol’s Bold Projections Grow Bolder As Confidence In R&D Programs Rises

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.

Launches Strategy

AstraZeneca’s mRNA-Based AZD8601 Succeeds At Phase II, Propelling Moderna Into Heart Space

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.

Clinical Trials Cardiovascular

BI And Lilly Eye Acute Heart Failure Opportunity For Jardiance

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.

Cardiovascular Clinical Trials

Merck's Oral PCSK9 Inhibitor Could Pose A Future Threat After Early Trial Success

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

Cardiovascular Clinical Trials

Bayer Backs Hot Flashes Drug For Blockbuster Status

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.

Sales & Earnings Business Strategies

Merck Extends Timeline On Acceleron Deal, Still Expects Q4 Close

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.

Deals M & A

Cosentyx And Entresto Keep Powering Novartis As Firm Mulls Sandoz Sale

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.

Sales & Earnings Business Strategies

Acceleron Investors Want Merck To Pay More, Ask Company To Wait For Better Offer

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.

Deals M & A

Q3 Review: Editor’s Picks Of Scrip's Top Stories

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.

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