Search Results for “cardiovascular” – Page 27 – media

Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
- Source: drugdu
- 117
- October 18, 2023
Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
- Source: drugdu
- 231
- October 18, 2023
High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. The Danish company now expects full-year sales to grow between 32% and 38% at constant exchange rates. The new projection, released on Friday, represents a 5-percentage-point increase on both ends of the range from an August estimate, which itself was 3 percentage points higher than a previous forecast from April. Novo’s share price at one point traded at around $104 on the New York Stock Exchange on Friday, a new all-time high. Huge demand for Ozempic—which is often used off-label to treat obesity—plus new discount adjustments for Ozempic and Wegovy in the U.S. drove the updated sales outlook, Novo explained in a release. Novo on Friday also dialed up its estimated profit growth rate by 9 percentage points to a range of 40% to 46%. The company released the ...
- Source: drugdu
- 194
- October 17, 2023
Interest in RNA Editing Accelerates as Therapies Approach the Clinic

By Gerard Platenburg Pictured: RNA/iStock, Artur Plawgo Based on the significant progress made over the last few decades with RNA therapeutics, RNA editing is widely considered the next generation of promising medicines in this field. RNA therapies have made significant progress over the last few years, with an increasing number of FDA approvals beginning in 1998 with Vitravene for CMV retinitis, followed by Macugen for macular degeneration in 2004 and Spinraza for spinal muscular atrophy in 2016. There have also been multiple siRNA-based drugs, including Onpattro for polyneuropathy of hereditary transthyretin-mediated amyloidosis in 2018. And finally, in 2020, perhaps the most well-known products in the RNA space were introduced: the mRNA-based COVID-19 vaccines. All of these demonstrate the strength of RNA therapies and their potential impact on diseases with high unmet need. RNA therapeutics are indeed elegant approaches to altering RNA and thus protein expression, opening the potential to target ...
- Source: drugdu
- 135
- October 17, 2023
Birmingham researchers develop nanobodies to understand platelet disorders

Researchers at the University of Birmingham have developed antibody fragments, called nanobodies, in a bid to understand platelet disorders such as thrombosis. The team at the Institute of Cardiovascular Sciences has been able to produce the first binding molecules of defined composition to make platelets clump together in a predictable way. The institute aims to use these nanobodies to develop validated clinical assays for testing patients with platelet disorders such as bleeding or thrombosis, as well as use them as a research tool to study platelet activation. The institute’s work is set to be published in the Journal of Thrombosis and Haemostasis later this week (12 October.) In previous studies carried out by the Birmingham Platelet Group, Professor Steve Watson and Dr Natalie Poulter used novel nanobodies the team had raised to bind to the GPVI (Glycoprotein VI) receptor. This receptor plays a role in thrombosis but only has minor ...
- Source: drugdu
- 112
- October 16, 2023
After Novo’s Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known. Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population. DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps. Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the ...
- Source: drugdu
- 135
- October 14, 2023
What to Expect

Ira Studin, PhD President Stellar Managed Care Consulting The old axiom, “The truth is somewhere in between” may be a useful lens to gauge how a new generation of obesity drugs will perform in the payer market. On one side is the school of thought suggesting that annual revenues will be in the multi-billions, with investment analysts’ tacitly assuming insurance will support demand. On the other side is the “PCSK9” school, referring to extreme barriers payers created to restrict Repatha and Praluent coverage as an alternative to statins. The discussion below will draw on conversations with payers and describe the likely payer market between these two sides. HEAVY DISCOUNT OR ELSE There is a through line from the cholesterol lowering drugs that put their stamp on the market starting in the 1990s and weight loss drugs today. Assuming Mounjaro follows Wegovy’s recently announced outcomes data, the parallel with statins centers ...
- Source: drugdu
- 185
- October 14, 2023
Novo Ends Semaglutide Kidney Study Early Due to Strong Efficacy Signals

By Tristan Manalac Novo Nordisk is ending its Phase III FLOW trial ahead of schedule after an interim analysis of the kidney outcomes study of semaglutide found a very high likelihood of study success, the company announced Tuesday. FLOW, a large randomized, double-blinded and placebo-controlled superiority trial, was assessing the effects of Novo’s GLP-1 agonist semaglutide on the progression of renal impairment and on the risk of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease (CKD). Semaglutide is the active ingredient in Novo’s diabetes drug Ozempic and weight-loss treatment Wegovy, approved in January 2020 and June 2021, respectively. The study enrolled more than 3,500 patients worldwide and administered semaglutide as an adjunct to standard of care. FLOW’s protocol allowed for an interim analysis once a specific and pre-determined number of primary endpoint events had already occurred. At this interim analysis, an independent Data Monitoring ...
- Source: drugdu
- 120
- October 13, 2023
FDA Blocks Alnylam’s Bid to Expand Onpattro Label

By Tristan Manalac Pictured: Alnylam headquarters in Cambridge, Massachusetts/iStock, hapabapa The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. In its Complete Response Letter (CRL), the regulator said that Alnylam had not provided enough evidence of the therapy’s benefit in the proposed indication. At the same time, the FDA did not flag any problems with patisiran’s clinical safety, drug quality, manufacturing processes or study conduct. “The CRL indicated that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis had not been established,” according to the company’s announcement. In light of the rejection, Alnylam will no long work toward an expanded label for Onpattro in the U.S. Monday’s CRL runs counter to the recommendations of the FDA’s own panel of external advisers. In September 2023, the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in ...
- Source: drugdu
- 108
- October 11, 2023
FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024. By FRANK VINLUAN An Alnylam Pharmaceuticals drug developed to treat a rare disease’s potentially fatal effects on the heart has fallen short in its bid for FDA approval, costing the company a chance to immediately challenge a Pfizer product that has become a blockbuster seller in the indication. But the biotech still has another chance with a different drug in late-stage development that could offer patients a better alternative. Alnylam was seeking approval of its drug, Onpattro, as a treatment for cardiomyopathy caused by hereditary transthyretin amyloidosis (hATTR). According to the Cambridge, Massachusetts-based company, the FDA’s complete response letter said ...
- Source: drugdu
- 217
- October 11, 2023

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