Dapagliflozin

The Inflation Reduction Act gave CMS power to negotiate drug prices, but Public Citizen warns of patent abuses and evergreening tactics by manufacturers, costing Medicare billions in potential savings.

The Inflation Reduction Act allows CMS to negotiate Medicare drug prices, exposing patent abuses like evergreening. Four of 10 drugs would have faced competition, saving Medicare $4.9-$5.4B. Nine drugs show evidence of anticompetitive patent practices, delaying affordable alternatives. CMS must consider these practices to ensure fair prices for Medicare beneficiaries.

Negotiated prices for 10 Medicare drugs fell from initial net prices, with reductions ranging from 8% to 42%, but all except insulin aspart remained more expensive in the U.S. than in peer countries. The study highlights the need for continued assessment of future negotiation rounds, especially with potential inclusion of Part B drugs, to maximize savings.

Hunters at risk for heart attack/stroke due to physical exertion and colder temperatures. Positive results for sotatercept in pulmonary arterial hypertension. Fixed-dose combination of obicetrapib and ezetimibe nearly halved LDL cholesterol in statin-resistant patients. TAVR tradeoffs in permanent pacemaker rates and patient-prosthesis mismatch. Better outcomes with Sapien 3 Ultra Resilia TAVR valve. Michigan cardiologist sues for whistleblower retaliation. Machine learning algorithm RF-SLAM predicts mortality and heart failure hospitalization. Dapagliflozin reduces new-onset diabetes in cardiovascular/kidney disease patients. SGLT2 inhibitors improve outcomes in hypertrophic cardiomyopathy with diabetes. GLP-1 receptor agonists show kidney and cardiovascular benefits. Cilostazol reduces in-stent restenosis risk. Bartonella quintana infection risk in solid-organ transplant recipients. Donor-specific antibodies and allograft dysfunction linked to poor prognosis in heart transplant recipients. Regenerative capacity of human cardiomyocytes minimal in heart failure unless on left ventricle support device therapy.

SUMMIT trial shows tirzepatide reduces cardiovascular death or worsening heart failure events in obese HFpEF patients, with significant improvements in quality of life, functional capacity, weight, and systemic inflammation. Tirzepatide's benefits are consistent across subgroups, though the mechanism of its HF benefit remains unclear.

Maryland's Prescription Drug Affordability Board (PDAB) is set to cap payments for certain high-cost drugs, with a focus on six specific medications. AARP Maryland praised the decision, emphasizing the need for affordability, and urged broader application to all Marylanders.

Weight-loss drugs like Ozempic and SGLT2 medications reduce stroke survivors' risk of death and heart attack by 74% and 84% respectively, and lower second stroke risk by 67%.

Novo Nordisk's Rybelsus reduced heart attack, stroke, and cardiovascular death risk by 14% in a Phase 3 trial involving people with diabetes and heart/kidney disease. Novo plans to seek FDA approval for Rybelsus to protect heart health in diabetics by end of 2024, positioning it alongside Jardiance and Farxiga. Rybelsus, an oral semaglutide, also shows potential in weight loss, though Novo has not yet filed for obesity approval.

AstraZeneca's Farxiga, initially approved for type 2 diabetes, has exceeded $6 billion in sales and is projected to reach $7.4 billion next year. Success factors include addressing unmet needs, clear value propositions, and strategic market access. Farxiga expanded its indications to chronic kidney disease and heart failure, driving sales. Keytruda exemplifies a blockbuster drug with multiple indications. Market access strategies and pricing considerations are crucial for drug commercialization. The definition of a blockbuster is evolving, focusing on high-value drugs that justify R&D investments.

The drug and biotech industry thrives on M&A, new drug launches, and pipeline successes, with obesity drugs from Novo Nordisk and Eli Lilly leading. Large drugmakers like Eli Lilly, AstraZeneca, Pfizer, Sanofi, and Bayer are profitable and innovative, focusing on areas like weight loss, inflammation, and Alzheimer’s. Despite headwinds such as pipeline setbacks and macroeconomic uncertainty, investment in drug/biotech stocks has surged. The Zacks Large Cap Pharmaceuticals industry ranks in the top 19% of Zacks industries, outperforming the Zacks Medical Sector but slightly underperforming the S&P 500.