Sitagliptin

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars

a month ago

• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition. • Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition. • The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.

Ozempic Significantly Improves Walking Distance in Patients with Type 2 Diabetes and Peripheral Artery Disease

2 months ago

• Phase 3 STRIDE trial results show Ozempic (semaglutide) 1 mg increased maximum walking distance by 13% compared to placebo in patients with type 2 diabetes and peripheral artery disease. • Patients treated with semaglutide experienced a clinically meaningful median improvement of 26.4 meters in walking distance on a 12% incline, along with better pain-free walking and quality of life measures. • Based on these positive findings, Novo Nordisk has submitted a label extension application to the FDA, potentially making Ozempic the first new medication in over two decades to improve functional outcomes in PAD patients.

Pharmaceutical Industry Braces for $236 Billion Patent Cliff by 2030: Strategic Responses from Major Players

3 months ago

• The global pharmaceutical industry faces a $236 billion patent cliff between 2025-2030, with nearly 70 blockbuster drugs losing exclusivity and exposing major companies to significant revenue losses. • Key drugs approaching patent expiration include Merck's Keytruda ($25B), Bristol-Myers Squibb's Eliquis ($12B), and Johnson & Johnson's Stelara ($10.9B), forcing companies to rapidly adapt through pipeline diversification and cost-cutting measures. • Companies are responding with increased M&A activity, AI-driven R&D efficiency, and strategic pivots to high-growth therapeutic areas, while the cliff will likely improve drug affordability but potentially slow innovation.

FDA Approves First Generic Rivaroxaban 2.5mg for Cardiovascular and Peripheral Artery Disease Prevention

3 months ago

• The FDA has approved the first generic version of Xarelto (rivaroxaban) 2.5mg tablets for reducing major cardiovascular events in coronary artery disease patients and thrombotic events in peripheral artery disease patients. • The approval marks a significant milestone in expanding access to anticoagulant medications, as blood thinners are among the most frequently prescribed drugs in the United States. • This generic approval aligns with FDA's commitment to providing more affordable treatment options while maintaining safety and efficacy standards for cardiovascular disease management.

Merck and Pfizer Launch Competitively Priced SGLT2 Inhibitor Steglatro for Type 2 Diabetes

4 months ago

• FDA approves Steglatro (ertugliflozin) and its combination therapies Steglujan and Segluromet for type 2 diabetes management, expanding treatment options in the SGLT2 inhibitor class. • Merck and Pfizer strategically price Steglatro at $8.94 per day, significantly lower than competitors Farxiga ($11.57) and Jardiance ($13+), aiming to gain market share. • Cardiovascular outcomes data from the 8,000-patient Vertis CV Study is expected by October 2019, which could impact the drug's competitive position in the market.

Merck Cuts Diabetes Drug Price Amid New Year Price Hikes

5 months ago

Merck has reduced the price of its diabetes drug Januvia by 42%, diverging from the trend of drug price increases at the start of the year. This decision is influenced by changes in the Medicaid rebate program and aims to align list prices more closely with net prices for patient benefit. Meanwhile, Neumora Therapeutics faces a setback as its experimental depression drug fails in a Phase 3 study, highlighting the challenges in developing new antidepressants.

FDA Rejects Sotagliflozin for Type 1 Diabetes with CKD Following Negative Advisory Review

5 months ago

Lexicon Pharmaceuticals announced that the FDA has rejected sotagliflozin (Zynquista) as an adjunct to insulin therapy for type 1 diabetes patients with chronic kidney disease. The decision follows a negative FDA advisory committee review in October, marking a setback in treatment options for this specific patient population.

Merck Enters Obesity Market with $112M Deal for Hansoh's Oral GLP-1 Drug

5 months ago

• Merck & Co. has secured global rights outside China to Hansoh Pharma's preclinical oral GLP-1 receptor agonist for obesity treatment through a $112 million upfront payment. • The deal includes potential milestone payments up to $1.9 billion, with Hansoh retaining options for commercialization in China, marking Merck's strategic entry into the competitive obesity drug market. • This licensing agreement represents Merck's first major move into obesity therapeutics, following the company's successful track record with diabetes drug Januvia and expanding beyond its cardiovascular portfolio.

Medicare's First Drug Price Negotiations Yield Mixed Results: U.S. Prices Still Exceed International Levels

6 months ago

• Medicare's first round of drug price negotiations achieved reductions ranging from 8% to 42% across ten medications, with sitagliptin showing the most significant price decrease. • Despite negotiated reductions, nine out of ten drugs remain more expensive in the U.S. compared to six other high-income countries, with only insulin aspart reaching international price levels. • Analysis reveals strategic pricing patterns, with biologics like etanercept, ibrutinib, and ustekinumab seeing 33-40% reductions, while negotiations appeared to align drug prices with therapeutic value.

Medicare Names First 10 Drugs for Price Negotiations, Including Major Diabetes and Cancer Therapies

2 years ago

• The Department of Health and Human Services has identified 10 widely-used medications for Medicare's first-ever drug price negotiations, collectively accounting for $50 billion in annual Medicare spending. • Johnson & Johnson faces significant impact with three medications on the list - Imbruvica, Stelara, and Xarelto - while other affected drugs include popular treatments from Bristol-Myers Squibb, Pfizer, Novartis, and AstraZeneca. • The negotiated prices will take effect January 2026, though multiple pharmaceutical companies have filed lawsuits challenging the program's constitutionality under the Inflation Reduction Act.

Drug Development Updates