According to analysis, semaglutide reduced the composite risk of cardiovascular (CV) death or worsening heart failure (HF) events by 31%, with incidence rates of 5.4% in the semaglutide group and 7.5% in the placebo group (HR 0.69; 95% CI 0.53-0.89; P=0.0045). semaglutide also reduced the risk of HF worsening by 41% (2.8% vs. placebo 4.7%; HR 0.59 (95% CI 0.41-0.82), p=0.0019). Simeglutide had no significant effect on the incidence of CV mortality (3.1% in the Simeglutide group and 3.7% in the placebo group). Hr 0.82 (95% CI 0.57-1.16), p=0.25) The statistical analysis did not adjust for multiplicity, and the hazard ratio should not be used to infer definitive treatment efficacy. In the United States, semaglutide is not approved for use in heart failure. This study is a summary and post hoc participant level analysis of 3743 patients with a history of HFpEF from four randomized trials, aimed at examining the ...
MU Biotech Circle Recently, Eli Lilly announced plans to directly sell single dose vials of its weight loss drug Zepbound (tirzepatide) to consumers. The new prices for 2.5mg and 5.0mg doses are $99.75/vial and $137.25/vial, respectively, with corresponding monthly costs of $399 and $549, respectively, with a price reduction of over 50%. Novo Nordisk may adopt a similar strategy towards its Wegovy, with specific details to be revealed by its CEO during a Senate Health Committee hearing on September 24th. Analysts have responded positively to Eli Lilly’s move to lower Zepbound prices and offer the drug through its new self funded pharmacy component on its direct to consumer platform LillyDirect (launched in January this year). Joon Lee, an analyst at Truist Securities, believes that given the high demand for patients willing to purchase at their own expense, there is no reason why other GLP-1 manufacturers should not adopt similar strategies. ...
Eli Lilly and Company has announced the availability of Zepbound (tirzepatide) in 2.5mg and 5mg single-dose vials for self-pay for adults with obesity. The move significantly expands the supply of Zepbound in response to high demand and offers a more affordable option for those who self-pay. The vials are priced a minimum of 50% lower than the list price of other incretin medicines for obesity. Lilly has introduced a new self-pay pharmacy component within LillyDirect, enabling patients with a valid prescription to purchase Zepbound directly. The initiative ensures the authenticity of the medicine and safeguards patients from counterfeit products. Lilly also announced its commitment to ensuring that Zepbound is used appropriately and not for cosmetic weight loss, implementing a multi-step verification process for dispensing. The 2.5mg Zepbound vial costs $399 for a four-week supply while the 5mg dose costs $549 – both representing significant savings compared to other treatments. The ...
In a Phase 3 study, Eli Lilly’s tirzepatide led to a 94% reduction in the risk that obese or overweight prediabetes patients progress to type 2 diabetes. Lilly was already planning to expand use of the blockbuster metabolic disorders drug to sleep apnea and heart failure. By Frank Vinluan The longest clinical trial to date for a blockbuster Eli Lilly metabolic disorder drug now has data showing the treatment delayed progression to type 2 diabetes in patients who are obese or overweight, results that continue to build the case of broader health benefits for the therapy. The preliminary results announced Tuesday come from a clinical trial designed to test once-weekly injections of tirzepatide in prediabetes participants. In addition to being overweight or obese, participants also had at least one weight-related complication, excluding diabetes. The main goal of the placebo-controlled study is assessing tirzepatide’s effect on weight. At the highest of three ...
The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
Recent financing news includes several companies raising money to advance their research to the clinic. Here’s a look back at funding rounds from companies such as Outpace Bio, GRO Biosciences, and Confo Therapeutics. By Frank VinluanOne challenge for developing drugs for autoimmune diseases is that biologic therapies can spark an immune response against them. Immunology and inflammation research is coming up with new approaches to reduce the risk of such responses. That science is progressing in the hands of new companies raising fresh rounds of capital. Inflammation and immunology figures prominently in recent funding news, which includes several companies approaching the clinic with novel biologic drugs. Here’s a recap of recent biotech financings, grouped according to therapeutic area: Immunology & Inflammation —Abiologics unveiled an artificial intelligence-driven platform technology for designing novel biologic drugs based on non-standard amino acids. The startup, which has been incubating within Flagship Pioneering for the past ...
By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
Respiratory disease and immunology are the initial focus areas of GSK’s new drug discovery partnership with Flagship Pioneering. A similar Flagship alliance with Pfizer recently announced it is pursuing novel obesity treatments. By Frank VinluanGSK already has a strong presence in respiratory disease and immunology, two of its core therapeutic areas. The pharmaceutical giant is now teaming up with Flagship Pioneering in an alliance intended to discover novel medicines to bolster its pipelines in both disease categories. The deal announced Monday calls for the partners to fund up to $150 million up front for an exploration phase intended to identify concepts that can leverage the technologies of Flagship’s portfolio companies. Flagship forms and incubates startups, each one based on a platform technology that focuses on some aspect of biology. The research stemming from these platforms informs the discovery and development of novel medicines. The best known of these “bioplatform” companies ...
The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic small interfering RNA (siRNA) pipeline in clinical settings. The company will also use the investment proceeds to develop next-generation RNA platforms. LongRiver Investments spearheaded the financing round, which saw contributions from Zhaode Investment, Zhongqi Capital, BioTrack Capital and Lilly Asia Ventures. LongRiver Investments will become part of Rona’s board. The company focuses on developing siRNA programmes, with its first product, RN0191, having completed Phase I clinical studies in Australia and China. In December 2023, Rona received clinical trial application clearance from the National Medical Products Administration in China to assess RN0191 injection to treat hypercholesterolemia, mixed hyperlipidemia and atherosclerotic cardiovascular disease, to reduce the risk of cardiovascular events. The asset is set to enter Phase II clinical development for hypercholesterolemia. Rona’s second programme, RN0361, is scheduled to enter clinical trials in the second quarter of ...
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