Eli Lilly (NYSE:LLY) announced positive results from a trial comparing tirzepatide to titrated insulin glargine in adults with type 2 diabetes.
Indianapolis-based Eli Lilly’s Surpass-4 clinical trial demonstrated that adults with type 2 diabetes and increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine.
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Eli Lilly (NYSE:LLY) has announced that it has approved Verzenio (abemaciclib) for certain patients with HR+ HER2– high-risk early breast cancer.
The drug will become the first inhibitor of cyclin-dependent kinase 4 and 6 (CDK4/6) to hit the U.S. market.
“Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, president of Lilly Oncology, in a statement.
The twice-daily therapy Verzenio will be available in tablet forms at 50, 100, 150 and 200-mg dose levels.
Indianapolis–based Lilly noted that the FDA approval covered the use of the drug in tandem with endocrine therapy such as tamoxifen or an aromatase inhibitor.
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Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.
The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.
The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offer…
Eli Lilly and Company (NYSE: LLY) has announced its plan to issue €600 million in aggregate principal in the amount of 0.50% notes with 12-year maturity as part of its Environmental, Social and Governance (ESG) strategy.
In May, the company announced that it had updated its Environmental, Social and Governance (ESG) strategy, bolstering its investment in sustainability. The ESG strategy is based on five pillars outlined in its Sustainability Bond Framework. Those pillars including increasing access to medicines, improving lives and communities, empowering a diverse workforce, minimizing environmental impact, and operating ethically and responsibly.
“Lilly is taking another step forward in advancing our purpose of making life better for people around the world,” said Anat Ashkenazi, Lilly’s CFO, in a statement. “This sustainability bond is Lilly’s latest commitment to our ESG strategy, which is core to our mission.”
Ash…
Eli Lilly (NYSE:LLY) announced today that it will commit nearly $1 million over the next three years toward helping children with type 1 diabetes.
Indianapolis-based Eli Lilly, in a joint effort with the Leona M. and Harry B. Helmsley Charitable Trust, seeks to promote greater access to care and resources while inspiring confidence for children living with Type 1 diabetes through the Type 1 Diabetes Camps Initiative.
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After a slight hiccup disrupted weeks of improvement, the medtech industry again flexed its muscles over the last seven days.
MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 20) at 119.63 points, representing a 1.5% rise from the 117.92-point tally set a week prior.
The shift marks a quick rebound from the -1.2% dip observed in the previous week and the index now sits at its highest week-ending mark ever, having actually hit an all-time best of 119.72 points on Aug. 17.
Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 29.6% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling an 92.5% asc…
Eli Lilly (NYSE:LLY) today announced executive leadership changes as it creates neuroscience and immunology business units.
Indianapolis-based Eli Lilly split its bio-medicines segment into Lilly Neuroscience and Lilly Immunology in the organizational shift, to be made effective Sep. 5, with Anne White set to lead the neuroscience unit and Patrik Jonsson set to head up the immunology arm.
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Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its Lyumjev rapid-acting insulin.
Indianapolis-based Eli Lilly’s Lyumjev (insulin lispro-aabc injection) 100 units/mL holds indication to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
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Photo by Myriam Zilles on Unsplash
The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to make its selections.
The organization will announce final winers in the competition at ceremony in New York City on October 28, 2021.
In terms of pharmaceutical agents, the organization selected the following 34 nominees:
Company Drug nameAbbVie Inc.
Rinvoq (upadacitinib)
Adlon Therapeutics L.P., a subsidiary of Purdue Pharma
Adhansia XR (methylp…
The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now.
MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception.
Remarkably, the industry’s July 9 tally of 114.79 points a week prior had, at that point, been known to be the index’s all-time best to date. The new high set on Friday of last week totals an increase of 31.09 points.
Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too, especially after this latest unpredictable rise. The industry has registered a 58% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus it has fully eclipsed 100% growth from the mid-pand…
FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.
But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.
Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.
Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.
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Eli Lilly (NYSE:LLY) is looking for nominations for its inaugural Leonard Award series, which highlights advances in diabetes management. The company will select five winners and donate $100,00 to the non-profit Life for a Child, which provides medicines and supplies to children and youth with type 1 diabetes in developing countries.
Lilly is launching the award program to commemorate the 100th anniversary of the discovery of insulin in 1921. Sir Frederick G. Banting, Charles H. Best and J.J.R. Macleod at the University of Toronto discovered the hormone in 1921. James B. Collip later purified it, giving rise to the first use of insulin to treat diabetes on January 11, 1922.
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