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Amgen said Tuesday that that its drug, MariTide , led to an average of roughly 20% weight loss over a year in the Phase 2 study in participants who had obesity or who were overweight without type 2 diabetes.
Can Eli Lilly’s blockbuster obesity medicine lower the risk of diabetes? And will Recursion Pharma, the AI drugdeveloper, live up to all the hype? What does the hiring of a well-known industry dealmaker mean for the future of BioMarin Pharmaceuticals? ” Read the rest…
The Structure drug, called GSBR-1290, may have a tolerability advantage: Only one participant out of 36 dropped out of the study due to drug-related side effects — a 2.8% discontinuation rate that could prove to be an advantage if confirmed in larger studies. Continue to STAT+ to read the full story…
regulators in Europe on Friday recommended that the approval of Eli Lilly’s diabetesdrug Mounjaro be widened to include obesity. Doctors have been prescribing the diabetesdrugs off-label for obesity, but having specific authorization could streamline the process of getting the medicines.
government agency on Tuesday said that it won’t recommend Eli Lilly’s Mounjaro — part of a new class of medications that help patients lose weight — for people with type 2 diabetes without additional evidence. LONDON — A U.K. Mounjaro, also known as tirzepatide, has U.S.
The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, like mental health disorders , Alzheimer’s, and even, as new study results suggest — Parkinson’s disease.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, and congratulations on making it through another week. She is very likely the cutest and most relatable animal I’ve ever seen.
PHILADELPHIA – Novo Nordisk, which has dominated the diabetes and obesity markets with its blockbuster drugs Ozempic and Wegovy, now also wants to be a major player in heart disease. It’s also developing several treatments specific to heart disease and is acquiring a medication for high blood pressure.
Type 2 diabetes is the most common – it’s long been linked to obesity, and the latest GLP-1 treatments like Wegovy and Zepbound were initially developed as diabetesdrugs. But behind diabetes, the next most common disease under investigation for obesity candidates is MASH.
It’s also the latest attempt to deal with one of the biggest challenges in drugdevelopment: What should a company do when it wins big? But inventing a mega-blockbuster — in this case novel drugs that treat obesity and diabetes — brings its own set of issues. Victory is hardly defeat.
Nearly two decades ago, a small company called Amylin Pharmaceuticals saw that its first commercial product, a diabetes treatment targeting receptors of the amylin hormone, led to weight loss in early clinical trials. The company ultimately didn’t pursue an indication in weight loss. Continue to STAT+ to read the full story…
Her team had failed to wrestle a gut hormone called GLP-1 into a new kind of drug for diabetes. Thomsen got right to the point. Management was giving them one more shot. And by them, he meant her. “You need to figure out what to do with GLP-1,” he said. “And it has to be now.”
But when it comes to what is arguably the hottest space in drugdevelopment today — controlling weight and diabetes for millions of people worldwide — the brainy innovators from Kendall Square have missed out on the booming market, at least so far.
after four weeks in patients with obesity who did not have diabetes. The company said its once-daily pill, called CT-996, led to a placebo-adjusted average weight loss of 6.1%
And before the end of the month, Vertex will share results from a mid-stage trial in people with diabetes who have chronic nerve pain. The company will announce data early next year from Phase 3 studies testing the molecule’s effectiveness at treating post-surgical pain.
The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference. The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year.
billion deal in which Novo Nordisk’s parent foundation would acquire Catalent, a leading contract drug manufacturer, over concerns the acquisition will harm competition and reduce patient access to popular diabetes and weight loss medicines.
But Eli Lilly has been following close behind with new treatments, and after dropping result after result from successful trials at the American Diabetes Association conference here this past weekend, the Indianapolis-based drugmaker looks to be gaining an edge over its Danish competitor in the race to supply obesity drugs.
Also, the agency’s advisers debate Guardant’s colon cancer liquid biopsy test, and we see new data showing Ozempic’s efficacy in preventing death in diabetes and chronic kidney disease patients. Read the rest…
With the immense demand for GLP-1-based drugs and recurring shortages of the branded treatments, a wide variety of businesses have popped up to offer their own versions of what they claim are GLP-1 drugs. No other company has bid on the contract — to supply 14 million pens for the next three years, at about $2 per pen. The
Enjoy, and see you soon… Western drug makers are talking to alternative suppliers in response to draft U.S. legislation seeking to restrict an important Chinese drugdeveloper and manufacturer over national security concerns , The Financial Times explains. But be safe. The Biosecure Act would prohibit U.S.
On top of today’s Alnylam news, we have Congress gearing up to vote on Medicare coverage for multi-cancer screenings and obesity drug coverage. Also, updates on Vertex’s type 1 diabetes cell therapy, and a push for phage therapy. Read the rest…
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drugdevelopment. This team will focus on creating a versatile computational platform that can precisely forecast the first-in-class drug candidates’ efficacy in virtual patient groups.
During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drugdevelopment. What are the trends affecting drugdevelopment today?
Among 98 patients with nonalcoholic fatty liver disease, those on the highest dose tested of the drug, retatrutide, experienced an 86% decrease in liver fat over 48 weeks, with most of the reduction occurring early on in treatment, according to data presented here at the American Diabetes Association conference Monday.
The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. Novo Nordisk is leading the pack with four separate products, two apiece in Phase III and Phase II.
Obesity, diabetes, and genetics are the primary drivers, and COVID is about to make this exponentially worse. Dozens of companies are working at various stages of drugdevelopment. The post Fatty liver disease: With little early detection, more challenging drugdevelopment appeared first on. About the Author.
The plan is to increase investment in its drug-development pipeline and cut costs, and the split could take place as early as the fourth quarter of 2024. The panel committee reviewed non-clinical, clinical, and post-marketing data of the drugs, and said that no updates to their prescribing information was required at the time.
Food and Drug Administration did not find evidence that GLP-1 drugs like Ozempic and Wegovy cause suicidal thoughts or actions , STAT notes. Novartis backed away from its pursuit of Cytokinetics, putting a damper on the prospects of a deal for the promising heart-drugdeveloper , The Wall Street Journal reports.
A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus. Novo Nordisk said it plans to submit oral semaglutide for U.S. approvals later this year. Continue to STAT+ to read the full story…
(LAI-287 + semaglutide) is under clinical development by Novo Nordisk and currently in Phase III for Type 2 Diabetes. According to GlobalData, Phase III drugs for Type 2 Diabetes have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.
Patients on insulin fear the GLP-1 gold rush is leaving them behind As Novo Nordisk and Eli Lilly invest billions to scale up manufacturing capacity for their highly profitable GLP-1 drugs, diabetes patients around the world are suddenly facing shortages of various insulin products. Read the rest…
Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans , STAT explains. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.
Shots: With an incurable nature and hefty medication costs, diabetes mellitus remains a global health concern and the seventh leading cause of death across the world. Diabetes, aka diabetes mellitus is a condition that arises when the pancreas fails to produce enough insulin or the cells of the body do not respond to the insulin produced.
Momna Ali, Healthcare Analyst at GlobalData, states, “Amylyx’s acquisition of avexitide marks its entry into the drugdevelopment field for metabolic diseases, a departure from its prior focus on neurodegenerative diseases. This shift in strategy comes after Relyvrio’s disappointing efficacy results from the drug’s confirmatory trial.
As a pharmacy educator, I love the history of drugdevelopment for instance, and in every discussion, I have with students, whether in the classroom or small groups, I like to frame our current understanding of what we are doing based on what we used to do. Take for example Type I Diabetes (sometimes called Juvenile Diabetes).
The drug, developed by Incyte and licenced to Lilly, is also used to treat rheumatoid arthritis. US-based Eli Lilly’s baricitinib (Olumiant), a Janus kinase inhibitor, and GlaxoSmithKline and Vir Biotechnology’s sotrovimab, a monoclonal antibody, were recommended in new WHO guidelines, published in the British Medical Journal. .
Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of DrugDevelopment for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.
Rising demand for affordable and accessible drugs in regions like Asia-Pacific, Latin America, and Africa can offer potential for manufacturers in this sector to become established in these markets and work on their drugdevelopment. This opportunity can lead to higher production and revenue, the research reported.
Positive results from the long-term follow-up of a Phase II study of small molecule inhibitor UBX1325 in patients with diabetic macular edema (DME) have been announced. The long-term data from the clinical trial demonstrate “a remarkable result,” according to Anirvan Ghosh, PhD, Chief Executive Officer of UNITY.
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