By Tristan Manalac Pictured: Pfizer sign on building/Tobias Arhelger/Adobe Stock Pfizer is discontinuing the clinical development of its investigational GLP-1 receptor agonist lotiglipron, which was being developed for obesity and Type 2 diabetes mellitus, the company announced Monday. The decision to cut lotiglipron from Pfizer’s pipeline comes after the company detected heightened concentrations of liver transaminases in patients treated with the investigational drug. Lotiglipron was being evaluated in two Phase I drug-drug interaction studies and one Phase II trial. Pharmacokinetic data from the two Phase I studies also contributed to the candidate’s discontinuation. None of the patients developed liver-related symptoms or similar side effects and neither required medical intervention. Pfizer also did not document signs of liver failure among these patients. The company will present lotiglipron data at an upcoming conference or will submit it for publication in peer-reviewed journals. With lotiglipron’s discontinuation, Pfizer will instead focus on the clinical ...
Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill. The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American ...
Chronic kidney disease (CKD) affects around 37 million Americans, but this disease, which does not get the attention other conditions often do, can go undetected for years, boosting the risks of organ failure and even death.AstraZeneca, maker of blockbuster diabetes drug Farxiga that recently nabbed an expanded label in CKD, wants more to be done to find those who have this disease. The pharma cited new, real-world evidence that shows the prevalence of undiagnosed stage 3—moderate—CKD is 85% to 97% across Australia, Brazil, Canada and Spain. The study was shared this month at the European Renal Association 2023 Congress in Milan, Italy. This is a “staggeringly low rate” of diagnosis in CKD, according to an accompanying release from AstraZeneca, with these data showing “that an urgent need exists for improved screening.” Improved screening can lead to earlier diagnosis and thus potentially better outcomes, given that once kidney damage sets in ...
Contract research organisation IRBM has announced an extension to its collaboration with US-based Merck & Co. (MSD) to develop peptide therapeutics. IRBM began as part of MSD, in 2000, before being spun off in 2010. Following the separation, the companies continued to work together on drug discovery, with the collaboration being expanded in 2020 to develop peptide therapeutics for coronavirus. Advances in phage and mRNA display platforms have accelerated peptide development in recent years. In particular, IRBM claims it has made major progress with half-life extension strategies and utilising formulation enhancers to support oral route administrations. IRBM told Pharmaceutical Technology that AI is beginning to play a part in peptide discovery, and that radiotheranostics was a rapidly growing area of interest. Italy-based IRBM draws upon expertise in peptide drug development to bring new candidates to fruition. It utilises a platform that covers the entire range of activities required to discover ...
The Saudi Food and Drug Authority (SFDA) has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular (CV) risk. VASCEPA is indicated as an adjunct to statin therapy for use in adult patients with elevated levels of triglycerides (TG). This means levels greater than or equal to 150 mg/dL. It has also been approved for use in patients at increased risk of CV events caused by at least one other CV disease risk factor and established CV disease, or who have diabetes mellitus. The therapy is the first and only medicine to receive approval from the regulator to reduce CV risk beyond cholesterol-lowering therapy in patients on high-risk statin treatment and who have increased TG levels. Amarin stated that the country’s National Heart Center (NHC) and the Saudi National Diabetes Center (SNDC) have mentioned icosapent ethyl (IPE) as an adjunct to statin therapy for CV risk reduction in ...
By being undiagnosed or untreated, a significant fraction of people with obesity or overweight are not getting the recommended care, despite an increase in new treatment options, according to research being presented on June 17 at ENDO 2023, the Endocrine Society’s annual meeting in Chicago, Ill. “The number of people with obesity is high and rising in the adult U.S. population. Obesity is a complex and expensive disease that has been implicated in many chronic conditions including high blood pressure, diabetes, and cardiovascular diseases,” said Kyrian Ezendu, Ph.D., an Eli Lilly and Company advisor on benefit-risk research. “Medications to treat obesity are an integral part of long-term care for people with excess weight and are recommended for people with obesity or people with overweight and at least one obesity-related condition.” Ezendu and colleagues used data from linked electronic health records and insurance claims of people ages 18 to 80 years ...
Merck & Co – known as MSD outside the US and Canada – has said its investigational GLP-1/glucagon receptor co-agonist, efinopegdutide (MK-6024), has demonstrated promising results in nonalcoholic fatty liver disease (NAFLD). NAFLD is a chronic and progressive condition in which fat builds up in the liver. It is known as a silent disease with few or no symptoms, however, certain health conditions such as obesity, metabolic syndrome and type 2 diabetes, increase the likelihood of developing NAFLD. There is not currently any approved medicine that can treat NAFLD, with treatment options focused on managing the problems associated with the condition. The findings, which will be presented at the European Association for the Study of the Liver (EASL) annual congress, include new data from a phase 2a randomised, open-label study evaluating the compound’s efficacy in liver fat reduction and safety against Novo Nordisk’s semaglutide in NAFLD patients. The candidate was ...
Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
Researchers at the Faculty of Medicine at the University of Freiburg have gained significant new insights into metabolic processes in the kidney. The scientists from the Institute of Genetic Epidemiology at the Medical Center – University of Freiburg measured tiny molecules, so-called metabolites, which occur in blood and urine and reflect our metabolism, in samples from more than 5,000 study participants. They compared these with the genome of the test persons and were able to identify 1,299 genetic changes that are associated with metabolites and contribute to their production, degradation or transport. The findings provide a better understanding of processes throughout the body and particularly in the kidney, which produces urine from blood plasma. These discoveries, which appeared June 5, 2023, in the journal Nature Genetics, could lead to a better understanding of diseases and new approaches to their treatment. For example, a new class of therapies for treating diabetes, ...
By Deidre McPhillips, CNN More than a third of adults in the US take at least three prescription medications and many are rationing them, according to a new CDC report. Owaki/Kulla/The Image Bank RF/Getty Images/FILE CNN — Millions of adults in the United States are not taking their medications as prescribed because of costs, according to a new report from the US Centers for Disease Control and Prevention. Most adults between the ages of 18 and 64 took at least one prescription medication in 2021. But more than 8% of them – about 9.2 million people – said they tried to save money by skipping doses, taking less than prescribed or delaying a prescription fill, according to the CDC data. Although average drug costs did not increase in 2021, the number of prescriptions did, and that raised spending. More than a third of adults took at least three prescription medications ...
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