The European Medicines Agency has identified risks of self-harm and suicidal ideation that could potentially be linked to Novo Nordisk’s medications containing the active ingredients semaglutide and liraglutide. The potential risks were first identified by the Icelandic Medicines Agency, according to a CNN report, citing the EMA. Iceland’s regulator documented one case of suicidal ideation in a patient who had taken the diabetes drug Ozempic (semaglutide) and another after using the weight-loss medicine Saxenda (liraglutide). A third incident involving thoughts of self-harm was also detected in a patient who was receiving Saxenda. The Pharmacovigilance Risk Assessment Committee (PRAC), the EMA’s main group responsible for assessing and monitoring the safety of drug products, has put both treatments under review. The committee is also evaluating whether it will need to extend the review to other products in this drug class, according to CNN. This class, called GLP-1 receptor agonists, include Novo’s Wegovy, Victoza, and Rybelsus, as well as ...
Pictured: Novo Nordisk building in California/iStock, hapabapa Thursday, Novo Nordisk filed legal complaints against three pharmacies in Florida and one in Tennessee for allegedly selling products that contain semaglutide, the active compound in the company’s best-selling weight-loss and diabetes drugs Ozempic, Wegovy and Rybelsus, Bloomberg reported. Novo filed three separate lawsuits in Florida federal court, targeting three compounding pharmacies: WellHealth, TruLife Pharmacy and Brooksville Pharmaceuticals. A fourth lawsuit was filed in Tennessee against DCA Pharmacy. The Danish drugmaker is asking the courts to block these pharmacies from marketing their semaglutide-containing products and is seeking unspecified financial damages. This latest round of lawsuits comes two weeks after Novo sent out a barrage of legal complaints against wellness and weight loss clinics, medical spas and other compounding pharmacies, also claiming that these businesses were selling products containing semaglutide. Semaglutide is a peptide that mimics the GLP-1 hormone to active its counterpart receptor. In turn, this induces the pancreas to secrete ...
Zealand Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its treatment dasiglucagon for use in paediatric patients aged seven days or older with congenital hyperinsulinism (CHI). Based on an announcement released on 30 June, the application is based on clinical data from two Phase III studies and interim results from an ongoing long-term extension trial (NCT03941236). This includes results from a Phase III trial (NCT041724412), which tested dasiglucagon’s efficacy and safety in a hospital setting among 12 neonates and infants with CHI aged seven days to 12 months. In the first part of the trial, which took the form of a 48-hour crossover study, dasiglucagon reduced the need for glucose infusions by 55%. The application also features data from a second Phase III study (NCT03777176), which tested subcutaneous dasiglucagon infusions in 32 children with CHI aged three months to 12 years. ...
The US Food and Drug Administration (FDA) has approved CellTrans’ Lantidra (donislecel) as the first cellular therapy to treat patients with type 1 diabetes. The authorisation specifically applies to adults who are unable to meet their target blood glucose levels because they have repeated episodes of severe low blood sugar (hypoglycaemia), despite intensive disease management and education. Almost 1.9 million people in the US have type 1 diabetes, according to the American Diabetes Association. The condition requires lifelong care, including the regular administration of insulin, either through multiple daily injections or continuous infusion using a pump. However, some patients have trouble managing the amount of insulin needed every day, and dosing becomes difficult. These patients may also develop hypoglycaemia unawareness, where they are unable to detect that their blood glucose is dropping and may not have a chance to treat themselves. Lantidra, which is administered initially as a single infusion, ...
The US Food and Drug Administration (FDA) has announced that Lantidra, a cellular therapy for type 1 diabetes (T1D), has become the first treatment of its kind to be approved. Lantidra is an allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells. The approval applies to adults with ‘brittle’ T1D – those unable to reach target glycated haemoglobin (average blood glucose levels) due to repeated severe hypoglycaemic episodes, despite intensive diabetes management and education. T1D accounts for roughly 5%-10% of all diabetes cases. Within this population, an even smaller group, approximately three out of every 1,000 people with T1D, suffer from ‘brittle’ disease. The therapy works by essentially replacing the body’s insulin-producing beta cells in the pancreas. This is achieved through allogeneic islet beta cells that secrete insulin, administered as a single infusion into the hepatic (liver) portal vein. While this is generally sufficient, an additional infusion ...
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 ...
Dive Brief More than 1.31 billion people worldwide could be living with diabetes by 2050, according to estimates published in the Lancet. In 2021, roughly 529 million people worldwide had diabetes, according to the International Diabetes Federation. The rise in prevalence is expected to be driven by increases in Type 2 diabetes. Overall healthcare spending related to diabetes is expected to rise to $1.054 trillion by 2045, the authors wrote. Global spending in 2021 was estimated at $966 billion by the International Diabetes Federation. Dive Insight With diabetes cases expected to increase globally, current treatment is focused on biomedical interventions and new devices, according to an editorial published in the Lancet that accompanied the researchers’ findings. The authors said people who are marginalized and discriminated against suffer the “most and worst consequences” of diabetes, and “addressing structural racism must become a core component of preventive strategies and health promotion — ...
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 ...
Dive Brief U.S. consumers doubled their use of wearable healthcare devices, including smartwatches, wearable monitors and fitness trackers, between 2020 and 2021, according to a new survey from AnalyticsIQ. Among wearable monitors, blood pressure devices were the most popular, used by 59% of survey respondents, followed by sleep monitors (21%) and ECG monitors (11%). Biosensors such as glucose monitors, hormone monitors, fall detectors and respiratory monitors were used by 8% of consumers in the survey, followed by use of smart clothing items at 6%. The wearable biosensors niche alone grew from $150 million globally in 2016 to $25 billion in 2021, the data analytics firm said. Dive Insight The use and variety of consumer health technology devices has increased dramatically over the past two decades. Scientists at AnalyticsIQ developed a survey to find out how people are incorporating health tech into their lives, asking about 8,000 Americans across the country ...
Over 37 million Americans have diabetes, and 90-95% of that population are diagnosed with type 2 diabetes. Lifestyle interventions, such as a healthy diet and a regular physical activity program, are methods to manage diabetes. A new study from a collaboration of investigators at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, and Joslin Diabetes Center, part of Beth Israel Lahey Health, uses data from the Look AHEAD (Action for Health in Diabetes) study, a randomized controlled trial that compared an intensive lifestyle intervention with diabetes support and education in patients diagnosed with type 2 diabetes and overweight or obesity to track the development of cardiovascular disease over time. In the current study, the research team assessed whether physical activity at certain times of day was associated with greater improvement in blood glucose control. Their findings suggest patients with type 2 diabetes who were ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.