Search Results for “diabetes” – Page 34 – media

EMA Concern Stirs over Suicide Risk with Weight Loss GLP-1RA Drugs

The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm. The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes. The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts. Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide. GLP-1RAs are a rapidly growing ...
- Source: drugdu
- 107
- July 14, 2023
UAE, Saudi Arabia Serve as Gateway to International Markets for Biopharma

Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
- Source: drugdu
- 151
- July 13, 2023
EMA Flags Potential Suicide Risk Tied to Novo’s Ozempic, Saxenda

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 ...
- Source: drugdu
- 137
- July 13, 2023
Medtronic Secures Medicare Coverage for MiniMed 780G Insulin Pump

Dive Brief Medtronic has received Medicare and Medicare Advantage coverage for its recently approved MiniMed 780G insulin pump. The company said on Thursday that it has begun processing orders and will start shipping devices to patients with Type 1 diabetes who meet the eligibility criteria over “the next few weeks.” The coverage clears a barrier to patient access for a pump that is central to Medtronic’s plans to kickstart growth at its diabetes business after a tough period defined by regulatory problems. Dive Insight The U.S. Food and Drug Administration approved the 780G pump in April. Medtronic had aimed to bring the device to the U.S. market sooner, but its plans were delayed by a warning letter, hindering its ability to compete with Insulet and Tandem Diabetes Care in the insulin pump market. With the device now approved for use, Medtronic is working to ensure patients ...
- Source: drugdu
- 142
- July 13, 2023
Novartis Plans Appeal to Ward Off Entresto Generics

Swiss-based Novartis announced that the US District Court for the District of Delaware has invalidated the patent covering its cardiac drug Entresto, which expires on 15 July 2025 with the associated paediatric exclusivity. The company said it will now appeal to the US Court of Appeals for the Federal Circuit (CAFC) to further pursue the efforts to validate the combination patent around Entresto. A combination of sacubitril and valsartan, Entresto was first approved by the US Food and Drug Administration (FDA) to treat heart failure with reduced ejection fraction in July 2015. It is also approved to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients. Apart from the patent which was adjudicated by the District Court, additional patents for the combinations of sacubitril and valsartan, including the drug forms and dosages, are listed to expire from November 2026 to May 2036. ...
- Source: drugdu
- 260
- July 12, 2023
Novo Nordisk Files Another Round of Lawsuits Over Semaglutide Copycats

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 ...
- Source: drugdu
- 144
- July 11, 2023
Novo Nordisk Brings New Round of Lawsuits Against Compounded Versions of Ozempic and Wegovy

As demand skyrockets for GLP-1 drugs that can trigger significant weight loss, unauthorized versions of the treatments have started to fill pharmacies. In late May, the FDA warned of illegal knockoffs of Novo Nordisk’s Ozempic and Wegovy. Now, five weeks later, the Danish company has filed its second wave of lawsuits against pharmacies in the U.S. that are producing the copycats. Thursday, in federal courts in Florida and Tennessee, the company accused four companies of making compounded versions of its products that are not approved by the FDA. “Testing new drugs and obtaining the regularly acquired regulatory approval to sell them are time-consuming and very costly,” Novo said in its complaints. “Ignoring drug-approval requirements provides defendant an unfair competitive advantage over pharmaceutical manufacturers like Novo Nordisk. Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.” The defendants are compounding ...
- Source: drugdu
- 129
- July 11, 2023
Safety Concerns About New Weight Loss Drugs Brew as Demand Soars

By Heather McKenzie Pictured: Physician with notepad/iStock, Everyday better to do everything you love The European Medicines Agency recently flagged a safety signal regarding the potential for glucagon-like peptide-1 receptor agonists to cause thyroid cancer. The documentation—the first step taken by the regulator toward investigation of potential adverse events in approved products—comes as demand for the popular diabetes and weight loss drugs reaches a fever pitch. The safety signal reported by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in April covers a range of glucagon-like peptide-1 receptor (GLP-1) agonists, including semaglutide, the key ingredient in Novo Nordisk’s Wegovy, Ozempic and Rybelsus. Supplemental information was also requested from Eli Lilly, Sanofi and AstraZeneca, all of which manufacture drugs in this class. GLP-1 is a hormone that stimulates insulin secretion after eating, enabling a feeling of fullness and regulating blood sugar. GLP-1 agonists mimic the effects of this hormone, making them an ...
- Source: drugdu
- 112
- July 9, 2023
Light or moderate alcohol consumption does not protect against endocrine conditions

People who have just one or two drinks per day are not protected against endocrine conditions such as obesity and type 2 diabetes, according to a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism. Alcohol consumption is a significant public health concern because it is related to many medical conditions such as diabetes, obesity, liver conditions and heart disease. While it is widely accepted that excessive alcohol consumption causes a wide range of health issues, whether modest alcohol consumption has beneficial health effects remains controversial. Tianyuan Lu, (Ph.D., McGill University in Québec, Canada) said, “Some research has indicated that moderate drinkers may be less likely to develop obesity or diabetes compared to non-drinkers and heavy drinkers. However, our study shows that even light-to-moderate alcohol consumption (no more than one standard drink per day) does not protect against obesity and type 2 diabetes in the general ...
- Source: drugdu
- 112
- June 29, 2023
Eli Lilly experimental obesity drug helped patients lose up to 24% of their weight, study says

Eli Lilly’s experimental drug helped patients lose up to 24% of their weight after almost a year, the highest reduction seen in the obesity treatment space to date, according to new mid-stage clinical trial results released Monday. The phase two trial followed 338 adults who were obese or overweight and either received the pharmaceutical company’s injection, retatrutide, or a placebo each week. Patients who took a 12-milligram dose of retatrutide lost 17.5% of their body weight, or 41 pounds, on average after 24 weeks, compared with 1.6% for those who received the placebo. Patients lost 24.2%, or 58 pounds, on average after 48 weeks. Those who took the placebo lost 2.1% of their body weight after that same time period. The trial’s researchers said average weight loss did not appear to plateau after 48 weeks, suggesting a longer study could show even more. Eli Lilly is currently recruiting patients for ...
- Source: drugdu
- 112
- June 29, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.