Exenatide

FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings

14 hours ago

• The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book. • The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications. • According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.

Weight Loss Injections Show Promising Anti-Cancer Effects Beyond Weight Reduction

10 days ago

• Research presented at the European Congress on Obesity suggests weight loss injections may reduce obesity-related cancer risk by nearly 50%, potentially through anti-inflammatory mechanisms beyond simple weight reduction. • Scientists from the University of Manchester are designing a large-scale clinical trial involving tens of thousands of patients to further investigate GLP-1 agonists as cancer prevention tools. • Experts believe these findings could herald a "new dawn" in preventative cancer medicine, potentially benefiting even non-obese individuals with high cancer risk factors.

Vivani Medical Achieves First GLP-1 Implant and Full Enrollment in LIBERATE-1 Trial for Obesity Treatment

2 months ago

• Vivani Medical has successfully administered its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial, marking a significant advancement in addressing medication adherence challenges in metabolic diseases. • The company achieved full enrollment of 24 subjects within just four weeks, demonstrating strong interest in this twice-yearly subdermal implant that could provide an alternative to daily oral and weekly injectable treatments. • NPM-115, Vivani's lead GLP-1 implant, has shown comparable preclinical weight loss to semaglutide (Ozempic/Wegovy) and aims to improve medication adherence, with top-line results expected by mid-2025.

AstraZeneca's Bydureon Shows No Benefit in Phase III Parkinson's Disease Trial

3 months ago

• A Phase III trial led by University College London reveals AstraZeneca's diabetes drug Bydureon (exenatide) failed to slow Parkinson's disease progression over 96 weeks. • The study showed disease progression actually worsened in both treatment groups, with MDS-UPDRS III scores increasing by 5.7 points in the Bydureon group versus 4.5 points in placebo. • Despite promising preclinical results and previous evidence of GLP-1 receptor agonists' potential in Parkinson's, the trial delivered definitive negative results while maintaining a similar safety profile to placebo.

GLP-1 Drug Exenatide Shows No Benefit in Large-Scale Parkinson's Disease Trial

4 months ago

• A rigorous 96-week Phase 3 trial involving 194 Parkinson's patients across six UK hospitals found that exenatide, a GLP-1 drug related to Ozempic, showed no benefit in treating or slowing disease progression. • The double-blind study, led by UCL researchers, revealed no improvements in patient movements, symptoms, or brain imaging results, despite earlier smaller studies suggesting potential benefits. • The disappointing results represent a setback for the half million Americans with Parkinson's disease, who currently have treatments for symptoms but no options to slow disease progression.

2025: Cure Parkinson's Research Highlights and Future Insights

5 months ago

Cure Parkinson's reflects on a productive 2024, highlighting key research advancements and clinical trials, including the promising results of lixisenatide and the initiation of new studies like DAPA-PD and low-dose lithium. The organization also looks ahead to 2025, anticipating the start of significant trials such as ASPro-PD and EJS ACT-PD, and the publication of AZA-PD trial results.

FDA Approves New Therapies for Hemophilia, Colorectal Cancer, and Cystic Fibrosis

5 months ago

• The FDA approved Alhemo (concizumab) from Novo Nordisk for hemophilia A and B with inhibitors, offering a once-daily subcutaneous option. • Pfizer's Braftovi (encorafenib) received accelerated approval as a first-line treatment for BRAF V600E-mutated metastatic colorectal cancer in combination with other therapies. • Vertex Pharma's Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a new triplet therapy for cystic fibrosis, has been approved for patients aged six and older with responsive mutations. • Hikma Pharma gains FDA approval for the first generic version of Novo Nordisk's Victoza (liraglutide) for treating type 2 diabetes.

FDA Approves First Generic Liraglutide Injection for Type 2 Diabetes Treatment

5 months ago

• The FDA has approved the first generic version of liraglutide injection, a GLP-1 receptor agonist, for treating type 2 diabetes in adults and children aged 10 and older. • This approval by the FDA is for Hikma Pharmaceuticals' generic version referencing Victoza, offering a more affordable treatment option. • Liraglutide improves blood sugar control by mimicking the effects of GLP-1 in the pancreas, addressing the GLP-1 deficiency often seen in type 2 diabetes patients. • The FDA is prioritizing the review of generic applications for GLP-1 medications due to ongoing shortages, aiming to enhance patient access to these essential drugs.

Vivani Medical's Innovative GLP-1 Obesity Implant Garners Buy Ratings

5 months ago

• Vivani Medical is developing the NPM-115 implant, a 6-month duration GLP-1 drug delivery system for obesity treatment, potentially improving patient compliance. • Phase 1 LIBERATE-1 study in Australia will assess the safety and effectiveness of NPM-115, with preliminary results expected in mid-2025. • Maxim Group and H.C. Wainwright reiterated Buy ratings for Vivani Medical, citing its innovative approach and the growing GLP-1 market.

New Multi-Society Guidance: Most Patients Can Continue GLP-1 RAs Before Endoscopic Procedures

6 months ago

• The American Society of Anesthesiologists and multiple medical societies have released updated 2024 guidance indicating most patients can safely continue GLP-1 receptor agonist therapy before endoscopic procedures, reversing previous recommendations. • The new guidance emphasizes a risk-based, shared decision-making approach between patients and healthcare teams, balancing metabolic needs with individual patient risk factors for complications. • This update comes amid the rapidly expanding use of GLP-1 RAs, with over 137 million US adults now considered eligible for semaglutide across its approved indications for diabetes, obesity, and cardiovascular risk reduction.

Amneal Resubmits FDA Application for Dihydroergotamine Autoinjector to Treat Migraines and Cluster Headaches

6 months ago

• Amneal Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for a dihydroergotamine (DHE) prefilled autoinjector, aimed at treating migraines and cluster headaches. • The resubmission addresses manufacturing concerns previously raised by the FDA, which led to a rejection of the initial application. • If approved, Amneal's product would be the first DHE autoinjector on the market, offering a convenient, ready-to-use solution for patients. • The FDA is expected to complete its review of the NDA in Q2 2025, potentially providing a new treatment option for severe headache sufferers.

GLP-1 Receptor Agonists Show Promise in Curbing Alcohol Abuse, Especially in Obese Individuals

6 months ago

• A new study suggests GLP-1 receptor agonists (GLP-1 RAs) may reduce alcohol consumption by targeting the brain's reward center. • The effect was more pronounced in heavy drinkers with obesity (BMI over 30), indicating a potential therapeutic benefit in this population. • Clinical trials and observational studies showed GLP-1 RA use was associated with reduced alcohol consumption and fewer alcohol-related health issues. • These findings suggest GLP-1 RAs could be a future treatment option for excessive alcohol use, potentially reducing alcohol-related deaths.

GLP-1 Agonists Show Promise in Addiction Treatment: Beyond Weight Loss

6 months ago

• GLP-1 agonists, initially for diabetes and obesity, are being explored for their potential in treating substance use disorders by targeting brain mechanisms. • Studies suggest GLP-1 agonists may reduce cravings for addictive substances by impacting the brain's reward system, showing potential in reducing binge drinking and opioid overdoses. • Clinical trials are underway to investigate the efficacy of GLP-1 agonists like semaglutide in treating various substance use disorders, with results expected in the coming years. • Experts emphasize that while promising, GLP-1 medications should be part of a comprehensive treatment plan, including community support and therapy, for individuals with addiction.

GLP-1 Agonists Show Promise as Potential Drug Therapy for Obstructive Sleep Apnea

7 months ago

• GLP-1 agonists, initially for diabetes and obesity, are gaining traction as a potential pharmacological treatment for obstructive sleep apnea (OSA), especially in obese patients. • Eli Lilly's tirzepatide is under FDA review for OSA treatment based on the SURMOUNT-OSA trial, which showed significant reductions in apnea-hypopnea index (AHI) in participants. • Experts emphasize that GLP-1s are not a standalone solution and should be integrated with lifestyle management and other OSA therapies like CPAP for comprehensive care. • Despite promising results, challenges remain, including supply shortages, high costs, and insurance coverage gaps, potentially limiting access for many patients.

Drug Development Updates