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Novo Nordisk Moves to Restrict Compounded Versions of Ozempic Amid Market Disputes

Novo Nordisk, the pharmaceutical company behind the popular diabetes and weight-loss drugs Ozempic and Wegovy, is actively working to limit compounded versions of these medications in the U.S. The company has petitioned the FDA to add semaglutide, Ozempic’s active ingredient, to the Demonstrably Difficult to Compound (DDC) list. If granted, this designation would bar compounding pharmacies from producing generic-like versions, effectively pushing patients toward FDA-approved products.

Novo Nordisk argues that the complexities involved in compounding semaglutide safely justify their request, citing patient safety concerns as the primary reason. Jamie Bennett, Novo Nordisk’s director of media relations, stressed that compounded versions of semaglutide carry risks of adverse effects due to dosing inconsistencies and quality issues. Although compounded drugs can legally bypass FDA approval when specific criteria are met—such as during drug shortages—the FDA has received reports of side effects associated with compounded semaglutide products.

The backdrop of this move is a broader tension between pharmaceutical companies and the compounding industry, particularly as telehealth providers capitalize on the high demand for GLP-1 drugs like Ozempic. Telehealth clinics and pharmacies often offer compounded versions at a fraction of the price, sometimes as low as $100 monthly compared to the brand-name cost of around $1,000. This market competition has prompted Novo Nordisk to file numerous lawsuits against companies selling compounded alternatives, alleging unfair competition and trademark infringement.

Novo Nordisk is not alone in this push to limit compounded alternatives. Following a similar pattern, Eli Lilly, the producer of tirzepatide (marketed as Mounjaro and Zepbound), also took action recently when the FDA initially declared a resolution to the drug’s shortage, leading to a halt in compounded tirzepatide production. However, this decision was met with resistance, and the FDA is now reassessing tirzepatide’s shortage status, allowing limited compounding to resume.

With semaglutide still listed as in shortage, the compounding industry continues to offer compounded alternatives. However, should this shortage end, compounding pharmacies may find themselves barred from producing these high-demand drugs, heightening the battle between brand-name pharmaceutical giants and independent compounding businesses.

Infostealer Campaigns Surge Amid Global Credential Breaches

Overview Of A Growing Cyber Threat

Recent investigations have revealed that cybercriminals are intensifying their efforts to steal sensitive information through sophisticated infostealer malware. Aggregating credentials from 30 distinct datasets, experts estimate that approximately 16 billion login credentials – from platforms including Apple, Google, and Facebook – have been exposed. This alarming finding underscores a shifting landscape in digital security.

Advanced Evasion And The New Face Of Cybercrime

Volodymyr Diachenko, co-founder of SecurityDiscovery, reports that these coordinated leaks are the product of infostealers, malware designed to bypass traditional, signature-based security measures. While these datasets may contain duplicates or outdated records, their sheer volume evidences how pervasive sensitive data has become on the internet. The phenomenon has earned infostealers the moniker of a modern “cyber plague.”

The Economics Of Cybercrime

Simon Green, president of Asia-Pacific and Japan at Palo Alto Networks, notes that modern infostealers employ advanced evasion techniques, making them uniquely challenging to detect. Furthermore, the rise of cybercrime-as-a-service models has democratized access to these malicious tools. Underground marketplaces facilitate the trade of stolen credentials and malware kits, effectively lowering the barriers for operators to launch expansive and coordinated attacks.

Corporate And Individual Defense Strategies

Given the increasing prevalence of malware, security experts advise both individuals and corporations to adopt proactive measures. From regular password updates and the implementation of multi-factor authentication for individuals, to the deployment of a “zero trust” architecture by enterprises, enhancing digital defenses is paramount. Recent international efforts, such as Europol’s collaboration with Microsoft to disrupt the ‘Lumma’ infostealer network, illustrate the critical need for coordinated global responses to these threats.

Conclusion

The surge in infostealer activity is a clear indicator of evolving cybersecurity challenges. As billions of credentials continue to circulate the web, both public and private sectors must intensify their cybersecurity measures to counter these sophisticated threats effectively.

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