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Zepbound Copycats Remain Online Despite FDA Ban

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Zepbound Copycats Remain Online Despite FDA Ban

Compounding Pharmacies Defy FDA Ban on Copycat Versions of Weight-Loss and Diabetes Drugs

This week was supposed to mark the end of compounding pharmacies making copycat versions of Eli Lilly’s weight-loss drug Zepbound and diabetes drug Mounjaro. However, online, it doesn’t look like much has changed.

Popular websites like Amble, EllieMD, Willow, and Mochi Health are still advertising versions of tirzepatide, the active ingredient in Zepbound. Some, like Ivim, have stopped taking new patients. Mochi Health, however, has no plans to stop, and neither do the four pharmacies it uses to supply patients with the medications. The company uses a network of about 500 providers to write prescriptions for weight-loss drugs, including compounded versions.

Personalization is Key

According to Mochi CEO Myra Ahmad, offering personalized versions of the drugs will keep the company out of the crosshairs. "It can be different dosing schedules … some patients prefer to go up in dosage much more slowly," she said. "Some patients like to mix a number of other medications into their compounded formulations, depending on the side effects that they’re having. Some patients have side effects with any additives and brand name formulations. Compounding really opens up the door for so much personalization."

What is Compounding?

Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients. Say someone is allergic to a dye in a branded medication or needs a liquid form and the main manufacturer only sells capsules. In that case, the patient can turn to a compounded version. When drugs are in short supply, they can be compounded in larger quantities to help fill the gap.

FDA Guidance

The FDA has been clear about what is and is not a copy. According to the agency, a copy is a product that has a dosage within 10% of the commercially available drug or combines two or more commercially available drugs. Mochi insists all of its prescriptions are personalized, including doses that differ from the standard Zepbound strengths. Other websites like EllieMD are advertising tirzepatide mixed with vitamin B12.

What’s Next?

The next two months will be informative. Mass compounding of semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, needs to stop by the end of May, according to the FDA. Hims & Hers Health has already said it will stop selling commercially available doses of semaglutide when the time comes. Customers who have a personalized dosing regimen will be able to continue without any change.

Conclusion

The FDA’s ban on mass compounding of tirzepatide and semaglutide has left many pharmacists and patients in a difficult position. While some pharmacies like Mochi Health have found a way to continue offering personalized versions of the drugs, others like Ivim have stopped taking new patients. The next few months will be crucial in determining the future of compounding pharmacies and their role in the healthcare industry.

FAQs

Q: What is compounding?
A: Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients.

Q: Why are some pharmacies still offering copycat versions of Zepbound and Mounjaro?
A: Some pharmacies believe that offering personalized versions of the drugs will keep them out of the crosshairs.

Q: What is the FDA’s stance on compounding?
A: The FDA sees copies as products that have a dosage within 10% of the commercially available drug or combine two or more commercially available drugs.

Q: What happens if pharmacies continue to offer copycat versions of tirzepatide and semaglutide?
A: Pharmacies that continue to offer copycat versions of the drugs may be putting themselves at risk of legal action from the FDA and drug manufacturers.

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Global Trends and Politics

Chinese tea chain Chagee files for U.S. IPO

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Chinese tea chain Chagee files for U.S. IPO

Chinese Tea Chain Chagee Files for US IPO, Aims to Expand Globally

Chagee, a Chinese bubble tea chain, has filed for an initial public offering (IPO) on the Nasdaq, seeking to trade under the ticker symbol "CHA". The company, which was founded in 2017, has grown rapidly to over 6,400 locations across China, Malaysia, Singapore, and Thailand, with 97% of its locations in China.

A Modern Approach to Tea

Founder and CEO Junjie Zhang created Chagee with the goal of modernizing the traditional Chinese tea culture, inspired by the success of international coffee companies. China is Starbucks’ second-largest market, and Chagee aims to capitalize on the growing demand for tea in the country.

Global Expansion Plans

Chagee plans to expand its global presence, serving tea lovers in 100 countries, generating 300,000 employment opportunities worldwide, and delivering 15 billion cups of freshly brewed tea annually. The company’s first US store is set to open in the Westfield Century City mall in Los Angeles this spring.

Challenges Ahead

Chagee’s IPO comes as relations between the US and China have grown frostier, leading to increased scrutiny of Chinese companies seeking a US listing. Shein, another Chinese e-commerce company, has opted for a London IPO after lawmakers pushed back on its plans to go public on a US exchange. US investors may also be cautious about investing in another Chinese beverage chain following the example of Luckin Coffee, which was delisted from the Nasdaq after inflating its sales.

A Familiar Story

Luckin Coffee, founded in 2017, grew rapidly and went public on the Nasdaq in 2019. However, it was later discovered to have fabricated its sales, leading to its delisting and bankruptcy. The company re-emerged in 2022, minus the executives responsible for the fraud, and has since overtaken Starbucks as China’s largest coffee retailer by sales.

Conclusion

Chagee’s IPO filing marks an important step in its expansion plans, but the company will need to navigate the challenges posed by the complex US-China relations and investor skepticism. With its focus on modernizing the tea culture and its ambitious global expansion plans, Chagee has the potential to make a significant impact in the global tea market.

Frequently Asked Questions

Q: What is Chagee’s ticker symbol?
A: Chagee plans to trade on the Nasdaq under the ticker symbol "CHA".

Q: How many locations does Chagee have?
A: As of December 31, the company has over 6,400 locations across China, Malaysia, Singapore, and Thailand, with 97% of its locations in China.

Q: What is Chagee’s revenue?
A: In 2024, Chagee generated revenue of $1.7 billion, with net income of $344.5 million.

Q: What are Chagee’s expansion plans?
A: The company aims to expand its global presence, serving tea lovers in 100 countries, generating 300,000 employment opportunities worldwide, and delivering 15 billion cups of freshly brewed tea annually.

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Global Trends and Politics

Pennsylvania Nurses Advocate for Health Care Workplace Violence Prevention Act

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Pennsylvania Nurses Advocate for Health Care Workplace Violence Prevention Act

In Pennsylvania, over 11,000 nurses and health care professionals are urging lawmakers to pass the Health Care Workplace Violence Prevention Act, aiming to enhance safety measures in health care settings.

Addressing Rising Concerns

The push for this legislation comes amid increasing concerns about workplace violence in health care environments. Health care workers often face higher risks of violence compared to other professions, making the need for comprehensive protective measures critical.

Key Provisions of the Act

The proposed act seeks to implement mandatory workplace violence prevention programs in health care facilities across the state. These programs would include:

  • Risk Assessment: Identifying potential hazards that could lead to violent incidents.

  • Staff Training: Educating employees on de-escalation techniques and safety protocols.

  • Incident Reporting: Establishing clear procedures for reporting and responding to violent events.

PASNAP’s Endorsement

The Pennsylvania Association of Staff Nurses and Allied Professionals (PASNAP), representing over 11,000 members, has been a vocal supporter of the bill. The organization emphasizes that ensuring the safety of health care workers is essential for maintaining high-quality patient care.

Legislative Progress

The Health Care Workplace Violence Prevention Act has successfully passed through committee stages in the Pennsylvania State House. Advocates are now calling for swift action from the full House to enact the legislation.

If passed, this act would mark a significant step toward safeguarding health care workers, potentially serving as a model for similar initiatives nationwide. Enhanced safety protocols could lead to improved job satisfaction, reduced turnover, and better patient outcomes.

As the bill advances, health care professionals and stakeholders remain hopeful that Pennsylvania will prioritize the well-being of those on the front lines of patient care.

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Global Trends and Politics

The Intersection of Business and Politics: A New Era of Corporate Social Responsibility

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The Intersection of Business and Politics: A New Era of Corporate Social Responsibility

The world is changing, and the way we do business is no exception. With the rise of globalization, social media, and environmental concerns, companies are being forced to reevaluate their roles and responsibilities in society. Gone are the days of simply focusing on profits; today’s businesses must prioritize social responsibility and sustainability.

A New Era of Corporate Social Responsibility

The concept of corporate social responsibility (CSR) is not new, but its significance has grown exponentially in recent years. Companies are recognizing that their actions have far-reaching implications, from the environment to local communities. This shift in perspective is driving a new era of CSR, where businesses prioritize long-term sustainability and social impact.

The Role of Politics in CSR

Politics plays a significant role in CSR, as governments and regulatory bodies increasingly hold businesses accountable for their actions. Governments are implementing stricter regulations and laws to protect the environment, promote fair labor practices, and ensure transparency in business operations. Companies must adapt to these changes and actively engage with governments to shape policies and regulations that benefit both the environment and the economy.

Examples of Successful CSR-Politics Partnerships

* In 2019, the European Union introduced the EU’s Green New Deal, committing to a climate-neutral economy by 2050. Companies like Siemens and Total have partnered with the EU to develop sustainable energy solutions and reduce carbon emissions.
* In the United States, companies like Patagonia and REI have joined forces with environmental organizations to push for climate action and sustainable practices.

The Benefits of CSR-Politics Partnerships

By partnering with governments and regulatory bodies, businesses can:

* Enhance their reputation and brand image
* Stay ahead of the competition and adapt to changing regulations
* Reduce costs and improve operational efficiency
* Mitigate risks and protect their bottom line
* Contribute to a better, more sustainable future

Challenges and Obstacles

While CSR-politics partnerships offer numerous benefits, they also come with challenges and obstacles, including:

* Conflicting interests and values
* Limited resources and budget constraints
* Complexity and lack of clarity in regulations
* Resistance from stakeholders and the general public

The Future of CSR-Politics

As the world continues to evolve, the intersection of business and politics will only become more critical. Companies must prioritize CSR and actively engage with governments to shape the future of sustainability and social responsibility. By doing so, they can:

* Drive innovation and growth
* Create a better, more sustainable world
* Enhance their reputation and brand image
* Stay ahead of the competition and adapt to changing regulations

Conclusion

The intersection of business and politics is no longer a debate; it’s a reality. Companies must adapt to this new era of corporate social responsibility, prioritizing sustainability and social impact. By partnering with governments and regulatory bodies, businesses can drive positive change, reduce their environmental footprint, and create a better, more sustainable future.

FAQs

Q: What is corporate social responsibility (CSR)?
A: CSR refers to a company’s efforts to contribute to the well-being of society and the environment, while also increasing profitability.

Q: Why is CSR important?
A: CSR is essential for businesses to adapt to changing societal values, reduce risks, and enhance their reputation and brand image.

Q: What are some examples of successful CSR initiatives?
A: Companies like IKEA, Coca-Cola, and Microsoft have implemented successful CSR initiatives, such as reducing energy consumption, promoting fair labor practices, and supporting local communities.

Q: How do I get started with CSR?
A: Start by conducting a CSR assessment to identify areas for improvement, set clear goals and objectives, and develop a strategic plan for implementation.

Q: What are some challenges faced by companies in implementing CSR initiatives?
A: Common challenges include limited resources, conflicting priorities, and resistance from stakeholders and the general public.

Q: Can CSR really make a difference?
A: Yes, CSR can have a significant impact on society, the environment, and the economy. By prioritizing CSR, businesses can drive positive change, reduce their environmental footprint, and create a better, more sustainable future.

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