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Wednesday, April 23, 2025

Lilly Sues 4 GLP-1 Telehealth Startups, Escalating War on Knockoff Drugs

On Wednesday, pharmaceutical giant Eli Lilly sued four prominent telehealth companies that offer more affordable, off-brand versions of its patented best-selling GLP-1 medications Mounjaro and Zepbound. Together, the drugs accounted for over $16.4 billion in revenue for the company last year. It’s the latest escalation in an ongoing war between the drug industry and health care providers over what are widely seen as the most effective—and lucrative—drugs for treating obesity and diabetes to come on the market in years.

The lawsuits target four telehealth brands, Mochi Health, Fella & Delilah Health, Willow Health, and Henry Meds. Eli Lilly alleges that each company is selling illegal knockoffs of its drugs, in some cases, with untested added ingredients like vitamins and amino acids in an attempt to distinguish them from its name-brand medications.

None of the companies named as defendants immediately responded to requests for comment from WIRED about the lawsuits. In response to general questions about its business practices, Mochi Health said in a statement that it offers compounded GLP-1 medications that are “customized for medical necessity."

“Their use remains appropriate and legal when tailored to individual patient needs and prescribed by a licensed medical provider—not as mass-market substitutes for branded medications,” Mochi Health said. Fella & Delilah Health, Willow Health, and Henry Meds did not respond to questions about its business practices in time for publication.

Lilly previously filed other lawsuits against more than a dozen compounding pharmacies, medical spas, and wellness centers for selling drugs claiming to contain tirzepatide, the active ingredient in both Zepbound and Mounjaro.

Mounjaro surged in popularity after it was approved to treat diabetes in May 2022, and the FDA declared some doses of it were in shortage by the end of that year. Zepbound was approved as an obesity treatment in November 2023, with certain doses going into short supply months later. (Novo Nordisk’s competing GLP-1 medications, Ozempic and Wegovy, also went into shortage in 2022.)

When there’s an official shortage of a drug, compounding pharmacies are legally allowed to create duplicate copies or custom-mixed approximations known as “compounds” to meet patient needs. These off-brand versions are not approved by the FDA—but they are often far more affordable than name-brand medications.

During the years-long tirzepatide and semaglutide shortages, which the FDA officially declared over in December and February, compounded GLP-1s became widely available through existing telehealth providers and startups that sprang up specifically to cash in on the new, lucrative health care niche. According to a trade group representing compounders, at least 2 million people in the US were taking these medications as of November last year.

Some telehealth companies offered vials of tirzepatide for under $100, a fraction of the cost of Mounjaro and Zepbound, and shipped them to patients within days after they filled out a quick online questionnaire.

While most telehealth brands and compounding pharmacies do not disclose their revenue, industry juggernaut Hims said during a recent earnings call that it brought in about $225 million from GLP-1 drug sales last year. (Hims no longer sells compounded tirzepatide, but recently added branded Zepbound to its offerings.)

Lilly’s lawsuit against Willow Health Services alleges that the Texas-based telehealth company falsely markets some of its products, such as an oral droplet GLP-1 drug and a version of compounded tirzepatide with added niacinamide added, as “custom-prepared” for patients despite being mass-produced.

Some companies selling compounded GLP-1 meds are unlikely to stop without a fight. A compounding trade group has filed a set of lawsuits against the FDA on behalf of clients, arguing that the agency prematurely declared the GLP-1 shortages over. Whether or not their legal efforts are successful, there’s still a possibility that the drugs could once again go into shortage if demand continues to rise. As new research continues to point to additional medical uses for these drugs, that may very well happen.

“Pharmacies compound medication all the time, and there are no lawsuits about it because they’re not trying to compete with drug companies,” Lambert says. “This is so contentious because there’s so much money at stake.”

https://www.wired.com/story/glp-1-compounding-fda-lawsuits/

Boston Scientific Beats Q1 Sales Targets, Next Quarter’s Sales Guidance Optimistic

Medical device company Boston Scientific (NYSE:BSX) reported revenue ahead of Wall Street’s expectations in Q1 CY2025, with sales up 20.9% year on year to $4.66 billion. Guidance for next quarter’s revenue was better than expected at $4.88 billion at the midpoint, 2% above analysts’ estimates. Its non-GAAP profit of $0.75 per share was 11.5% above analysts’ consensus estimates.

Boston Scientific (BSX) Q1 CY2025 Highlights:

Revenue: $4.66 billion vs analyst estimates of $4.57 billion (20.9% year-on-year growth, 2% beat)
Adjusted EPS: $0.75 vs analyst estimates of $0.67 (11.5% beat)
Revenue Guidance for Q2 CY2025 is $4.88 billion at the midpoint, above analyst estimates of $4.79 billion
Management raised its full-year Adjusted EPS guidance to $2.91 at the midpoint, a 2.5% increase
Operating Margin: 19.8%, up from 17.5% in the same quarter last year
Organic Revenue rose 18.2% year on year (13.1% in the same quarter last year)
Market Capitalization: $140.6 billion

"We delivered an exceptional quarter to start the year, reflecting the effectiveness of our highly engaged global team and the strength of our product portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific.

https://finance.yahoo.com/news/boston-scientific-nyse-bsx-beats-103944359.html

'UK: Experiments to dim the Sun get green light'

Experiments to dim sunlight to fight global warming will be given the green light by the Government within weeks.

Outdoor field trials which could include injecting aerosols into the atmosphere, or brightening clouds to reflect sunshine, are being considered by scientists as a way to prevent runaway climate change.

Aria, the Government’s advanced research and invention funding agency, has set aside £50 million for projects, which will be announced in the coming weeks.

Prof Mark Symes, the programme director for Aria (Advanced Research and Invention Agency), said there would be “small controlled outdoor experiments on particular approaches”.

“We will be announcing who we have given funding to in a few weeks and when we do so we will be making clear when any outdoor experiments might be taking place,” he said.

“One of the missing pieces in this debate was physical data from the real world. Models can only tell us so much.

“Everything we do is going to be safe by design. We’re absolutely committed to responsible research, including responsible outdoor research.

“We have strong requirements around the length of time experiments can run for and their reversibility and we won’t be funding the release of any toxic substances to the environment.”

Geoengineering projects which seek to artificially alter the climate have proven controversial, with critics arguing they could bring damaging knock-on effects, as well as being an unhelpful distraction from lowering emissions.

However, scientists are increasingly concerned that carbon dioxide levels are not falling fast enough and that further action may be needed to prevent catastrophic warming.

One major area of research is Sunlight Reflection Methods (SRM), which includes Stratospheric Aerosol Injection (SAI) whereby tiny particles are released into the stratosphere to reflect sunlight.

Another potential solution is Marine Cloud Brightening (MCB) in which ships would spray sea-salt particles into the sky to enhance the reflectivity of low-lying clouds.

Shipping fumes

In recent decades, experts noticed that the clouds above shipping routes were far brighter than usual, as pollution caused them to become more reflective, bringing an overall dimming effect.

This cooling from shipping fumes was so marked, that when international regulations were enacted to curb sulphur dioxide emissions in 2020, it caused a spike in global warming, scientists believe.

Prof Jim Haywood, of Atmospheric Science, at the University of Exeter, said: “If you inject small particles into clouds you can brighten them hence reflecting more sunlight back out to space.

“How do we know this could work? Well there are a couple of very strong pieces of evidence.

“Ship emissions from the smoke stack into the marine environment lead to bright lines in clouds over the ocean.

“Then there was a volcanic eruption in Iceland in 2014 which spilled out a lot of sulphur dioxide. What this does is it brightens clouds and cools the planet. What we need to do is some form of field experiments.”

Seeding cirrus clouds

Other ideas for geoengineering include seeding cirrus clouds to allow more heat to escape into space. Currently, the wispy high-altitude clouds act as a blanket, trapping in heat.

Dr Sebastian Eastham, a senior lecturer in Sustainable Aviation at Imperial College London, said: “Every time you fly, sulphur, which is naturally present in jet fuel, is emitted into the lower most stratosphere causing a small cooling effect.

“Similarly, aircraft contrails cause accidental cirrus cloud modification but in this case accidentally causing, rather than preventing or thinning, cirrus clouds.

“This points to the fact that it’s theoretically possible (to cool the planet) with current day technology but there are many practical questions that would need to be answered before they could be done at scale.”

Experts are hopeful that if experiments prove a success, they could be scaled up and implemented within 10 years.

As well as outdoor experiments, Aria will also be funding new modelling studies, indoor tests, climate monitoring and gauging public attitudes to geoengineering.

https://www.yahoo.com/news/experiments-dim-sun-green-light-191707344.html

Bessent rips IMF over woke ‘mission creep’

Treasury Secretary Scott Bessent ripped the International Monetary Fund on Wednesday for focusing its resources on promoting woke causes instead of economic stability.

Speaking at the Institute of International Finance forum in Washington, DC, Bessent accused the IMF of “mission creep,” claiming that the agency “devotes disproportionate time and resources to work on climate change, gender, and social issues.”

“Focus on these areas is crowding out its work on critical macroeconomic issues,” Bessent said. “The IMF has been whistling past the graveyard.”

Bessent, 63, also warned IMF’s partner institution the World Bank, a development lender that claims to eliminate poverty and fight climate change, that it needs to rein in excessive spending.

The founder of the Key Square Group investment firm said officials there “should no longer expect blank checks for vapid, buzzword-centric marketing accompanied by half-hearted commitments to reform” and that it must be “fit for purpose again.”

“The IMF and World Bank serve critical roles in the international system. And the Trump administration is eager to work with them, so long as they can stay true to their missions,” Bessent said.

He urged both bodies “to refocus on their core missions” and said they would be “held accountable.”

The Post has approached the IMF and World Bank for comment.

“American dominance of these institutions is still a huge part of America First,” one source familiar with the matter told The Post.

Bessent also took aim at Beijing’s Chinese Communist Party for “ exporting its way out of its economic troubles.”

Bessent’s remarks came just a day after the D.C.-based institution slashed its growth forecast for the US economy.

Experts cited continued uncertainty over Trump’s Liberation Day tariffs as the main reason why they cut expectations for 2025 1.8% from the 2.7% in January.

“The April 2 Rose Garden announcement forced us to jettison our projections,” chief IMF economist Pierre-Olivier Gourinchas said on Tuesday.

“The common denominator is that tariffs are a negative supply shock for the economy, which is imposing them,” he added.

Bessent told the audience in D.C. earlier that “more than 100 countries” had approached the current administration for talks since the announcement of the so-called reciprocal tariffs earlier this month.

The IMF was created out of the Bretton Woods Conference in 1944 in the New Hampshire when the US, the UK, and the former Soviet Union discussed how to shape the post-WW2 global economy.

The 190-member body is often described as a lender of last resort because it helps bail out debt-laden economies, although critics say that it often demands austerity measures that are too harsh.

This global financial firefighter was at the forefront of the European debt crisis in 2008 when Eurozone economies were sent into meltdown after the collapse of Lehman Brothers.

It asked nations such as Greece, Ireland, and Spain to slash social spending and trim back the public sector in return for loans backed by richer IMF members.

Ironically, officials at the global lender also enjoy lavish perks virtually unheard of in the private sector and many people in the countries that take its loans can only dream of..

The Post revealed in December how its staffers can gain cut-rate access to an upmarket Maryland golf and country club that costs regular Joes at least $20,000 to join.

The IMF’s top directors can rake in around $437,000 annually, compared with $52,000 for junior staffers, according to the latest publicly available salary information.

They can also pick up eye-popping retirement benefits, including “a generous final salary” pension and comprehensive worldwide health insurance

https://nypost.com/2025/04/23/business/treasury-secretary-scott-bessent-blasts-the-imfs-woke-mission-creep/

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