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Alnylam Pharmaceuticals under fire from the FDA
Thursday May 7 2026
Alnylam, the maker of heart medication Amvuttra[1], is in trouble with the FDA again.
As part of the administration’s crack down on misleading advertising, Alnylam was sent a cease-and-desist letter for what the FDA determined was false or misleading information on Alnylam’s website for Amvuttra. Alnylam has until May 14 to respond and inform the FDA how it will correct its misconduct.
At issue are statements on the company's website claiming that Amvuttra is proven to help patients live longer, that continued treatment extended survival, and that the risk of death was lower over three and a half years of use. The FDA determined that these claims create a misleading impression of the drug's efficacy.
This enforcement action is part of a broader push that began in September 2025, when the FDA signalled it would step up its oversight of direct-to-consumer pharmaceutical advertising.
Recent enforcement has moved beyond traditional advertising into digital. As just one example, the FDA has sent warning letters to dozens of telehealth companies marketing compounded versions of popular weight-loss drugs.
This is not Alnylam’s first offense. In October 2025, the FDA raised concerns about a television advertisement depicting patients travelling and taking part in activities such as whale-watching and attending sporting events. The FDA determined that the ad presented an overly optimistic view of patients' lives while downplaying the seriousness of the condition being treated. Upon being notified by the FDA, Alnylam pulled the ad while it reviewed the agency's feedback.
How Alnylam responds will be closely watched. Its reply, due by mid-May, will not only indicate how it plans to revise its marketing going forward, but serve as an early test of whether the FDA's tougher stance is reshaping industry behavior.
[1] Amvuttra is approved to treat transthyretin-mediated amyloidosis (also known as ATTR-CM), a rare and serious heart condition.
The GLP-1 Bubble Pharma Can't Afford to Ignore
Wednesday May 6 2026
For the third consecutive year, the top global pharmaceutical companies have increased their return on research and development. But internal analysis circulating within the industry tells a more uncomfortable story.
The forecast internal rate of return across the top 20 biopharma companies rose from 5.9% in 2024 to 7.0% in 2025. That improvement is not the product of broad-based innovation. It is being driven almost entirely by GLP-1 drugs — medicines targeting obesity and diabetes — which now account for 38% of projected pipeline sales. Remove GLP-1s from the equation, and the industry's rate of return collapses to 2.9%. The rest of the pipeline is barely breaking even.
What has emerged — and what senior figures are privately acknowledging — is something that looks increasingly like a bubble. Of the 108 blockbuster drugs in advanced development, just 54 assets represent 9% of the pipeline yet are forecast to deliver around 70% of total projected sales. A single regulatory setback or clinical failure could send shockwaves across the entire sector. Meanwhile, the average cost to bring a drug to launch has risen to $2.67 billion, up from $2.23 billion a year ago.
There are traces of genuine innovation beneath the surface. The share of drugs with novel mechanisms of action has risen from 35% to 53% of pipeline value in a single year. But even here, GLP-1 drugs claim 60% of that tier. The industry's most innovative segment is not insulated from the same concentration risk that defines everything else.
The question being asked in boardrooms, if not yet in public, is whether GLP-1 revenues will fund the diversification the industry needs — or whether the dependency runs too deep to unwind before the next shock arrives.
Inside the $5 Billion Reckoning: What Purdue’s Sentencing Really Exposes
Tuesday May 5 2026
This week, one of the most consequential corporate enforcement actions in pharmaceutical history reached a new milestone. In a federal court in Newark, opioid manufacturer Purdue Pharma was sentenced to pay more than $5 billion in criminal penalties for its role in the opioid crisis.
But behind the headline figure lies a deeper story about how the system was allegedly exploited.
According to court findings, Purdue spent years marketing opioid products to prescribers it had reason to believe were issuing prescriptions without legitimate medical purpose. At the same time, it misrepresented its compliance efforts to the Drug Enforcement Administration, using those same prescriptions to justify requests to manufacture more opioids.
The incentives did not stop there. Prosecutors outlined how Purdue paid kickbacks through speaker programmes and an electronic health records platform to encourage higher prescription volumes. These practices formed the basis of conspiracy charges, including violations of the Federal Anti-Kickback Statute.
The financial penalties include a $3.544 billion criminal fine and $2 billion in forfeiture, with portions tied to ongoing bankruptcy proceedings. The company has already pleaded guilty to felony charges linked to fraud and unlawful marketing.
For whistleblowers and regulators, the case highlights a critical issue. Enforcement is not just about punishing past conduct, but exposing how internal systems can be used to sustain it. The requirement for a public document repository signals a push toward transparency, offering a rare window into corporate decision-making.
This is more than a sentencing. It is a reminder that the mechanisms behind drug promotion, compliance, and reporting can shape outcomes on a national scale and that when those systems fail, the consequences can be measured in lives as well as dollars.
The $0.01 Warning Big Pharma Can’t Ignore
Tuesday May 5 2026
A recent ruling from the Ninth Circuit Court of Appeals has quietly redrawn the legal landscape for pharmaceutical pricing and could have major consequences for how drug companies operate behind the scenes.
In United States ex rel. Adventist Health System/West v. AbbVie Inc., the court revived claims that several major manufacturers including AbbVie, AstraZeneca, Novartis and Sanofi may have overcharged under the federal 340B drug pricing program.
At the center of the case is “penny pricing.” Under the 340B system, if drug prices rise faster than inflation, companies may be required to sell medicines to certain healthcare providers for as little as $0.01 per unit. The whistleblower alleged that manufacturers ignored this formula for years, instead applying their own pricing methods, before sharply reducing prices following a 2019 regulatory change.
The financial implications are substantial. Inflated prices can lead to higher reimbursements from Medicaid and Medicare. This is where the False Claims Act becomes relevant. The Ninth Circuit confirmed that even without a direct right to sue under 340B rules, claims can still be brought on behalf of the government if fraud is involved.
The ruling makes one thing clear. Pharmaceutical pricing practices are no longer insulated from scrutiny simply because they sit within a regulatory framework. If proven, these allegations could expose companies to significant liability and bring renewed attention to how pricing decisions are made in program designed to support vulnerable patients.
Something Bigger Is Coming
Tuesday April 14 2026
We weren’t planning on posting this yet.
Over the last few days, a few things have come in that don’t look like the usual fragments. Not a screenshot here, a draft there. This is different. It’s structured. It’s consistent. And it lines up in a way that’s hard to ignore.
Same names appearing across documents that shouldn’t be connected. Edits happening at the same stage, across separate trials. Language being changed in ways that aren’t accidental.
Individually, none of it would be enough to publish.
Together, it starts to look like a system.
We’re still going through it. Cross-checking, stripping out anything that could point back to sources, making sure we’re not jumping ahead of what’s actually there.
But this isn’t noise.
Give us a little time.
If you’re sitting on something that might connect to this, now would be the moment to send it through.
More soon.
If You’ve Seen It, Send It
Saturday April 11 2026
If you’ve made it this far, you don’t need a lecture on why this matters.
You’ve seen how things get handled. You’ve watched language change between drafts. You’ve probably sat in meetings where something real got quietly reworded into something harmless.
That’s usually where it stops.
It doesn’t have to.
If you’re inside and you’ve got something that shouldn’t be buried, send it through. Doesn’t need to be perfect. Doesn’t need a full story. Half a thread is still a thread.
Use a personal device. Don’t overthink it. Strip out anything that points straight back to you if you’re worried. We’re not interested in names, only what’s being said behind the scenes.
Send it to: nfksbysapwib8d91rs3tbkqo@proton.me
No introductions needed. No explanation required.
We’ll take it from there.
Unfiltered Pharma
Tuesday April 7 2026
PharmaLeaks isn’t a brand, and it’s definitely not a company.
It’s just a site that exists because too many things don’t get said out loud.
People send us stuff. Sometimes it’s a forwarded email chain that shouldn’t have left the building. Sometimes it’s a draft report with half the important lines quietly stripped out before publication. Sometimes it’s just a screenshot taken at the right moment. It comes from all over: labs, agencies, consultancies, places that are supposed to be buttoned up.
The US pharma world runs on layers. By the time anything reaches the public, it’s been cleaned, shaped, signed off and softened. The rough edges don’t make it through. The inconvenient bits get buried in footnotes, or pushed into “further research”, or just disappear.
We’re not here to polish anything. We put things up as we get them, with as little interference as possible. That means it can be messy. Out of order. Occasionally incomplete. That’s the reality of leaks.
Over time, it adds up.
We’re not pretending this is objective or balanced. It’s not meant to be. It’s meant to show you what things look like before they’re tidied away.
If you’re reading this, you probably already get why that matters.
If you’ve got something, you know where to send it.