PhRMA loses another court battle

Florida, Colorado, and other states: We want to let companies import cheaper drugs from Canada.

FDA and HHS: Maaaaaybe. Show us your plans and we’ll decide.

Pharma companies (via PhRMA): No way, José! Off to court!

DC Circuit Court: Has this program hurt you, PhRMA?

PhRMA: Not yet, but it could.

DC Circuit Court: Can you use this doll and point to where the bad plan hurt you?

PhRMA: Well, there aren’t any plans yet. But if there were, they could hurt!

DC Circuit Court: Go away. “Plaintiffs nowhere allege that their ability to provide services has been ‘perceptibly impaired’ or describe any ‘inhibition’ of their ‘daily operations’.”

Breast-cancer treatment in a pill

Women with late-stage, treatment-resistant breast cancer can now take a pill instead of enduring monthly injections. The FDA has approved Orserdu (its friends call it elacestrant). Here’s the kicker: It’s a 30-year-old drug that failed as a dementia treatment and for helping with hot flashes.

But the reason it failed against those hot flashes is the same reason it works against cancer: It breaks down estrogen receptors, preventing tumors from growing and metastasizing.

Six months after treatment started, about 34% of patients on elacestrant had survived without their cancer progressing, compared to about 20% of patients on other treatments.

STOP THE PRESSES

Whooping-cough vaccine for newborns protects newborns from whooping cough.

Know your codes

If you’re dispensing a GLP-1 analog — dulaglutide, semaglutide, tirzepatide — NCPA and the Pharmacy Audit Assistance Service strongly recommend that you document the ICD-10 diagnosis code.

If the prescription doesn’t have a diagnosis code, don’t take the patient’s word for it; call and get the code from the prescriber’s office and document the conversation, including the date and the full name of the person who gave the information.

“If it seems like a hassle,” writes NCPA, “think about the bigger hassle of getting an audit.”

Two peanut-allergy breakthroughs

From Notre Dame and Indiana University

Chemical engineers have developed an injection that protected mice against peanut-allergy reactions for two weeks. It’s a cHBI inhibitor that…

”…effectively masks the immune system’s ability to recognize the allergen, allowing it to fly under the immune system’s radar without initiating a dangerous response or compromising its ability to fight real pathogens.”

Even better: It can also be used to stop an allergic reaction soon after it starts, kinda like an EpiPen.

Even better better: The technology is actually a platform that can also be used for “developing inhibitors to treat a range of other allergies such as shellfish and penicillin.”

From the University of Chicago

Knowing that butyrate can prevent food allergies, and that it’s produced by certain bacteria in the gut, molecular engineers created micelles — a special type of polymer — that can deliver butyrate to the intestines instead of being destroyed in the stomach, as a pill would be.

Cool beans: Changing the charge on those micelles can determine where in the GI system they release their payload. Once there, the butyrate does double duty: It can help prevent allergies on its own, but is also helps Clostridia bacteria in the gut thrive — and Clostridia also produces butyrate.

When mice that were allergic to peanuts were treated with the butyrate micelles, they did not have an anaphylactic response when presented with a peanut challenge.

Human trials are next.

The Long Read: CBD Mythbusting edition

A pharmacologist unpacks what CBD can (probably) do … and what it (probably) can’t.

CBD is what pharmacologists call a promiscuous drug. That means it could be effective for treating a number of medical conditions. In broad strokes, CBD affects more than one process in the body — a term called polypharmacology — and so could benefit more than one medical condition.