FDA Panel Likely To Recommend New Alzheimer’s Drug Approval: Reports
News outlets report on the FDA panel's meeting, set for today. The FDA doesn't have to follow any recommendation made concerning Leqembi, but typically does. In other news, the FTC investigation into pharmacy benefit managers broadend to include Emisar Pharma Services.
The Hill:
FDA Panel To Vote On Alzheimer’s Drug
The FDA panel meeting Friday is likely to recommend full approval, and the agency has a deadline of July 6 to make a determination. The FDA doesn’t have to follow the panel’s recommendation, but it usually does. FDA staff in a briefing document were largely positive about the drug and indicated that data from a clinical trial supported Leqembi’s clinical benefit to patients. (Weixel and Choi, 6/8)
Stat:
Tracking The FDA Advisory Panel On Eisai And Biogen’s Treatment For Alzheimer’s Disease
The Food and Drug Administration is convening a meeting of outside experts on Friday to consider full approval for Leqembi, the Alzheimer’s treatment made by Eisai and Biogen. We’ll be watching a livestream of the FDA advisory meeting, starting at 10 a.m. ET, and writing updates and analysis throughout the day. Coverage will be posted in reverse chronological order. (Feuerstein and Garde, 6/9)
In other pharmaceutical news —
Modern Healthcare:
FTC Pharmacy Benefit Manager Probe Expands To Emisar Pharma
A Federal Trade Commission investigation into pharmacy benefit managers and group purchasing organizations continues to broaden. On Thursday, the FTC issued a compulsory order to Emisar Pharma Services requiring it to turn over information about its business practices. The GPO negotiates rebates with drug manufacturers on behalf of UnitedHealth Group subsidiary OptumRx. The company has 90 days to provide the records. (Berryman, 6/8)
The Washington Post:
Opioid Distributor, Already Facing License Revocation, Sued By Tribe
Morris & Dickson, one of the nation’s largest drug distributors, was sued Thursday over claims that it fed a devastating addiction crisis within the Cherokee Nation by not stopping the suspicious shipment of millions of painkillers to a small number of Oklahoma pharmacies. The negligence lawsuit was filed by the tribe in Oklahoma state court nearly two weeks after the Drug Enforcement Administration, in a separate matter, announced that it would revoke the company’s ability to distribute controlled substances unless Morris & Dickson can reach a settlement agreement with the agency. The company is fighting that move in federal court, saying the revocation would force the company to close after 180 years in business. (Ovalle, 6/8)
NBC News:
New Drug For Marijuana Addiction Shows Promise, Small Study Finds
As marijuana use in the United States reaches record highs among young adults, there is a growing need to address its potential for addiction, experts say. An experimental pill, the first in a new class of drugs, has shown promise in treating cannabis use disorder, according to the results of a small trial published Thursday in Nature Medicine. (Syal, 6/8)
Stat:
CRISPR Therapy Offers Lasting Benefits For Sickle Cell, Thalassemia
Updated results released Friday highlighted the lasting benefits of a CRISPR-based medicine for blood disorders developed by Vertex Pharmaceuticals and CRISPR Therapeutics, as the treatment awaits regulatory decisions in the United States and Europe. The treatment, a one-time infusion known as exa-cel, uses CRISPR to fix the genetic faults at the root of sickle cell disease and beta thalassemia. The latest findings were described Friday, coinciding with the European Hematology Association’s annual meeting in Frankfurt. (Joseph, 6/9)
NPR:
He Jiankui, Chinese Scientist Scorned For Gene-Edited Babies, Is Back In The Lab
In a mostly empty coworking office on the outskirts of China's capital, a scientist whose name is etched in history is trying to stage a comeback. He Jiankui announced nearly five years ago that he had created the first gene-edited babies, twin girls named Lulu and Nana. The news sent shockwaves around the world. There were accusations that the biophysicist had grossly violated medical ethics; some critics compared him to Dr. Frankenstein. (Ruwitch, 6/8)
Stat:
If AI Invents A New Medicine, Who Gets The Patent?
Pharmaceutical and biotech companies are increasingly using artificial intelligence to discover and make drugs and therapeutics. Congress on Wednesday asked the question: Does that mean AI can be an inventor on a patent? (Trang, 6/8)
