cafepharmaApr 4, 2024
Amylyx to pull ALS drug Relyvrio From US, Canada markets after phase III fail—FTC seeks more information on Boston Scientific's $3.7 bln Axonics deal—Novo Nordisk pushes back after price gouging accusations by Bernie Sanders--http://bit.ly/w28kSd #als #amylyx #relyvrio #ftc #bostonscientific #novonordisk #berniesanders #drugpricing #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
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Cafepharma
Show threadEl Club De Los Físicos MuertosMar 18, 2024
Amylyx Pharmaceuticals is a #BioTech #SpinOff of #BrownUniversity -#Providence,#RhodeIsland,USA
that raised uS$ 2.2 million in 2022 from the #ALS Association
through the Ice Bucket Challenge
- it went viral in 2014 -
In 2022 Jan #Amylyx goes public and in Nov. now failed #Relyvrio was approved by US Food and Drugs Administration
http://bit.ly/43qnnIj
Biotech company Amylyx emerges from scientific curiosity of Brown undergrads

Biomedical engineering alumnus Josh Cohen ’14 partnered with Justin Klee ’13 eight years ago to build a company dedicated to the development of therapeutics for the treatment of neurodegenerative disorders.

Engineering | Brown University
El Club De Los Físicos MuertosMar 18, 2024
http://bit.ly/490a7eA
Months ago I was writing about scientific fraud, #BioPharma,new #Drugs and #VentureCapital It is only part of huge #Fraud and #Quackery
Today it is published that in clinical trial, #Relyvrio
of #Amylyx Pharmaceutical, a therapy against amyotrophic lateral sclerosis does not work
Failure of ALS drug puts a spotlight on controversial FDA approvals

A large clinical trial found that Amylyx Pharmaceuticals’ drug to treat ALS doesn’t work, raising questions about the FDA’s process for approving it.

The Washington Post
Zougla.grMar 13, 2024
#RELYVRIO #πλαγία_αμυοτροφική_σκλήρυνση Εξωφρενική σπατάλη στη συνταγογράφηση φαρμάκου για το οποίο τίθεται θέμα απόσυρσης https://www.zougla.gr/ygeia/farmako-nea/exofreniki-spatali-sti-syntagografisi-farmakou-gia-to-opoio-tithetai-thema-aposyrsis/?utm_source=dlvr.it&utm_medium=mastodon
Εξωφρενική σπατάλη στη συνταγογράφηση φαρμάκου για το οποίο τίθεται θέμα απόσυρσης - Zougla

Ο υπουργός Υγείας αναφέρθηκε στην πανάκριβη θεραπεία (περίπου 158.000 δολάρια ετησίως) για την αντιμετώπιση μιας σπάνιας ασθένειας.

Zougla
Holly Fernandez LynchDec 18, 2022

What a mess - one that lies squarely at the company’s feet.
---
RT @AP_FDAwriter
ALS patients who spent years pushing for #Relyvrio's approval are now contending with hurdles posed by its $158,000 price tag, including insurance denials, delays and exorbitant copays.

https://apnews.com/article/health-amazoncom-inc-9d71a833e3199de5a2ea4a56b8ea7584
https://twitter.com/AP_FDAwriter/status/1604488128118546432

ALS patients contend with $158K price tag on new drug

WASHINGTON (AP) — For two years, Becky Mourey pushed the Food and Drug Administration to approve an experimental drug for her Lou Gehrig’s disease. She went to members of Congress and health regulators to make the case for Relyvrio, until patient-advocates finally prevailed.

Associated Press
Holly Fernandez LynchNov 11, 2022

Thanks so much, @PinkSheetSutter, for your incredible #Relyvrio coverage. It's been a fabulous resource to help make sense of what happened and how it fits into a broader context.

https://pink.pharmaintelligence.informa.com/PS147246/Amylyxs-Relyvrio-US-FDA-Review-Shows-Regulatory-Flexibility-Can-Come-In-Many-Forms

Yes!OnlineOct 2, 2022

ALS 新藥獲得批准..

» FDA Approves New Treatment Option for Patients with #ALS https://t.co/jZJeorJIMf // longer overall survival was observed in a post hoc, long-term analysis of patients who originally received #Relyvrio versus those who originally received placebo.
#USgov

FDA Approves New Treatment Option for Patients with ALS

The FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with ALS, commonly referred to as Lou Gehrig’s disease.

U.S. Food and Drug Administration