ProMIS Neurosciences Inc PMN

SOME Biogen chatter

[retiredcop]

Biogen investors expect company to win approval for Alzheimer’s drug: RBC survey
May 25, 2021 1:05 PM ETBiogen Inc. (BIIB)By: Dulan Lokuwithana, SA News Editor10 Comments

• A majority of Biogen (BIIB -1.8%) investors predict the company to win the FDA approval for experimental Alzheimer’s disease therapy aducanumab albeit with restrictions, according to a survey conducted by RBC Capital Markets.
• With restrictive monitoring requirements, the FDA approval will narrow its use to a select group of patients, most of the respondents in the survey have indicated.
• Rejection of approval could lead to a 30% drop in Biogen shares, 40% of the respondents have said in the study that involved 47 mainly specialist investors.
• Full approval and conditional approval will add 50% and 20%, respectively, wrote analyst Brian Abrahams citing the survey.
• In January, the FDA extended the review period of the Biologics License Application (BLA) filed by Biogen and Eisai Co. (OTCPK:ESALF) for aducanumab by three months making June 07 the new PDUFA

 
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https://www.fiercepharma.com/pharma/biogen-s-swiss-based-plant-receives-regulatory-nod-as-agency-readies-launch-for-alzheimer-s

Biogen's $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab

by Noah Higgins-Dunn | 
May 25, 2021 11:05am
Despite a flurry of uncertainty surrounding Biogen’s Alzheimer's hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the drug score an approval.
Switzerland’s medicines surveillance authority, the Swiss Agency for Therapeutic Products (Swissmedic), issued Biogen's Solothurn manufacturing facility a Good Manufacturing Practice (GMP) license, the company said.

[retiredcop]

A hugely consequential decision:' How Biogen's Alzheimer's drug came to face the FDA By June 7, the regulator will decide on whether to approve aducanumab, a decision that could have far-reaching consequences for patients, Biogen and Alzheimer's research. Published May 27, 2021   https://www.biopharmadive.com/news/biogen-aducanumab-alzheimers-fda-drug-review/600897/

[M101]

lol, chatter=hyperbole, more paid content for corporate welfare   "By June 7, Biogen's bet-the-company decision will either pay off in spectacular fashion with a landmark clearance or go bust..."

[retiredcop]

As FDA decides on Biogen drug for Alzheimer’s, patients and families hold out hope By Jonathan Saltzman Globe Staff,Updated June 2, 2021, 52 minutes ago   Within days, federal regulators will decide whether to approve the first new drug for Alzheimer’s disease in nearly two decades, a controversial medicine from Cambridge-based Biogen that seems to have as many detractors as proponents