1. Pink Sheet

VA's Aduhelm Restrictions: Big Symbolism But Small Impact?

 
• By Cathy Kelly

Biogen is ‘pleased’ access will be available through exceptions process in formulary restrictions though the US veterans agency does not expect there will be ‘significant’ interest among its clinicians in prescribing through that process. Price was not deciding factor, agency says.

VA Takes A Tough Stance On Covering Aduhelm

In another blow to the potential uptake of Biogen, Inc.’s and Eisai Co., Ltd.'s controversial new drug for Alzheimer’s disease, the US Department of Veterans Affairs has decided it will not cover Aduhelm on its centralized drug formulary or allow the manufacturers to promote the drug to VA clinicians because it has an unfavorable risk/benefit profile.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.