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Alzheimer’s Drug Coverage Issues Move To Forefront With Biogen’s Plan To Seek Approval

 
• By Cathy Kelly

Any product would be mostly covered by Medicare, but because the potential patient population will likely be 'substantial,' payers will likely 'closely scrutinize' these drugs, Duke Margolis white paper observes.

Alzheimers_Father_Son
The Value Of Alzheimer's Drugs Would Include Benefits Outside The Health Care System.

Biogen Inc.’s plan to seek US Food and Drug Administration approval for its aducanumab for Alzheimer’s disease is putting a spotlight on the many obstacles standing in the way of coverage and access for such treatments.

The company’s announcement last fall that it would seek approval for the anti-amyloid drug marked a reversal for Biogen, which...

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By Xu Hu

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.