Newsletter - June 16, 2022
Is FDA in a Bind with the Canadian Approval for the ALS drug?
This week Amylyx’s ALS drug was approved by the Canadian regulators raising speculations that this would make it very hard for FDA to reject this drug despite the negative vote by the FDA’s Advisory Committee which based its recommendation on the underwhelming clinical trial data from the one pivotal trial conducted by the company. Read More
FDA Releases an Updated List of Approved Drugs with No Generics
Since the infamous case of Daraprim price gouging in 2015 where a drug company bought the rights to a drug with no generics and raised the price by 5000% overnight due to its monopoly, FDA has been publishing a list of approved drugs with no patent protection and no generic versions to encourage the industr...Read More
Is FDA in a Bind with the Canadian Approval for the ALS drug?
This week Amylyx’s ALS drug was approved by the Canadian regulators raising speculations that this would make it very hard for FDA to reject this drug despite the negative vote by the FDA’s Advisory Committee which based its recommendation on the underwhelming clinical trial data from the one pivotal trial conducted by the company. Read More
FDA Releases an Updated List of Approved Drugs with No Generics
Since the infamous case of Daraprim price gouging in 2015 where a drug company bought the rights to a drug with no generics and raised the price by 5000% overnight due to its monopoly, FDA has been publishing a list of approved drugs with no patent protection and no generic versions to encourage the industr...Read More
