While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when it comes to the treatment’s safety. [Read more…] about Study: Fewer than 1% of geriatric patients with cognitive complaints met Aduhelm research trial criteria. What can we expect about its real-world safety?
VA Health System Won’t Cover Biogen’s Alzheimer’s Drug (The Wall Street Journal):
The Department of Veterans Affairs won’t cover Biogen Inc.’s new Alzheimer’s drug, the latest rebuke of the controversial treatment since it was approved earlier this summer.
The VA decided not add the drug, called Aduhelm, to its formulary list of available medicines because of the drug’s risk of causing serious side effects and a lack of evidence that it improves cognitive function, an agency spokeswoman said. [Read more…] about Veterans Affairs won’t cover Biogen’s new “Alzheimer’s drug” given concerns over safety and lack of evidence
In the eyes of the tech industry, mental health treatment is an area ripe for disruption.
In any given year, 1 in 5 adults in the U.S. experience a form of mental illness, according to federal estimates. And research indicates only about half of them receive treatment in a system that is understaffed and ill distributed to meet demand.
For tech startups looking to cash in on unmet need, that translates into more than 50 million potential customers. [Read more…] about The explosion of mental health apps raises substantial opportunities–and tough questions
Pear Therapeutics to Go Public in Roughly $1.6 Billion SPAC Deal (The Wall Street Journal):
Medical technology company Pear Therapeutics Inc. has agreed to go public by merging with a blank-check company with ties to the Pritzker Vlock Family Office, betting on the growing role of prescription digital therapeutics.
The proposed merger would give the combined company a pro forma equity value of about $1.6 billion. [Read more…] about Prescription software firm Pear Therapeutics to go public via $1.6 billion SPAC deal, harnessing 3 FDA-authorized products and 14 candidates
The U.S. Food and Drug Administration (FDA) recently approved aducanumab, the first treatment that aims to slow the progression of Alzheimer’s disease. But approval of the drug has provoked mixed reactions from the scientific community.
Alzheimer’s disease is characterized by progressive memory loss, spatial disorientation and many other cognitive and behavioural disorders that ultimately lead to a state of total dependence. [Read more…] about Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer’s treatments? (Yes, it can)
Senator Joe Manchin, a moderate Democrat considered a crucial vote within the party’s slim Senate majority, said Janet Woodcock, the temporary head of the Food and Drug Administration, should be quickly replaced with a permanent leader.
Manchin blasted an FDA decision to approve the controversial Alzheimer’s therapy Aduhelm despite conflicting evidence that the Biogen Inc. drug works and an overwhelmingly negative vote against the therapy by agency advisers. The FDA ruling led three members of that panel to quit in protest… [Read more…] about US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab