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
Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug. [Read more…] about First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease (Institute for Clinical and Economic Review):
The Institute for Clinical and Economic Review (ICER) believes that the FDA, in approving aducanumab (Aduhelm™, Biogen) for the treatment of Alzheimer’s disease, has failed in its responsibility to protect patients and families from unproven treatments with known harms. [Read more…] about Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen
Akili raises $110m to build its digital therapeutics pipeline (pharmaforum):
EndeavorRx became the first and so far only approved prescription video game treatment in the US when it was cleared by the FDA last year to treat attention-deficit hyperactivity disorder (ADHD), and has also been given a green light in Europe. [Read more…] about Akili Interactive Labs raises $160M in equity and debt to transform cognitive healthcare via prescription videogame treatments
The company has been pushing for more reimbursement of its three marketed DTx products in the US following a first FDA approval in 2017.
Pear said that the Ohio Department of Mental Health and Addiction Services (OhioMHAS) and RecoveryOhio are providing access to Pear’s FDA-approved DTx reSET and reSET‑O, for treatment of substance use disorder and opioid use disorders, respectively. [Read more…] about Ohio joins Indiana and Kentucky in funding Pear Therapeutics’ digital addiction treatments
AppliedVR Raises $29 Million for Immersive Headsets (LA Business Journal):
Century City-based AppliedVR, Inc. announced March 23 that it has raised $29 million in Series A funding that will be used to continue development of an immersive headset to help patients with chronic pain. [Read more…] about AppliedVR raises $29M to help make virtual reality the standard of care for treating chronic pain