Food and Drug Administration (FDA) Blogs This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

The FDA was wrong about Aduhelm
The Food and Drug Administration (FDA) negated the recommendation of its expert panel and approved Aduhelm to treat Alzheimer ’s dementia (AD), contending that the possible benefit trumped the lack of evidence of efficacy. The FDA was inexcusably in error in making this decision. Aside from the likely lack of benefit, the use of this drugRead more …Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - July 8, 2021 Category: General Medicine Authors: < span itemprop="author" > < a href="https://www.kevinmd.com/blog/post-author/m-bennet-broner" rel="tag" > M. Bennet Broner, PhD < /a > < /span > Tags: Meds Medications Neurology Source Type: blogs

Arizona Lawmakers Underperform on Pharmaceutical Freedom for Women
Jeffrey A. SingerMy home and surgical practice are in Phoenix, Arizona. One hundred eighty miles to the west of Phoenix, a women can walk into aCalifornia pharmacy and ask the pharmacist to prescribe her hormonal contraceptives, bypassing the doctor ’s office and the $100+ fee for an office visit (and possibly an afternoon off from work). Drive 248 miles due east and a woman can get a prescription for hormonal contraceptives from a pharmacist inNew Mexico. Three hundred miles to the north, and 373 miles to the northeast, pharmacists can prescribe hormonal contraceptives to women inUtah andColorado respectively. And if a ...
Source: Cato-at-liberty - July 6, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Update on the aducanumab (Aduhelm) saga, retirement, financial advice, cognitive health, excessive worrying, neurotech, and more
Welcome to a new edition of SharpBrains’ e‑newsletter, providing this time a summary of the saga around the FDA approval of aducanumab (Aduhelm) as a supposed treatment for Alzheimer’s Disease, plus a range of timely research findings and resources for lifelong brain health. First, below are some key reads to navigate “probably the worst drug approval decision in recent U.S. history” — Dr. Aaron Kesselheim, the Professor of Medicine at Harvard Medical School who resigned rom the FDA Advisory Committee in protest. #1. Growing backlash against the FDA approval of unproven Alzheimer’s tr...
Source: SharpBrains - June 30, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Education & Lifelong Learning SharpBrains Monthly eNewsletter Technology & Innovation aducanumab Aduhelm Alzheimers-disease anti-amyloid drug Biogen Brain Teasers brain-teaser cognitive decline cognitive-exerci Source Type: blogs

Politics, Science, and Money: The Collective Meltdown Over the New Alzheimer ’s Drug
Jeffrey A. SingerOn June 22, theWall Street Journalpublished aneditorial defending the Food and Drug Administration ’s accelerated approval of the controversial new Alzheimer’s drugAduhelm. The drug has been shown to reduce the amyloid plaque that develops in the brains of Alzheimer ’s patients. However, researchers areunsure if the plaque is a cause or an effect of Alzheimer ’s disease, and if reducing the plaque will have any clinical benefit. Critics of the FDA decision claim that clinical trials have failed to produce convincing evidence that the drug does any good.In a recentblogpost I argued th...
Source: Cato-at-liberty - June 29, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

The explosion of mental health apps raises substantial opportunities –and tough questions
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. Venture capital firms invested more than $2.4 billion in digital behavioral health apps in 2020 — more than twice the amount invested in 2019 — touting support or treatment ...
Source: SharpBrains - June 28, 2021 Category: Neuroscience Authors: Kaiser Health News Tags: Brain/ Mental Health Technology & Innovation anxiety BetterHelp brain-illness Brightside cerebral depression digital behavioral health FDA Food and Drug Administration Ginger health apps mental illness mental-health-treatment Source Type: blogs

Prescription software firm Pear Therapeutics to go public via $1.6 billion SPAC deal, harnessing 3 FDA-authorized products and 14 candidates
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. Boston-based Pear Therapeutics is merging with Thimble Point Acquisition Corp. in a deal that’s expected to close in the second half of the year, subject to Thimble Point shareholder approval. Investors that inc...
Source: SharpBrains - June 23, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Technology & Innovation digital therapeutics FDA Food and Drug Administration Neuberger Berman Group patient retention PEAR Pear Holdings Corp Pear Therapeutics prescription digital therapeutics prescription soft Source Type: blogs

Can the controversial FDA approval of Aduhelm backfire and delay the discovery of actual Alzheimer ’s treatments? (Yes, it can)
This article was originally published on The Conversation. News in Context: 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 First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen A critical appraisal of amyloid-B-targeting therapies for Alzheimer disease The post Can the controversial FDA approval of Aduhelm backfire and...
Source: SharpBrains - June 21, 2021 Category: Neuroscience Authors: The Conversation Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer's biomarkers Alzheimer's drug Alzheimers-disease amyloid Biogen clinical-trials FDA FDA drug approval process tau Source Type: blogs

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
Key Democrat Manchin Bashes FDA Leader on Alzheimer’s Approval (Bloomberg): 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… Manchin urged U....
Source: SharpBrains - June 18, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer's treatments Alzheimer’s therapy Alzheimers-disease Biogen FDA Food and Drug Administration Joe Manchin opioids OxyContin public-health Source Type: blogs

First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News): 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. I am not a casual bystander to this controversial decision. I am a physician who has been treating people with Alzheimer’s since 1982; an early researcher into the biology of amyloid, the brain protein that Aduhelm targets; someone with a strong personal family history of dementia … As I ...
Source: SharpBrains - June 16, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Aduhelm amyloid anti-amyloid dementia FDA Food and Drug Administration neurological drugs Source Type: blogs

Why “Radiopharmaceutical” Should be Part of your Healthcare Vocabulary
By JAY T. RIPTON Not to sound too alarmist, but the radiopharmaceutical industry is on the verge of an explosion. But don’t worry; it’s not the type of explosion one often associates with nuclear materials… I love those movies too! It’s the beginning of a new wave of innovation for the diagnosis and treatment of certain cancers and other diseases. This new radiopharmaceutical boom quite literally has the life sciences industry in a nuclear arms race of sorts, as companies like Y-mAbs, Novartis and others are pushing through clinical trials for the next blockbuster for the treatment and detection of hard-t...
Source: The Health Care Blog - June 14, 2021 Category: Consumer Health News Authors: Christina Liu Tags: Medical Practice jay t ripton nuclear medicine radiation oncology radiopharmaceuticals Source Type: blogs

Growing backlash against the FDA approval of unproven Alzheimer ’s treatment Aduhelm, by Biogen
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. Our review of the evidence was concordant with that of many independent experts: current evidence is insufficient to demonstrate that aducanumab benefits patients. The avenue forward has seemed clear: another study would be...
Source: SharpBrains - June 14, 2021 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer’s Disease Alzheimer’s disease treatment amyloid amyloid plaques amyloid-related imaging abnormalities ARIA Biogen brain swelling clinical benefit FDA ICER Janet Woodcock N Source Type: blogs

The Supreme Court's Abortion Exceptionalism
Dov Fox (University of San Diego), Erin Cole (University of San Diego), The Supreme Court's Abortion Exceptionalism, 384 N.E. J. of Med. (2021): On April 12, 2021, the Food and Drug Administration (FDA) temporarily lifted its decades-long restriction on access... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - June 3, 2021 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

Have Lawmakers Forgotten The Pandemic ’s Lessons Already?
Jeffrey A. SingerSome lawmakers seem to suffer from long ‐term memory loss. This can beworrisome—both for them and for the country. It seems like only yesterday (it was March 2020) when New York Governor Andrew Cuomo complained about the cumbersome Food and Drug Administration approval process for COVID-19 tests,pleading with federal regulators to permit the state ’sWadsworth Laboratory and private labs to perform laboratory developed tests (LDTs) without waiting for a green light from the FDA. At the time the U.S. laggedembarrassingly behind South Korea and other Asian and European countries in testing its p...
Source: Cato-at-liberty - May 12, 2021 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Fight Aging! Newsletter, May 3rd 2021
Fight Aging! publishes news and commentary relevant to the goal of ending all age-related disease, to be achieved by bringing the mechanisms of aging under the control of modern medicine. This weekly newsletter is sent to thousands of interested subscribers. To subscribe or unsubscribe from the newsletter, please visit: https://www.fightaging.org/newsletter/ Longevity Industry Consulting Services Reason, the founder of Fight Aging! and Repair Biotechnologies, offers strategic consulting services to investors, entrepreneurs, and others interested in the longevity industry and its complexities. To find out m...
Source: Fight Aging! - May 2, 2021 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs

A Small Human Study of Short Term Nicotinamide Mononucleotide Supplementation
Declining levels of NAD+ in cells is one of the proximate causes of loss of mitochondrial function with age. A number of approaches to increasing levels of NAD+ in cells involve using supplements that are derived from vitamin B3. Nicotinamide mononucleotide (NMN) is one of these, but has to date far less published human evidence for its effects than is the case for nicotinamide riboside (NR), making the small study noted here interesting. In general, the evidence for vitamin B3 derived compounds to increase NAD+ in older people is good, while the evidence for that increase to then produce benefits to health is mixed at bes...
Source: Fight Aging! - April 29, 2021 Category: Research Authors: Reason Tags: Daily News Source Type: blogs