Singes morts à cause des implants Neuralink : Elon Musk aurait menti .
Alors que l’entreprise recherche des patients humains pour tester sa technologie, une enquête dévoile le sort peu enviable des animaux cobayes.
For decades, the Kochs have held deep antipathy to govt #regulation. When Charles #Koch’s brother David ran for VP on the #Libertarian Party ticket in 1980, the party platform called for abolishing the #EPA, the #DOE & the #FDA.
Every winter, the network holds its marquee #fundraising event in Coachella Valley in SoCal. Hundreds of #donors fly in to learn how their money is being spent & plan for the coming yr. Fmr staffers describe an emphasis on preventing #leaks that bordered on obsession.
A start-up biotechnology company says it received the okay for its investigational new drug application of an anti-viral drug to treat a whole class of seasonal flu strains.
AstraZeneca refused to pay full bonus to US remote worker, lawsuit claims -- Third time might be the charm for Alvotech's Humira biosimilar -- Roche scores—again—in hemophilia drug patent case against Takeda -- See more on our front page news http://bit.ly/w28kSd #astrazeneca #remotework #legal #employmentlaw #alovtech #humira #abbvie #fda #biosimilars #roche #genenetech #takeda #patents #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
Musk’s Neuralink to Start Testing Brain Implants in Humans
#Neuralink #BrainImplants #ParalysisAid #ElonMusk #BCI #HumanTrials #TechInnovation #MedicalBreakthrough #FDA #Neuroscience #Healthcare #AnimalTrials #RegulatoryApproval #HumanTrials #Microchips
Eli Lilly launched a suit,
Against some US medical louts,
They tried to sell a pill,
Dubbed "Mounjaro" with a thrill,
'Twas not FDA approved, that's the doubt,
The spas, wellness centers and pharmacies,
Must answer for these wrong answers, please!
Please join us next Wednesday (9.27) for a seminar by Dr. Jennifer Clark (lead mathematical statistician in the Office of Biostatistics at the FDA’s Center for Drug Evaluation and Research) discussing biostatistics at the FDA. The presentation will be held at 2525 West End Avenue (11th floor) and available online. Contact Cierra.Streeter[at]vumc.org for access. #biostatistics #FDA
...Animal 15 began to lose coordination and staff observed that she would shake uncontrollably when she saw lab workers. Her condition deteriorated for months until the staff finally euthanized her. A necropsy report indicates that she had bleeding in her brain and that the Neuralink implants left parts of her cerebral cortex “focally tattered.”...
Amgen-Horizon merger clearance a setback to FTC's antitrust enforcement plans -- Genentech sees more potential in peptides, signs $1B biobucks deal with PeptiDream -- FDA rejects nasal spray for severe allergic reactions -- See more on our front page news http://bit.ly/w28kSd #amgen #ftc #antitrust #mergersandacquisitions #genentech #peptides #biobucks #fda #allergicreactions #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma
In #ISOQOL-s most recent #QualityTALK, a team argues that while such a modular approach has advantages, it complicates the decision of choosing a PROM. The selection should take account of the overall trial objectives and context (e.g., see #ISOQOL, #SPIRITPRO, #SISAQOL) and involve all relevant stakeholders.
Link to ISOQOL's perspective: https://www.isoqol.org/wp-content/uploads/2023/07/ISOQOL-R_HE-SIG-Comments-on-PFDD-Draft-Guidance-4_Final.pdf
and a commentary presenting the position:
The bill will become law once it is signed by the governor of California, Gavin Newsom, having passed all the legislative stages. It is the first bill of its kind and once enacted, it marks the first time a US state has banned food additives that are permitted by the #FDA.
Proponents of the legislation hope other US states will follow suit by implementing similar bans, prompting a nationwide transition to safer alternatives.
“I will not stand by & let the #FDA & #CDC use healthy Floridians as guinea pigs for new #booster shots that have not been proven to be safe or effective,” said the “governor” in a written statement released after his “surgeon general” urged people under 65 not to get the booster. #DeSantis reiterated that position the next day on the talk show of Iowa-based commentator Steve Deace, saying fed #health authorities have been “corrupted by ideology.”
Toddler poisoned after eating deadly plant mislabeled as diet supplement - Enlarge / Yellow oleander. (credit: Getty | FlowerPhotos)
Ars Technica: The spectacular downfall of a common, useless cold medicine https://arstechnica.com/?p=1968612 #Tech #arstechnica #IT #Technology #advisorycommittee #over-the-counter #allergymedicine #phenylephrine #coldmedicine #drugefficacy #efficacy #mucinex #sudafed #Health #nyquil #merck #CHPA #fda
The spectacular downfall of a common, useless cold medicine - Enlarge / A box of Sudafed PE sinus pressure and pain medicine containi... - https://arstechnica.com/?p=1968612 #advisorycommittee #over-the-counter #allergymedicine #phenylephrine #coldmedicine #drugefficacy #efficacy #mucinex #sudafed #health #nyquil #merck #chpa #fda
If it doesn't work then it should be banned.
Brighteon Broadcast News, Sep 14, 2023 - Shocking science paper explains how 5G cell signals can unleash KILL VECTOR PAYLOADS in the human body
- #Ukraine destroys Russian submarine in cruise missile attack on Sevastopol dry dock
- #Russia likely to retaliate... is "Sea Breeze" naval op in the #BlackSea a BAIT provocation?
- NY Gov. Hochul tells everyone who took covid jabs, those won't work anymore, suckas!
- #FDA and #pharma are pushing a "whole new vaccine" with zero testing or clinical trials
- Bombshell story: Cell phone signals can remotely activate graphene oxide PAYLOADS in the human body
- 5G cell towers can, indeed, act as "kill vector" weapon systems
- #Vaccines can be used to inoculate people with graphene oxide containing toxic payloads
- Full interview with Jim Shepherd, founder of Berkey water company, on EPA abuse
Florida Man sez don't get vaccinated...
Florida surgeon general rejects #FDA guidance, urges people under 65 not to get #Covid booster
The owner of the restaurant, however, said that they have all the licences, except FSSAI, which is underway.
#PopularKebabJointBademiyaShut #FDA #Cockroaches #Kitchen
💊 O FDA norte-americano concluiu que a fenilefrina é tão boa quanto um placebo para descongestão nasal quando uma pessoa está com gripe ou resfriado. Ou seja, não serve pra isso quando usada por via oral.
Desde os anos 2000 esse fármaco é usado nos EUA em remédios para gripe e representa uma indústria de US$ 1,8 bilhão por ano.
No Brasil, medicamentos como Cimegripe, Neolefrin e MultiGripe usam cloridrato de fenilefrina.
A Anvisa ainda não se pronunciou sobre o caso para produtos vendidos aqui.
Bring back phenylpropanolamine, you cowards. #phenylephrine #fda
Is it possible that Mastodon cherry picked what one person on ACIP said ???
The new #COVID shots are expected to take aim at circulating strains, including the EG.5, or Eris, strain, which the #CDC said accounted for 21.5% of cases as of Sept. 2, as well as a newer variant, FL.1.5.1, dubbed Fornax, which accounted for 14.5% of U.S. infections.
Really interesting discussion on using #rstats for #fda submission from #NovoNordisk. Great to learn about their first submission with R code. https://www.youtube.com/live/t33dS17QHuA?si=s4u3p6QeC8HU-iHM
"Vaccination against #COVID19 remains the most important protection in avoiding hospitalization, long-term health complications & death. I encourage all Americans to stay up-to-date on their vaccines." - @POTUS Biden
https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/12/statement-from-president-biden-on-fda-and-cdc-actions-on-updated-covid-19-vaccines/ #SARSCoV2 #GetBoosted #FDA #CDC #ACIP💉😷💉
Decongestant ingredient in popular products does not work, #FDA concludes
Advisory panel reviewed studies of #phenylephrine, an active ingredient in #Benadryl, #Mucinex, #Sudafed PE and #Tylenol
A new company developing treatments for neurological and psychiatric diseases from aberrant immune system activity is raising $58 million in seed funds.
At issue is phenylephrine, an almost-century-old ingredient in versions of Benadryl, Mucinex, Tylenol and other over-the-counter pills, syrups and liquids to clear up congested noses.”
- The Wall Street Journal https://apple.news/A0v6rsr0eQSi20SYLIdoRIg
US regulator approves vaccines for latest COVID strains
Updated COVID boosters get green light from FDA ahead of CDC review - Enlarge / The Food and Drug Administration headquarters in White Oak, M... - https://arstechnica.com/?p=1967187 #pfizer/biontech #mrnavaccine #sars-cov-2 #boosters #covid-19 #fallshot #vaccines #science #moderna #novavax #omicron #health #pfizer #cdc #fda
📢 R Consortium Pilot 3 Milestone 📢
Big news! R Submissions Working Group successfully submitted the pilot 3 R-based package to FDA eCTD on August 28, 2023. This is the first public R-centric FDA submission!
-5y+ regardless of previous 💉 are eligible to receive a single dose of an updated #mRNA #COVID #vaccine at least 2mo since last dose
-6mo to 4y prev vaccinated can receive 1-2 updated 💉
-Unvaxxed 6m-4y can get 3 doses of updated 💉
#FDA approves a new round of #COVID19 booster vaccines. https://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
YES! 💉😷 “#FDA gave the green light to updated #Covid-19 #vaccine booster shots from #Moderna and #Pfizer/BioNTech. The updated vaccines are each approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old. As part of the FDA’s update, the original bivalent Moderna and Pfizer-BioNTech Covid-19 vaccines are no longer authorized for use in the US” 1/...
#FDA approves new #covid19 vaccines, still needs #CDC ruling for deployment https://www.cnbc.com/2023/09/11/covid-vaccines-fda-approves-new-shots-from-pfizer-moderna.html
#TIL that there is a real product called "Not Fried Chicken ice cream," the slogan is "weaponized mouth joy," and it is being recalled for possible Listeria monocytogenes contamination: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/life-raft-treats-recalls-ice-cream-products-not-fried-chicken-and-life-peachy-due-possible-listeria #FDA #foodSafety
There's some clown at the #FDA saying the latest #COVID-19 booster is intended only for the immunocompromised and people over 75. Submit a comment to the #CDC today: We ALL need access to boosters. https://peoplescdc.substack.com/p/tell-the-cdc-all-ages-need-updated?utm_medium=web&fbclid=IwAR1qKJS3Pn2X-YaP4EdfDMv_hVpguINtCDSXaPIxLskRuVeKHx04ano56ew
@US_FDA is about to authorize the #COVID variant (BA.2.86) booster shot, next week.
@CDCgov is pondering whether to RESTRICT booster to some ages, 75+ initially.
You CAN tell them NOT to have their head shoved up their ass, and allow EVERYONE to take it by voicing your opinion, here.
This leaves liberals in the increasingly absurd position of defending the indefensible: insisting that the #FDA shouldn't be questioned despite its ghastly failures during the #opioid epidemic; claiming that the #VotingMachine companies whose defective products have been the source of increasingly urgent technical criticism are without flaw.
Make it make sense. On one hand, when it comes to medications that chemically induce early term #abortions, we are not supposed to take them because the #FDA didn't test them enough. But on the other hand, we have this. We cannot bar doctors for prescribing #ivermectin for COVID because it was never tested on that virus at all.
@bicmay I don't do the NYT paywall, so this article is off limits. Having said that, the #FDA has a great place to check if #COVID19 rapid tests have extended expiration dates. Many have and still work.
Covid-19 cases continue to climb.
As a result, the #FDA is reportedly planning to ok release of this year's updated vaccine for mid- instead of late-September. Yeah!
The #CDC Advisory Committee on Immunization Practices is meeting on Sept. 12.
Frozen vegetables recalled for possible listeria contamination
The brands are Food Lion, Signature but mostly Kroger's.
⚠️ #FDA warns of possible contamination of Dr. Berne's, LightEyez eye drops - UPI.com
CDC, pharmacies try to speed up Covid vaccine program for the uninsured
Biden health officials are attempting to finalize contracts that would allow pharmacies to offer a Covid jab to uninsured Americans as early as mid-September, when the government plans to make an updated version of the life-saving vaccine available to the broader public.
https://www.politico.com/news/2023/08/21/pharmacy-covid-vaccine-uninsured-00112147 #CVS #Walgreens #FDA #health #healthcare #Pfizer #BioNTech #Moderna #Novavax #Covid19 #coronavirus #MRNA #HHS #Insurance
US approves consumption and sale of “cell-cultivated chicken” — MercoPress
>The U.S. Department of Agriculture is revolutionizing the meat industry, it has approved the sale of cell-cultured chicken in a landmark decision that clears the path for consumers to try it out themselves, the two startups that received the first approvals announced.
https://en.mercopress.com/2023/08/17/us-approves-consumption-and-sale-of-cell-cultivated-chicken #FrankenFood #US #FDA #labmeat
"It felt like the Hunger Games":
What a gut punch ending.
While public #health officials are urging #Americans to stay up to date with #vaccinations, the #Wisconsin #Senator #RonJohnson and #FoxNews personality Maria #Bartiromo falsely refuted #vaccine efficacy and safety while wrongly stating that #ivermectin is an #FDA-approved treatment.
The Food and Drug Administration has issued an urgent recall for a set of pregnancy and ovulation tests the agency said it can no longer guarantee are safe.
Manufacturer Universal Meditech has stopped supporting the tests, the FDA said, bringing their reliability and safety into question.
The company issued its own recall for remaining stock at distributors, but not for those already sold.
New SARS-CoV-2 variant gains dominance in US amid mild summer COVID wave - Enlarge (credit: Getty | Thomas Trutschel)
For a fourth consec... - https://arstechnica.com/?p=1959483 #hospitalizations #testpositivity #seasonality #sars-cov-2 #subvariant #wastewater #covid-19 #pandemic #vaccines #omicron #health #deaths #summer #cdc #fda
#5yrsago Chicago’s ‘#AlohaPoke Co’ wants Hawaiians to stop using the words ‘aloha’ and ‘poke’ https://www.washingtonpost.com/news/food/wp/2018/07/30/a-midwestern-chain-told-hawaiians-to-stop-using-aloha-with-poke-igniting-a-heated-debate
#5yrsago #Koch thinktank inadvertently proves that America would save trillions by switching to #SocializedMedicine https://www.commondreams.org/news/2018/07/30/koch-funded-hit-piece-backfires-shows-medicare-all-would-save-whopping-2-trillion
#5yrsago #FDA warns companies: stop selling quack “#VaginalRejuvenation,” adds, “People, please don’t do this to yourselves” https://arstechnica.com/science/2018/07/dont-try-to-rejuvenate-your-vagina-the-fda-warns-after-scolding-companies/
FDA approves nonprofit's over-the-counter opioid overdose nasal spray used to reverse opioid overdose
But unlike other opioid overdose products, the 3 milligram treatment will be available for free or low cost, and its sales will bring no profit to its manufacturer
The U.S. Food and Drug Administration issued new regulatory guidance for clinical trials of medical devices designed to prevent or treat opioid use disorder.
A treatment for HIV taken just once, using the genome-editing technology Crispr, is receiving fast-track designation from the U.S. Food and Drug Administration.
“Nirsevimab, which will be sold under the brand name Beyfortus, is not a vaccine. Vaccines prompt the body to make antibodies to defend against pathogens. Instead, nirsevimab is a form of passive immunity. It’s a ready-made antibody that can bind to the virus and block it from infecting healthy cells. The immune system doesn’t have to make anything.” #health
#FDA approves a birth control pill to be sold without a prescription for the first time in the US. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. #FDA #WomensHealthcare
U.S. officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops.
The AP reports the "FDA’s decision has no relation to the ongoing court battles over the abortion pill mifepristone."
Novavax Fall 2023 Vaccine Booster Update
#Novavax presented at the June 15th #FDA #VRBPAC meeting to provide neutralization results from testing with various combinations of the original #vaccine, #BA.5, #XBB.1.5 and #XBB.1.16 #boosters. This thread will highlight the presentation. 🧵 1/
An unrolled one-page web view for this long thread that may be easier to read or share can be found here ( https://twitter.com/jeffgilchrist/status/1678356489449140226 )
“#FDA has approved blood test that can identify pregnant women who are at imminent risk of developing a severe form of high blood pressure called pre-eclampsia, a leading cause of disability and death among childbearing women.
AP: Thousands of unauthorized #vapes are pouring into the US despite the #FDA crackdown on fruity flavors. https://apnews.com/article/80b2680a874d89b8d651c5e909e39e8f
Oh good, FDA is banning ElfBar disposable vapes. Children poisoned.
Since gun accidents are the leading cause of death of children in the US, and opioids are the leading cause of poison fatalities in children, surely these are also getting banned? Regulated? A little? No?
I hate everything at the moment.
Scores of Critical Lab Tests Fall Into a Regulatory Void. The #FDA Is Trying to Close It.
Lab-developed tests like #prenatal screenings have become increasingly popular, all while escaping the bulk of federal scrutiny over #marketing and accuracy. Now, the FDA is beginning the process of imposing regulations on these kinds of tests.
Skolnick is a physicist by training, but has a long history of collaboration with #OpenBiome, a nonprofit that coordinates between doctors, patients and donors to provide safe FMTs:
In a Dec '22 Eat Shit post, Skolnick recounts the amazing history and dismaying future of FMTs. In 2013, the #FDA announced it would regulate FMTs as "Investigational New Drugs," which could only be administered through a registered clinical trial: