(WASHINGTON) FDA REPORT: Approval of the first drug for ‘Alzheimer’s Disease’ in 20yrs that shows substantial evidence that it reducesamyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients #AceHealthDesk report

#AceNewsReport – June.09: Aducanumab targets the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms:

US approves first new Alzheimer’s drug in 20 years: The US Food and Drug Administration (FDA) said there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients”

Aldo Ceresa, who took part in the trial, says he’s “heading in the right direction”

Charities have welcomed the news of a new therapy for the condition.

But scientists are divided over its potential impact because of uncertainty over the trial results.

At least 100,000 people in the UK with a mild form of the disease could be suitable for the drug if it were to be approved by the UK regulator. 

Controversial trial

In March 2019, late-stage international trials of aducanumab, involving about 3,000 patients, were halted when analysis showed the drug, given as a monthly infusion, was not better at slowing the deterioration of memory and thinking problems than a dummy drug.

But later that year, the US manufacturer Biogen analysed more data and concluded the drug did work, as long as it was given in higher doses. The company also said it significantly slowed cognitive decline.

Aducanumab targets amyloid, a protein that forms abnormal clumps in the brains of people with Alzheimer’s that can damage cells and trigger dementia, including:

  • memory and thinking problems
  • communication issues 
  • confusion

‘Heading in right direction’

Aldo was one of just a handful of UK patients in the trial

Aldo Ceresa, who took part in the trial, first noticed problems differentiating between left and right 10 years ago.

After his diagnosis, the 68-year-old, who is originally from Glasgow and now lives in Oxfordshire, close to his family, had to give up his job as a surgeon. 

Mr Ceresa took aducanumab for two years before the trial was halted – and then had to wait almost as long for another trial, at the National Hospital for Neurology and Neurosurgery, in London, to begin.

“I’m quite happy to volunteer,” he says.

“I really, really enjoy this journey that I’m going through – and obviously the benefits I’m getting from it, which I’m very, very grateful for.”

He is convinced the drug has helped him.

“I feel like I’m not quite as confused. Although it’s still there, it’s not quite as bad. 

“And I’m just getting that bit more confident now.”

Mr Ceresa says his family has noticed improvements too.

“Before, if I was going to get something, I couldn’t remember, you know, where to find things in the kitchen. 

“That has become less of a problem,” he says.

“I haven’t caught up to the level that I was before – but I’m heading in the right direction.”Aldo’s brain was scanned regularly to see the effects of aducanumab

More than 30 million people around the world are thought to have Alzheimer’s, with most aged over 65.

For around 500,000 people affected in the UK, those eligible for aducanumab will be mostly in their 60s or 70s and at an early stage of the disease.

‘Very cautious celebration’

We need to keep our feet on the ground. 

This is not a miracle drug, nor a cure for Alzheimer’s but it is the first treatment which tackles the destructive mechanism in the brain that drives the destruction of neurons.

And that makes this a landmark moment.

But scientific opinion both here and the United States is divided. While some have welcomed approval, calling it a milestone for millions living with Alzheimer’s, others believe the drug will only have marginal benefits. 

Alzheimer’s charities say they will be pressing for an early decision in the UK – but that could take another year.

Lastly, we don’t know how much aducanumab will cost – it could be tens of thousands of pounds per patient each year. And if approved, access will be limited to those who’ve had specialist brain scans to confirm their diagnosis.

Despite all the caveats, this is moment for very cautious celebration. 

Prof Bart De Strooper, director of the UK Dementia Research Institute, said the decision to approve aducanumab marked “a hugely significant milestone” in the search for treatments for Alzheimer’s disease.

In the past decade, more than 100 potential Alzheimer’s treatments have flopped. 

But while he hoped it would prove a turning point for millions of people with the condition, he said there were “still many barriers to overcome”. 

Prof John Hardy, professor of neuroscience at University College London, said: “We have to be clear that, at best, this is a drug with marginal benefit which will help only very carefully selected patients.”

‘Grave error’

And Prof Robert Howard, professor of old age psychiatry at UCL, went further calling the drug’s approval “a grave error” that could derail the ongoing search for meaningful dementia treatments “for a decade”. 

He said the FDA had ignored data from the trial which showed no slowing of decline in cognition or function.

However, Alzheimer’s Society said the drug was “promising” but added it was “just the beginning of the road to new treatments for Alzheimer’s disease”.

Another charity, Alzheimer’s Research UK, said it had written to the Health Secretary Matt Hancock asking the government to prioritise the fast-track approval process for the drug in the UK.

Chief executive Hilary Evans, said: “People with dementia and their families have been waiting far too long for life-changing new treatments: It is now essential that regulatory authorities assess the evidence to decide whether they believe the drug is safe and effective for use in the UK.” Although many doctors are doubtful of aducanumab’s benefits, its US approval could be a huge boost to dementia research, which is traditionally underfunded compared with cancer or heart disease.Aldo has a magnetic-resonance-imaging (MRI) scan

The BBC is not responsible for the content of external sites.

#AceHealthdesk report ….Published: Jun.09: 2021:

Editor says #AceNewsDesk reports by https://t.me/acenewsdaily and all our posts, also links can be found at here for Twitter and Live Feeds https://acenewsroom.wordpress.com/ and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#alzheimers-disease, #fda, #ucl, #washington

(WASHINGTON) Press Release FDA Statement Report: US Drugs regulator speeds up out put of #COVID19 vaccine with larger vials containing 15-doses #AceHealthDesk report

#AceHealthReport – Apr.02: Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said.

#CoronavirusNewsDesk – Moderna gets nod to speed up virus vaccine output with bigger vials: In a statement, Moderna said its vaccine can now can be supplied in vials containing 11 or 15 doses, and it expected to begin shipping 15-dose vials in coming weeks: The U.S. Food and Drug Administration (FDA) also authorized vaccinators to extract a maximum of 11 doses from the current vials, instead of the ten previously permitted.

However, the regulator also warned that without proper syringes and needles it may not be possible to extract more that 13 doses from Moderna’s 15 dose vials, and more than 10 doses from the current vials.

Moderna has supplied 100 million doses of its vaccine to the United States as of March 29. Pfizer/BioNTech and Johnson & Johnson’s shots are the other two vaccines approved in the country.

With rising cases and several states even lifting mask mandates and with more infectious variants also spreading, health authorities are hoping that the contracts it struck with the currently approved vaccine makers will be enough for its entire population.

U.S. top infectious diseases doctor Anthony Fauci told Reuters on Thursday that the country may not need AstraZeneca’s COVID-19 vaccine even if it wins U.S. regulatory approval.

Reporting by Radhika Anilkumar and Shubham Kalia in Bengaluru; editing by Uttaresh.V & Simon Cameron-Moore

#AceHealthDesk report ……..Published: Apr.02: 2021:

Editor says #AceNewsDesk reports by https://t.me/acenewsdaily and all our posts, also links can be found at here for Twitter and Live Feeds https://acenewsroom.wordpress.com/ and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#covid19-coronavirusnewsdesk, #fda, #vaccines, #washington

WASHINGTON: ‘ FDA Top Official Under-Fire to Resign Over Drug Abuse Scandal ‘

#AceWorldNews – WASHINGTON – September 24 – Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency’s policies have contributed to a national epidemic of prescription painkiller abuse.

' Zohydro FDA Approved Against Medical Advice '

‘ Zohydro FDA Approved Against Medical Advice ‘

In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009.

The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro against the recommendation of its own medical advisers.

#ANS2014

#fda, #obama, #washington, #zohydro

‘ Toxic Practise FDA Allows Despite Health Risks ‘

#AceNewsServices – September 21 – This toxic practice makes seriously decayed meat look fresh for weeks and is banned in many countries including the European Union and Japan.

' Toxic Meat Being Sold As Fresh '

‘ Toxic Meat Being Sold As Fresh ‘

Many consumers are unaware that over 70% of beef and chicken in the United States and Canada is treated with poisonous carbon monoxide gas and the FDA allows it, despite the known public health risks.

A bill was introduced in Congress that would require the labelling of meat that has been treated with carbon monoxide but it was never enacted and the topic was swept under the rug entirely. [Bill: H.R. 3115 (110th) introduced on July 19, 2007; never enacted.]

This practice makes meat appear and smell fresh even when contaminated with harmful bacteria such as Clostridium botulinum, Salmonella, Campylobacter, and E-coli 0157:H7.

Carbon monoxide makes meat appear fresher than it really is by reacting with the meat pigment myoglobin to create carboxymyoglobin.

This bright red pigment masks the natural tell tale signs of spoiled meat such as rank odours and slime.

Meats containing carboxymyoglobin will appear red and fresh for days or even weeks beyond the point of spoiling.

Read More:Source: 

#ANS2014

#congress, #fda, #united-nations, #united-states

‘ FDA New Rules for Prevention of Food Contamination ‘

#AceNewsServices – WASHINGTON – September 21 – Seemingly regular cycle of food contamination scares about various food processing facilities prompted Congress to require revisions to Food and Drug Administration food safety regulations.

On September 19 the FDA offered an early look at proposed rules on produce safety and preventive controls in human food production, plus preventive controls in animal food production and on foreign supplier verification programs.

A comment period on the rule proposals will begin after they are officially published in the Federal Register on Sept. 29.

CQ Roll Call’s Georgina Gustin reports that the new rules are designed to make the inspection process less burdensome, especially for small and organic food growers, as the agency is dropping a nine-month delay on developing risk analysis on manure and eases restrictions on the agricultural water quality standards.

The proposed rule for produce products also clarifies what constitutes a covered farm, saying that those with produce sales – not food sales – under $25,000 annually will not be subject to the rules.

Additionally, the revised regulations on preventive controls for animal food addresses concerns raised by brewers and livestock farmers, that unprocessed spent grains – a by-product of the brewing process – would be not be subject to new regulations when sold as animal feed.

The proposed rules on foreign supplier verification requires annual on site auditing of foreign suppliers, but companies with well-documented supply chains could opt out.

#ANS2014 

#animal-food, #congress, #fda, #washington

` FDA has granted approval to ` Pluristem Therapeutics ‘ to mass produce `Human Placenta Derived Stem Cell Products ‘

#AceHealthNews – ISRAEL – 23 March – The US Food and Drug Administration has granted approval http://www.pharmabiz.com/NewsDetails.aspx?aid=80807&sid=2to Pluristem Therapeutics to mass produce therapeutic human-placenta-derived stem cell products within its commercial-scale manufacturing facility in Haifa, Israel.

Pluristem’s Placental Expanded (PLX) products are mesenchymal-like adherent stromal cells – connective tissue cells in an organ – from human placentas, which are lush with hormones and proteins. The FDA has cleared PLX for use in studies on treating injuries, one step closer to full approval of PLX cells in treatments.

PLX products are made via Pluristem’s “automated 3D cell expansion manufacturing platform that uses its patented high-throughput culturing technologies, 3D bioreactors, and downstream equipment.”

“The PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an ‘off-the-shelf’ product that requires no tissue matching prior to administration,” according to Pluristem.

Pluristem operates out of a high-output facility in northern Israel that can produce about 150,000 doses of PLX products a year. http://on.rt.com/j7qdeo

From the CEO – http://www.pluristem.com/

Our vision at Pluristem Therapeutics inc. is to leverage our position as the global leader in placenta-based cell science to become the world’s leader in developing and manufacturing cell therapy products.

We believe our cutting edge technology can become the standard of care for treating a host of inflammatory and ischemic conditions.

We are in the process of achieving this vision by building a successful, winning team to maintain our standard of excellence in the research, development and production of cell therapies.

We continue to develop our understanding surrounding the mechanism of action of PLacental eXpanded (PLX) cells. We then leverage this understanding towards the development of these cells for additional markets. Currently we are actively pursuing indications in the peripheral vascular, pulmonary, orthopedic, ob-gyn and hematology markets.

We also believe “the Process is the Product.” This reflects our view that the precise control of the entire process, from obtaining cells from the source, to delivery to the patient, is vitally important to the success of a cell therapy product. Part of the reason we are able to obtain this precision in our cell expansion process is our exclusive ability to expand cells via our proprietary 3D technology.

Combining this “Powered by Pluristem” fully automated process with our increasing knowledge of the placental cell is the powerful engine towards identifying additional products for new markets and indications.

Every engine needs a driver, which returns me to the key to success for achieving our vision: the team. Our team has the ability, integrity, commitment and courage to develop breakthrough cell therapies that can transform the treatment of certain diseases and deliver value to our shareholders.
Zami Aberman
Chairman and CEO

#ANS2014

#fda, #federal-drug-administration-fda, #pluristem, #pluristem-therapeutics-incorporated

` Doctors are Warning of a `Brand New’ recently FDA-Approved `Pain-Killer’ `Zohydro’ is Deadly Dangerous’

#AceHealthNews says according to latest news from RT a new painkiller set to hit the market in March is coming under heavy fire from doctors and lawmakers warning of its powerful ability to kill.

Although the opiate Zohydro was ultimately approved by the US Food and Drug administration, that endorsement went against the recommendation given by the agency’s own advisory panel.

The panel voted 11 – 2 against approving the drug, but the FDA argued its availability is necessary to help patients un-fazed by current medication.

The new drug has not become available yet, but a group of more than 40 doctors is hoping to pre-empt its release by urging the FDA to reconsider its decision.

According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths.

The doctors warned that the drug could potentially kill an individual after taking only two Zohydro capsules.

A child, meanwhile, could suffer a fatal overdose from just one pill.

#ANS2014 & RT

#fda, #rt-news, #zohydro

#AceNewsServices says according to BI and Bloomberg they…

#AceNewsServices says according to BI and Bloomberg they have reported that Google X, the cordoned-off branch of Google that’s spawned stuff like Google Glass and the driver-less car, is now meeting with the FDA to discuss medical devices.

The whispered theory here is that there may be bio-sensors in Google Glass that will listen to your body and provide feedback to the device.

The meeting included at least four Google workers, some of whom have connections with Google X — and have done research on sensors, including contact lenses that help wearers monitor their biological data. Google staff met with those at the Food and Drug Administration who regulate eye devices and diagnostics for heart conditions, according to the agency’s public calendar.

More Soon ……………………………………………………………………………………………

#bloomberg-television, #fda, #google, #google-glass

IF: You Want People To Keep Raising Tax Dollars by Smoking – Let the FDA Regulate E-Cigarettes

#AceWorldNews says In 2010, the FDA determined that certain e-cigs were unapproved pharmaceutical products and detained or refused imports from some manufacturers. One manufacturer fought back, and a federal court held that e-cigs are not pharmaceutical products but that the FDA could regulate them as tobacco products.

“It seems pretty clear that the FDA will regulate electronic cigarettes like tobacco products,” said Theodore L. Wagener, an assistant professor at the University of Oklahoma Health Sciences Center who’s researching the products.

Regulating the cigarette look-a-likes as tobacco products would make them subject to the age, marketing and packaging restrictions that apply to traditional cigarettes. It might prohibit sales to minors, ban advertising on television and require warning labels on packaging.

The White House is reviewing a proposal from the FDA; the process might last 90 days or more.

Meanwhile, the debate about the potential benefits and risks of e-cigs has escalated.

Advocates promote the products as healthier alternatives to cigarettes that give users their nicotine fixes without the toxins and carcinogens generated by burning tobacco. Some advocates also say e-cigs might help smokers quit.

But critics say e-cigs may increase nicotine addiction and tobacco use among young people; they also point out that the FDA says not enough research has been done for consumers to know whether e-cigs are safe or harmful.

While the price of cigarettes has continuously increased since 1965, the percentage of that price going towards taxes is now half of what it was then.[19] While tobacco companies complain about the $1.01 cigarette tax, Phillip Morris, Reynolds American, and Lorillard have all increased their prices by almost $1.00 per pack on their own. Phillip Morris currently lists all taxes, including federal, state, local, and sales taxes, as 56.6% of the total cost of a pack of cigarettes.

READ MORE:

http://www.mcclatchydc.com/2013/11/26/209666/as-feds-ponder-future-of-e-cigarettes.html#emlnl=Morning_Newsletter

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#e-cigarettes, #fda, #lorillard, #phillip-morris, #taxes, #tobacco, #white-house