The Prometheus League
Breaking News and Updates
- Abolition Of Work
- Ai
- Alt-right
- Alternative Medicine
- Antifa
- Artificial General Intelligence
- Artificial Intelligence
- Artificial Super Intelligence
- Ascension
- Astronomy
- Atheism
- Atheist
- Atlas Shrugged
- Automation
- Ayn Rand
- Bahamas
- Bankruptcy
- Basic Income Guarantee
- Big Tech
- Bitcoin
- Black Lives Matter
- Blackjack
- Boca Chica Texas
- Brexit
- Caribbean
- Casino
- Casino Affiliate
- Cbd Oil
- Censorship
- Cf
- Chess Engines
- Childfree
- Cloning
- Cloud Computing
- Conscious Evolution
- Corona Virus
- Cosmic Heaven
- Covid-19
- Cryonics
- Cryptocurrency
- Cyberpunk
- Darwinism
- Democrat
- Designer Babies
- DNA
- Donald Trump
- Eczema
- Elon Musk
- Entheogens
- Ethical Egoism
- Eugenic Concepts
- Eugenics
- Euthanasia
- Evolution
- Extropian
- Extropianism
- Extropy
- Fake News
- Federalism
- Federalist
- Fifth Amendment
- Fifth Amendment
- Financial Independence
- First Amendment
- Fiscal Freedom
- Food Supplements
- Fourth Amendment
- Fourth Amendment
- Free Speech
- Freedom
- Freedom of Speech
- Futurism
- Futurist
- Gambling
- Gene Medicine
- Genetic Engineering
- Genome
- Germ Warfare
- Golden Rule
- Government Oppression
- Hedonism
- High Seas
- History
- Hubble Telescope
- Human Genetic Engineering
- Human Genetics
- Human Immortality
- Human Longevity
- Illuminati
- Immortality
- Immortality Medicine
- Intentional Communities
- Jacinda Ardern
- Jitsi
- Jordan Peterson
- Las Vegas
- Liberal
- Libertarian
- Libertarianism
- Liberty
- Life Extension
- Macau
- Marie Byrd Land
- Mars
- Mars Colonization
- Mars Colony
- Memetics
- Micronations
- Mind Uploading
- Minerva Reefs
- Modern Satanism
- Moon Colonization
- Nanotech
- National Vanguard
- NATO
- Neo-eugenics
- Neurohacking
- Neurotechnology
- New Utopia
- New Zealand
- Nihilism
- Nootropics
- NSA
- Oceania
- Offshore
- Olympics
- Online Casino
- Online Gambling
- Pantheism
- Personal Empowerment
- Poker
- Political Correctness
- Politically Incorrect
- Polygamy
- Populism
- Post Human
- Post Humanism
- Posthuman
- Posthumanism
- Private Islands
- Progress
- Proud Boys
- Psoriasis
- Psychedelics
- Putin
- Quantum Computing
- Quantum Physics
- Rationalism
- Republican
- Resource Based Economy
- Robotics
- Rockall
- Ron Paul
- Roulette
- Russia
- Sealand
- Seasteading
- Second Amendment
- Second Amendment
- Seychelles
- Singularitarianism
- Singularity
- Socio-economic Collapse
- Space Exploration
- Space Station
- Space Travel
- Spacex
- Sports Betting
- Sportsbook
- Superintelligence
- Survivalism
- Talmud
- Technology
- Teilhard De Charden
- Terraforming Mars
- The Singularity
- Tms
- Tor Browser
- Trance
- Transhuman
- Transhuman News
- Transhumanism
- Transhumanist
- Transtopian
- Transtopianism
- Ukraine
- Uncategorized
- Vaping
- Victimless Crimes
- Virtual Reality
- Wage Slavery
- War On Drugs
- Waveland
- Ww3
- Yahoo
- Zeitgeist Movement
-
Prometheism
-
Forbidden Fruit
-
The Evolutionary Perspective
Category Archives: Alternative Medicine
Resilient researchers: UW-La Crosse students adapt their research amid COVID-19 – University of Wisconsin System
Posted: August 9, 2021 at 8:52 am
Nico Lang and Cullen Schull, both May 2021 graduates, found success adapting their biochemistry research amid COVID-19.
A pair of UW-La Crosse biochemistry students didnt let COVID-19 stand in the way of their research.
Cullen Schull and Nico Lang, who each graduated with abachelors degree in biochemistryin May, had spent the past couple years researching greener routes of synthesis for high-purity curcumin, a powdery orange chemical produced by certain plants. Curcumin, the active ingredient in turmeric, has been used as a cooking ingredient and alternative medicine for centuries but also has numerous biological applications as a wonder drug.
Lang had been working on the synthesis and isolation of curcumin compounds using a green methodology and microwave energy. Typical industrial synthesis and isolation procedures are based on a report from the 1960s, taking a greater toll on the environment.
Unable to work in the lab due to COVID-19, Lang demonstrated the effectiveness of his greener approach using recently developed software the Environmental Assessment Tool for Organic Synthesis. He also completed a bibliography on the synthesis of curcumin and similar chemicals, placing his green methodology in perspective.
Schull had been working on a combinatory study to develop a simple and versatile method to obtain curcuminoids (analogues of curcumin) using a blend of synthetic and computational modeling.
From a biomedical standpoint, curcuminoids are shown to be even more effective than curcumin. However, a lack of knowledge about curcuminoid synthesis has resulted in a limited commercial availability of curcuminoids, as well as high prices.
Schulls synthetic work was put on hold during COVID-19. Instead, he used molecular modeling to better understand the mechanism of curcuminoid synthesis, gaining valuable data and experience conducting online research.
This summer, Schull is finishing his project and hoping to publish his manuscript.
His work helped earn a WiSys Spark grant, which was funded for the spring 2021 semester and summer 2021.
It is particularly remarkable that these two students felt the substantial impact of COVID-19 on their research but were able to use the forced online transition as an opportunity to take their research to a new level, saysValeria Stepanova, an assistant professor of chemistry and biochemistry and the students research advisor.
Lang has been accepted into the University of Utahs graduate chemistry program. Schull plans to pursue a doctorate in organic chemistry at Northwestern University.
Read the rest here:
Posted in Alternative Medicine
Comments Off on Resilient researchers: UW-La Crosse students adapt their research amid COVID-19 – University of Wisconsin System
This Massage Gun Is 20% Off and Will Sort Out Your Back Knots, but Can You Handle It? – Lifehacker Australia
Posted: at 8:52 am
At Lifehacker, we independently select and write about stuff we love and think you'll like too. We have affiliate and advertising partnerships, which means we may collect a share of sales or other compensation from the links on this page. BTW - prices are accurate and items in stock at the time of posting.
Lockdown again. Not unfamiliar, but definitely unwanted. I am, like Im sure most people are, trying to keep busy with a series of hobbies that arent outside my field of general interest, but far enough outside my immediate reach that I usually wouldnt be arsed with them in everyday reality. Ive begun parading as a limber geriatric, spending my increasingly free hours knitting, cooking soups with the persistence of a madwoman and running.
Running is a fickle friend of mine. We have periods of intense infatuation and then almost as quickly as we started up, I wont see her for months. There is no going steady for us. Its either a shotgun wedding in Las Vegas or the cold shoulder. During this lockdown Ive had to sub her back into my life to break up the Love Island marathons. When youre improving your mind at such a rapid rate, its important that you dont leave the body behind too.
Of course, this rapid transformation from couch potato to Usain Bolt with a uterus has left my body crampy and sore. Enter the Bob and Brad C2 massage gun a treat and a half.
Update 09/08: The Bob and Brad C2 massage gun is currently on sale for $110.99, down from $139.99, when you combine a 4% discount with a $25 off coupon via Amazon.
The massage gun is shaped like a drill and has a surprising weight to it. The design is rather ergonomic while the weight makes it feel sturdier, but I found it a bit too heavy and bulky to use at times.
The gun comes with five attachable heads ball, bullet, fork, flat and an air cushion. At first glance, these heads kind of look like some sort of medieval torture device. When I did finally try them out, these different heads were actually quite enjoyable.
The ball head, in particular, was my favourite as I found it really helped to loosen up my shoulders and lower back, which often get quite tight from hunching over a computer every day.
The different heads allow you to comfortably target different muscle groups, relieving your shoulders from the Millennial slouch or your thighs from that run you did one time. The massage gun has five gears, which really means there are five speed settings.
The instruction manual includes a guide that lets you know how hard you should be going on which part of your tender bod, but I found the speeds to be super intense, even on a lower setting. Setting it to gear two was more than enough for me, so I cant imagine how hectic it is at top speed. I wouldnt be cranking it up to full blast on your neck.
Surprisingly, the massage gun is not a new invention. In 1883 English physician Joseph Mortimer Granville invented an electric vibrator, which was not used for sexual pleasure but rather for curing ailments of the body.
Similar devices, such as the steam-powered manipulator invented by Dr. George Taylor were also in use around the same time. These massagers were considered to be alternative medicine and believed to improve male impotence, stimulate hair growth for the balding, soothe upset stomachs for colic children and even help cure broken bones.
Unsurprisingly, they werent the magic cure-all for every imaginable complaint. However, massage guns stuck around and found their place in the modern zeitgeist because they are pretty good at relaxing sore muscles.
The Bob and Brad C2 massage gun is small, compact, and comes in a little briefcase, which is perfect for transporting it from your living room to the backyard, or wherever else you may be venturing these days.
Compared to big name massage gun brands likes Theragun, which retails in the range of $349 to $899, the Bob and Brad massager goes for a more affordable $139.99 (or even less, as its currently on sale with the aforementioned $29 discount).
Its a convenient solution if your masseuse is closed and your dicky back hasnt gotten the memo. Youre able to use the massager by yourself or you can ask your housemates to target some hard-to-reach areas whilst you lay splayed on the living room floor like a lumpy pancake.
For me, I found the massage gun to be a bit bulky and quite intense to use, even on a low speed. That might not be a problem for some, but its worth considering if you want a massage gun that wont tire you out while using it.
If youre interested in having a powerful massage on tap, this is the perfect product for you.
Read more here:
Posted in Alternative Medicine
Comments Off on This Massage Gun Is 20% Off and Will Sort Out Your Back Knots, but Can You Handle It? – Lifehacker Australia
From the Editor-in-Chief’s desk: Your August 8 briefing – Fiji Times
Posted: at 8:52 am
Bula everyone
It is a cool night here in the Capital City, Suva.
A southerly was blowing in throughout the day.
Tonight, lets talk about an issue that has been raised about COVID-19.
It is interesting how various scenarios have been lapped up in connection with the pandemic.
The head of obstetrics and gynaecology unit at the Fiji National University (FNU) College of Medicine, Nursing and Health Sciences, Litia Narube raised an interesting issue when she spoke about Christianity and the virus.
To think that Christians do not die from COVID-19, she said, or are specially protected from COVID-19 is false.
Christians also die from COVID-19, she pointed out. So being in, you know, were just seeing the things that affect people to not access the care thats available and care is free of charge so what is the hesitancy, she said.
During a FNU panel discussion on Monday, she said late presentation of pregnant women was a major issue. She pleaded with everyone, especially pregnant women, to present themselves to the hospital if they have symptoms of COVID-19.
We are pleading with everyone to present early and for whatever reason that you are at home, nursing your flu-like symptoms, you know, maybe thinking that you need to try praying for the woman first or try the herbal medicine, the vevedu that everybodys talking about.
While she acknowledged faith-based processes, praying, and herbal remedy, she insisted people still had to be presented early to hospital.
Thats what the plea is to present early and get the woman sorted because studies have shown that a woman who is infected with COVID-19 is more than 20 times at risk of dying because of COVID-19 and pregnancy so, you know, the evidence is out. The evidence is out for vaccination, evidence is out for how COVID-19 is, how it affects pregnant women but now its just trying to combat or trying to get people to understand the evidence, you know, compared with this coconut wireless that just takes over.
The scenarios add to the many interesting lines of thought that are intertwined with the fight against COVID-19.
Ultimately though, we are left with one thought, which is the safety and wellbeing of every Fijian.
That means aggressively fighting the virus together as a nation.
Whatever our views are, it is difficult to get past the need to keep everyone safe.
That means doing what we are expected to do in the best interest of all Fijians.
Decisions must focus on keeping the wider community safe. It must embrace safety measures that are critically important for us all.
So decisions must weigh that against any line of thought that places people in danger.
The virus cuts through every imaginary demarcation line.
It knows no barriers. It makes no differences and it does not matter who you are.
No one is immune from the threat of the virus.
But we have the benefit of knowledge. So lets do the right thing.
As we look up to the powers that be to make tough calls which are good for us as a nation, and take the lead in terms of reassurance, we still have to take ownership of this fight as individuals. Together Fiji!
LATE UPDATE
682 new cases
The permanent secretary for Health and Medical Services Dr James Fong has just announced 682 new cases of COVID-19 for the 24 hour period that ended at 8am today. He said 193 cases were from the Western Division and 489 cases were from the Central Division.
Meanwhile, here are some headlines that made The Sunday Times edition for August 8.
PAGE 1
Opposition play a critical role
Political Party leaders during a press conference. Picture: FILE
LEADERS of five political opposition parties in the country say they play a critical role in providing people with alternative views. Their comments came to light after some political party leaders and other members of the parties were hauled into the CID headquarters in Toorak, Suva, on several occasions for caution interviews on their statements and views on Bill 17 which amends Section 12 of the iTaukei Land Act.
PAGE 3
Plea from Sabha
REFRAIN from spreading hate in the country. Thats the plea from the Sanatan Dharam Pratinidhi Sabha of Fiji national president Sarju Prasad amid social media posts allegedly instigating violence in certain communities in Fiji. Mr Prasad said people who were involved in these alleged activities were mentally sick.
Political leaders claim intimidation
LEADERS of the political opposition parties in the country claim their party members, workers, and supporters in Fiji are being intimidated and harassed. The political party opposition leaders expressed these sentiments after they and other members of their parties were hauled into the CID headquarters in Toorak, Suva, on several occasions for caution interviews on their statements and views on Bill 17 to amend Section 12 of the iTaukei Lands Act.
PAGE 4
Lakeba vaccination drive complete
SONGS broke out in the seven villages around Lakeba after the completion of vaccination programs which began on the chiefly island of the Lau Province on Tuesday last week with 748 of the 842 target populations on the island vaccinated with AstraZeneca vaccines.
Lauans stranded
A TOTAL of 508 Lauans have been stranded on Viti Levu from April when the second wave of COVID-19 began, eagerly awaiting the opening of inter-island travel to return home.
Vaccine commitment by Australia
Australian High Commissioner to Fiji John Feakes(left) and Minister for Health and MedicalServices Dr Ifereimi Waqainabete during thevaccine handover. Picture: JONA KONATACI
AUSTRALIA has committed over 660, 000 AstraZeneca vaccines in the past three months to help the Fijian government in the fight against the deadly COVID-19 pandemic. The Australian High Commission to Fiji noted this after an additional 100, 000 Australian-manufactured COVID-19 AstraZeneca vaccines arrived in a Fiji Airways flight at the Nadi International Airport on Thursday.
LETTERS TO THE EDITOR
Image: THE FIJI TIMES
There are many interesting letters on Pages 6 and 7. Get a feel of what people are talking about, and what interests them.
FEATURE/OPINION
We have a list of interesting articles for your Sunday reading pleasure.
Image: THE FIJI TIMES
Read JOHN KAMEAS Behind The News, Discovering Fiji, Bollybaat, Food with Chef LANCE SEETO, History and much more.
Image: THE FIJI TIMES
SPORTS
Image: THE FIJI TIMES
The big one on the back page is about the Rugby League World Cup.
Theres a lot more to read inside but youll have to get a copy to know what we are talking about! Happy reading!
Visit link:
From the Editor-in-Chief's desk: Your August 8 briefing - Fiji Times
Posted in Alternative Medicine
Comments Off on From the Editor-in-Chief’s desk: Your August 8 briefing – Fiji Times
6 Signs Someone Is Lying About You To Everyone And What You Can Do About It – YourTango
Posted: at 8:52 am
Have you ever had the feeling that something has changed in your relationship with an individual or group?
There'salways a strong possibility that someone has spread lies about you that you're not aware of. And when people lie about you, it changes everything.
Liars seeking to diminish your value to another individual or organization and are very adept at casting aspersions.
The lies don'thave to be terribly involved or extremethey just have to cast enough "shade"to cause others to value the individual less.
When people are jealous or feeling threatened by your presence, they often spread lies that they hope will get you rejected by someone, removed from a group, or, at the very least, diminish your influence.
RELATED:How To Tell If Someone Is Lying To You
Pay attention to their behavior and body language. When you arrive, nobody says "hello" likethey once did. Nobody extends their hand first or moves physically to greet you when you arrive.
Assuming you have had no interaction with the individual or group prior to the behavioral interaction change, the only explanation would be that someone has undermined you in some way and to your detriment.
When people don'ttalk in your presence, there's usually a reason.
There may be things they want to discuss that they don'twant you to know about. Or you may be the subject of what they are talking aboutand they don'twant you to overhear their conversation.
Pay attention to their facial expressions. When people change their behavior because of something someone has told them and not because of something the individual in question has done, they do feel some guilt.
They know what they are doing is not based on anything the individual deserves and they feel badly about what they are doing, so it's difficult to look the person in the eye.
Some people also may no longer seek your opinion when making plans and decisions the way they did before.
You will certainly have a sense of being left out.
There'sno informal touching when talking, greeting, or leaving.
You may feel that they are being cold and aloof.
There's that feeling of "je ne se quoi" that you can't put your finger on.
Something is just off, but you know you'vedone nothing to warrant these changes.
RELATED:7 Subtle-But-Noticeable Signs Someone's Lying To You
Reinforce their positive feelings by maintaining your consistent behavior, and remaining above reproach. Dont change your behavior by hopping on the defensive or distrusting them because that may play into the hands of the liar.
Do the same things you did before that encouraged the individual or group to bring you into their environment. Exhibit the same positive, friendly, informative behavior you did before their feelings seemed to change.
Hopefully, you will be able to get to the bottom of things throughthe changed individual or a member of the changed group at some point in time, to see what the liar said or to get someone to confide in you what they suspect to be the problem.
You should be able to outlast the lies and dispel their concerns sufficiently to raise questions about the individual trying to undermine your presence.
The more your behavior is contrary to the lie, the sooner people will realize they are in error and should actually be more concerned about the liar.
Join now for YourTango's trending articles, top expert advice and personal horoscopes delivered straight to your inbox each morning.
There may be a point at which you can jokingly state, "If I didnt know better, I would think someone was spreading lies about me behind my back."
Someone may come and tell you what happened.
The important thing is to stay a part of the group or maintain your relationship with the changed individual long enough to clear your name and determine who the culprit is and expose them for the liar they are.
You can only do that if you maintain a positive and productive demeanor and presenceso that you will be kept around long enough to get to the bottom of the lies and make the individual pay for what they did.
Do not allow your hurt feelings or anger to get the best of you. Never allow your adrenaline to supersede your clarity.Keep it together to rectify the situation.
Success is the best revenge. The culprit is trying to get rid of you, so if you leave or act out, you will enable them to justify your removal.
Do not, under any circumstances, give them the satisfaction of seeing you out of control. Just hang in there long enough to win!
RELATED:5 Different Types Of Lies You Tell Without Noticing (And How To Be More Honest)
PartheniaIzzardis a Psychologist, Certified Natural Healthcare Practitioner, Author, and Radio Talk Show Host. Her desire is to provide services and disseminate information related to alternative medicine therapies to facilitate your wellness journey. For more information, visit Alternative Medicine Therapies.
This article was originally published at Alternative Medicine Therapies. Reprinted with permission from the author.
Go here to read the rest:
6 Signs Someone Is Lying About You To Everyone And What You Can Do About It - YourTango
Posted in Alternative Medicine
Comments Off on 6 Signs Someone Is Lying About You To Everyone And What You Can Do About It – YourTango
Oncologists Underestimate the Number of Breast Cancer Patients Who Use Complementary Medicine – Cancer Health Treatment News
Posted: June 28, 2021 at 9:41 pm
Many more people who have breast cancer access complementary therapies than oncologists believe, according to new study results presented at the 2021 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Cancer is a complex disease that affects every component of a patients life. While conventional medicine is effective for curing disease, it can fall short in helping patients heal, said Wayne Jonas, MD, a study coauthor and the executive director of integrative health programs at the Samueli Foundation, according to The ASCO Post, the societys publication.
Complementary medicine, also known as integrative medicine, refers to a range of practices that are used in conjunction with standard medical ones, according to the National Institutes of Health. These include yoga, tai chi, qi gong, meditation, mindfulness and acupuncture. (When these are employed instead of conventional medicine, by contrast, they are referred to as alternative medicine and are associated with poorer outcomes.)
While many of these practices have been shown to improve quality of life and health during and after cancer treatment, people with cancer need expert guidance to integrate them safely and effectively into their regimens. When oncologists fail to discuss complementary medicine with their patients, their patients often must resort to tracking down information and resources on their own.
"Many oncologists are generally supportive of integrating complementary and lifestyle therapies with conventional medical treatment, but the education and guidance given to patients varies widely," Terri Crudup, the studys first author and the senior principal of primary intelligence at the data science company IQVIA, told The ASCO Post.
The new study involved national surveys that were administered to 115 clinical oncologists who treat breast cancer and 164 people with breast cancer who had been diagnosed less than two years before. The surveys were conducted by IQVIA in late 2020, according to the Post.
The majority of patients (73%) surveyed reported accessing one or more types of complementary medicine in the wake of their diagnosis. By contrast, the majority of oncologists surveyed were under the impression that only a minority of patients (43%) did. The oncologists also revealed that they discussed complementary medicine with only roughly 50% of their patients.
Both populations saw the potential value of complementary medicine. The majority of oncologists (66%) and the majority of patients (65%) believed that accessing complementary medicine improved quality of life. In addition, the majority of patients (60%) thought that such treatments improved their health outcomes.
However, oncologists and patients occasionally disagreed on the effectiveness of specific practices. Perhaps as a result, patients reported that their oncologists provided fewer recommendations for spiritual services and meditation and mindfulness than they did for, say, nutrition consultations, support groups, psychological support and exercise.
The study also found that patients preferred learning about complementary medicine from their oncologists rather than from oncology nurses or patient navigators.
"Oncologists and the institutions at which they practice should look for methods to educate and expose patients to a variety of safe and effective complementary and lifestyle therapies to find the ones that will help their patients most, Crudup said, according to the Post.
For more on cancer patients and nontraditional medicine, read People With Cancer Are Using Complementary MedicineWithout Telling Their Doctors.
See the original post here:
Posted in Alternative Medicine
Comments Off on Oncologists Underestimate the Number of Breast Cancer Patients Who Use Complementary Medicine – Cancer Health Treatment News
BioMarin Resubmits Marketing Authorization Application (MAA) to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A…
Posted: at 9:41 pm
SAN RAFAEL, Calif., June 28, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the company resubmitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its investigational gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.In May 2021, the EMA granted the Company's request for accelerated assessment. Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP).A CHMP opinion is anticipated in the first half of 2022.
The submission includes safety and efficacy data from the 134 subjects enrolled in the Phase 3 GENEr8-1 study, all of whom have been followed for at least one year after treatment with valoctocogene roxaparvovec, as well as four and three years of follow-up from the 6e13 vg/kg and 4e13 vg/kg dose cohorts, respectively, in the ongoing Phase 1/2 dose escalation study.
"This is an important step to deliver the potential first gene therapy for people with hemophilia A. The data package for this submission includes the largest Phase 3 study in any gene therapy for hemophilia A supported by up to four years of observation in a Phase 1/2 study," said Hank Fuchs, M.D., President, Worldwide Research and Development at BioMarin. "We look forward to the EMA reviewing the robust data set. We believe that valoctocogene roxaparvovec represents a scientific innovation that may become an important treatment choice for those people who have unmet medical needs."
"This submission is important for the bleeding disorders community given the need for continued scientific and medical innovation to provide a treatment option to address unmet needs for many people with hemophilia A," said Brian O Mahony FACSLM, Chief Executive, Irish Haemophilia Society. "We believe that therapeutic choices are critical for our community to provide access to alternative treatment approaches with the potential to address individual patient needs."
Applications are eligible for accelerated assessment if the CHMP and CAT decide the product is of major interest for public health, particularly from the point of view of therapeutic innovation. Evaluating a MAA under the EMA centralized procedure can take up to 210 days, not counting clock stops when applicants are requested to provide additional information. On request, the CHMP and CAT can reduce the time frame to 150 days if the applicant provides sufficient justification for an accelerated assessment, although an application initially designated for accelerated assessment can revert to the standard procedure during the review for a variety of reasons. The decision to grant accelerated assessment has no impact on the eventual CHMP and CAT opinion on whether a marketing authorization should be granted.
Regulatory Status
In the United States, BioMarin intends to submit two-year follow-up safety and efficacy data on all study participants from the Phase 3 GENEr8-1 study to support the benefit/risk assessment of valoctocogene roxaparvovec, as previously requested by the Food and Drug Administration (FDA). BioMarin is targeting a Biologics License Application (BLA) resubmission in the second quarter of 2022, assuming favorable study results, followed by an expected six-month review by the FDA.
The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to valoctocogene roxaparvovec in March 2021. RMAT is an expedited program intended to facilitate development and review of regenerative medicine therapies, such as valoctocogene roxaparvovec, that are expected to address an unmet medical need in patients with serious conditions. The RMAT designation is complementary to Breakthrough Therapy Designation, which the Company received in 2017.
In addition to the RMAT Designation and Breakthrough Therapy Designation, BioMarin's valoctocogene roxaparvovec also has received orphan drug designation from the FDA and EMA for the treatment of severe hemophilia A.The Orphan Drug Designation program is intended to advance the evaluation and development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions.
Robust Clinical Program
BioMarin has multiple clinical studies underway in its comprehensive gene therapy program for the treatment of hemophilia A. In addition to the global Phase 3 study GENEr8-1 and the ongoing Phase 1/2 dose escalation study, the Company is actively enrolling participants in a Phase 3b, single arm, open-label study to evaluate the efficacy and safety of valoctocogene roxaparvovec at a dose of 6e13 vg/kg with prophylactic corticosteroids in people with hemophilia A. The Company is also running a Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with hemophilia A with pre-existing AAV5 antibodies, as well as another Phase 1/2 Study with the 6e13 vg/kg dose of valoctocogene roxaparvovec in people with hemophilia A with active or prior FVIII inhibitors.
About Hemophilia A
People living with hemophilia A lack sufficient functioning Factor VIII protein to help their blood clot and are at risk for painful and/or potentially life-threatening bleeds from even modest injuries. Additionally, people with the most severe form of hemophilia A (FVIII levels <1%) often experience painful, spontaneous bleeds into their muscles or joints.Individuals with the most severe form of hemophilia A make up approximately45 percent of the hemophilia A population.People with hemophilia A with moderate (FVIII 1-5%) or mild (FVIII 5-40%) disease show a much-reduced propensity to bleed.The standard of care for adults with severe hemophilia A is a prophylactic regimen of replacement Factor VIII infusions administered intravenously up to two to three times per week or 100 to 150 infusions per year.Despite these regimens, many people continue to experience breakthrough bleeds, resulting in progressive and debilitating joint damage, which can have a major impact on their quality of life.
Hemophilia A, also called Factor VIII deficiency or classic hemophilia, is an X-linked genetic disorder caused by missing or defective Factor VIII, a clotting protein. Although it is passed down from parents to children, about 1/3 of cases are caused by a spontaneous mutation, a new mutation that was not inherited. Approximately 1 in 10,000 people have Hemophilia A.
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for serious and life-threatening rare and ultra-rare genetic diseases. The Company's portfolio consists of six commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visitwww.biomarin.com. Information on BioMarin's website is not incorporated by reference into this press release.
Forward-Looking Statements
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including without limitation, statements about (i) the development of BioMarin's valoctocogene roxaparvovec program generally, (ii) the anticipated timing of a CHMP opinion in the first half of 2022, (iii) BioMarin's intention to submit to the U.S. Food and Drug Administration (FDA) two-year follow-up safety and efficacy data on all study participants from the GENEr8-1 study to support the benefit/risk assessment of valoctocogene roxaparvovec, (iv) BioMarin targeting resubmission of a Biologics License Application in the second quarter of 2022 assuming favorable study results, followed by an expected six-month review procedure by the FDA, and (v) the timing of the regulatory activities in the U.S and Europe, including validation and timing of potential approvals and the expected review procedures. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned preclinical studies and clinical trials of valoctocogene roxaparvovec; additional data from the continuation of the Phase 1/2 trial and the Phase 3 trial, any potential adverse events observed in the continuing monitoring of the participants in the clinical trials; the content and timing of decisions by the FDA, the European Commission and other regulatory authorities; the content and timing of decisions by local and central ethics committees regarding the clinical trials; our ability to successfully manufacture valoctocogene roxaparvovec for the clinical trials and commercially, if approved; and those other risks detailed from time to time under the caption "Risk Factors" and elsewhere in BioMarin's Securities and Exchange Commission (SEC) filings, including BioMarin's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and future filings and reports by BioMarin. BioMarin undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.
BioMarin is a registered trademark of BioMarin Pharmaceutical Inc.
Contacts:
Investors
Media
Traci McCarty
Debra Charlesworth
BioMarin Pharmaceutical Inc.
BioMarin Pharmaceutical Inc.
(415) 455-7558
(415) 455-7451
View original content to download multimedia:https://www.prnewswire.com/news-releases/biomarin-resubmits-marketing-authorization-application-maa-to-european-medicines-agency-for-valoctocogene-roxaparvovec-to-treat-severe-hemophilia-a-301320869.html
SOURCE BioMarin Pharmaceutical Inc.
More here:
Posted in Alternative Medicine
Comments Off on BioMarin Resubmits Marketing Authorization Application (MAA) to European Medicines Agency for Valoctocogene Roxaparvovec to Treat Severe Hemophilia A…
UNC-Led Review Details Lack of High-Quality Evidence to Support Supplements, Alternative Therapies for Weight Loss – Endocrinology Network
Posted: at 9:41 pm
A review of data from more than 315 clinical trials of weight loss supplements has returned results suggests very little strong evidence exists to support use of dietary supplements and alternative therapies as weight loss interventions in adults.
A systematic conducted by investigators at the University of North Carolina (UNC), results of the study suggest risk of bias and sufficiency varied widely across the studies examined and less than 17% of trials were considered to be of low risk of bias and sufficient to support efficacy.
"Our findings are important for clinicians, researchers, and industry alike as they suggest the need for rigorous evaluation of products for weight loss," said lead investigator John Batsis, MD, associate professor in the Division of Geriatric Medicine at the UNC School of Medicine and in the Department of Nutrition at the UNC Gillings School of Global Public Health, in a statement. "Only then can we produce data that allows clinicians to provide input and advice with a higher degree of certainty to our patients."
As the obesity epidemic continues to plague the US and other developed nations, the popularity of weight loss supplements and different dietary approaches has skyrocketed. With an interest in exploring claims of efficacy made by many manufacturers in the dietary supplement industry, Batsis and a team of colleagues sought to evaluate the current available evidence base related to use of these supplements and dietary approaches.
To do so, Batsis and colleagues designed the study as a systematic review of work assessing dietary supplements and alternative therapies for weight loss from within the Medline, Cochrane Library, Web of Science, CINAHL, and Embase databases. For inclusion in the review, studies needed to be designed as randomized clinical trials, published in English, contain patients with overweight or obesity, and examine a patient population 18 years of age or older.
A total of 20,504 records were identified in the investigators' initial query. After exclusion of duplicates and those not meeting inclusion criteria, 1743 full-text manuscripts were identified for assessment and 315 were ultimately included in the final review. These 315 examined 14 different types of dietary interventions, including calcium and vitamin D supplements, chitosan, chocolate/cocoa, green tea, guar gum, mind-body, and pyruvate.
Upon assessment, investigators found the risk of bias varied widely across the studies included in the review Overall, 52 (16.5%) studies were classified as having a low risk of bias. Of these, 16 (31%) demonstrated significant pre/post weight changes compared to placebo therapy. Investigators pointed out the weight loss observed in these studies was 0.3-4.93 kg. Trials demonstrating significant weight loss included 1 trial on chitosan, 1 on chromium, 5 on ephedra or caffeine, 2 on garcinia, 2 on green tea, and 1 on conjugated linoleum acid.
In a perspective statement from The Obesity Society, authors underlined the need for clinicians and providers to be aware of the lack of evidence surrounding many of these supplements, despite unregulated claims related to efficacy.
Our recommendation to clinicians is to consider the lack of evidence for non-FDA-approved dietary supplements and therapies and guide their patients toward tested weight management approaches. Public and private entities should provide adequate resources for obesity management. Finally, we call on regulatory authorities to critically examine the dietary supplement industry, including their role in promoting misleading claims and marketing products that have potential harm to patients, wrote investigators.
This study, A Systematic Review of Dietary Supplements and Alternative Therapies for Weight Loss, was published in Obesity.
Read more from the original source:
Posted in Alternative Medicine
Comments Off on UNC-Led Review Details Lack of High-Quality Evidence to Support Supplements, Alternative Therapies for Weight Loss – Endocrinology Network
Earl Baldwin of Bewdley, defender of his grandfather Stanleys political reputation and advocate of complementary medicine obituary – Telegraph.co.uk
Posted: at 9:41 pm
Edward Alfred Alexander Baldwin, himself a son of Worcestershire, was born on January 3 1938. His father, (Arthur) Windham, a businessman and author (known widely by the affectionate nickname, Bloggs), inherited the title in 1958 from his homosexual elder brother, Oliver, who as a Labour MP had sat opposite his father Stanley Baldwin in the Commons, the only prime minister to endure such an experience.
Edwards mother (Joan) Elspeth, ne Tomes, was recalled by James Lees-Milne as a beauty with keen blue eyes and the transparent skin of the very frail. Lees-Milne adored her husband for his enchanting dry sense of the ludicrous.
After Eton, and National Service in the Intelligence Corps, where Edward became a second lieutenant in 1957, he read Modern Languages and Law at Trinity College, Cambridge.
A gifted linguist, he taught French and German at Christs Hospital in Sussex and later at Hemel Hempstead School, a large comprehensive. He would prove a firm supporter of the comprehensive model during a 10-year stint (1978-88) in education administration, working first in Leicestershire and subsequently in Oxfordshire, where he was area education officer.
An accident to his knees while hill-climbing, one of his passions (along with tennis and ski-ing), turned him into an ardent advocate of alternative medicine, after Harley Street failed to relieve the pain.
He described what happened in an article published in 2003: Hobbling with knee bandages and a mindset of incurability, I was directed by a colleague to a spiritual healer in a back street in Cambridge. He spent half an hour waving his hands over my knees while discoursing on his life as a schoolmaster and Harold Wilsons politics I shall never forget my astonishment at levering myself out of bed the next morning to find the pain had vanished.
While not promoting this particular remedy widely, Baldwin became convinced that conventional healthcare practitioners should become familiar with complementary and alternative therapies. They should, he thought, be partners, not opponents.
It was a theme that recurred frequently in his quietly, but effectively, argued speeches in the House of Lords, where he took his seat on the cross-benches in 1988. So good to see a Baldwin in Parliament again, Lord (Alec) Home said to him, a comment that gave him great pleasure.
Baldwin was a member of the Research Council for Complementary Medicine from 1989 to 1991. Between 1992 and 2002 he was joint chairman of the all-party parliamentary group on alternative and complementary medicine. He pressed for high professional standards maintained by inspection and regulation.
Throughout the 1990s, Baldwin chaired the British Acupuncture Accreditation Board, established to authorise degree-level acupuncture courses. He felt that the reputation of alternative medicine gained useful recognition in a report of a Lords select committee in 2000, in which he played a leading part.
The improved regulatory structures for which it called reflected his thinking. Only slightly less important to him was the campaign against fluoridation, in which he was prominent.
See the article here:
Posted in Alternative Medicine
Comments Off on Earl Baldwin of Bewdley, defender of his grandfather Stanleys political reputation and advocate of complementary medicine obituary – Telegraph.co.uk
Complementary And Alternative Medicine Market by Trends, Key Players, Driver, Segmentation, Forecast to 2028 The Manomet Current – The Manomet…
Posted: at 9:41 pm
Complementary And Alternative Medicine Market research report conducts study on production capacity, consumption, import, and export for all major regions across the globe. The report is a professional in-depth study on the current state of the market. Analysis and discussion of important industry trends, market size, and market share estimates are revealed in the report. The market report also contains the drivers and restraints for this market that are derived from SWOT analysis, and also shows all the recent developments, product launches, joint ventures, mergers, and acquisitions by the several key players and brands that are driving the market by systemic company profiles.
Getting well-versed with the most relevant product and market information helps businesses accomplish sustainable growth in the market. According to this report, the market renovation will mainly take place due to the actions of key players or brands like developments, product launches, joint ventures, mergers, and acquisitions.
Complementary and Alternative Medicine Marketis estimated to grow at a healthy CAGR for 2020 to 2027 with factors such as, lack of scientific results and challenges associated with integration restraining the market growth in the above mentioned forecasted period.
Download Exclusive Sample (350 Pages PDF) Report @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-complementary-and-alternative-medicine-market&shrikesh
Major Market Key Players:
The major players covered in the complementary and alternative medicine market are Nordic Naturals, Natures Bounty, Unity Woods Yoga Center, Columbia Nutritional, First Natural Brands Ltd., Ayush Ayurveda, Sheng Chang Pharmaceutical Company, Pure Encapsulations, LLC. Quantum-Touch, and Herb Pharm, LLC among others.
Significant highlights covered in this research report:
Some of the Major Highlights of TOC covers:
Chapter 1: Methodology & Scope
Chapter 2: Executive Summary
Chapter 3: Access Control Industry Insights
Chapter 4: Access Control Market, By Region
Chapter 5: Company Profile
The Latest Free TOC of This Report @ https://www.databridgemarketresearch.com/toc/?dbmr=global-complementary-and-alternative-medicine-market&shrikesh
Some Notable Report Offerings:
We will provide you an analysis of the extent to which this market research report acquires commercial characteristics along with examples or instances of information that helps you to understand it better.
We will also help to identify customary/ standard terms and conditions, as offers, worthiness, warranty, and others for the in this market research report industry.
Also, this report will help you to identify any trends to forecast in this market research report growth rates.
The analyzed report will forecast the general tendency for supply and demand in this market research report.
Why Go For Data Bridge Market Research?
Data Bridge Market Research is a versatile market research and consulting firm with over 500 analysts working in different industries. We have catered more than 40% of the fortune 500 companies ly and have a network of more than 5000+ clientele around the globe. Our coverage of industries include Medical Devices, Pharmaceuticals, Biotechnology, Semiconductors, Machinery, Information and Communication Technology, Automobiles and Automotive, Chemical and Material, Packaging, Food and Beverages, Cosmetics, Specialty Chemicals, Fast Moving Consumer Goods, Robotics, among many others. We provide a variety of services such as market verified industry reports, technology trend analysis, Formative market research, strategic consulting, vendor analysis, production and demand analysis, consumer impact studies among many others.
Contact:
Data Bridge Market Research
US: +1 888 387 2818
UK: +44 208 089 1725
Hong Kong: +852 8192 7475
Email: sales@databridgemarketresearch.com
More:
Posted in Alternative Medicine
Comments Off on Complementary And Alternative Medicine Market by Trends, Key Players, Driver, Segmentation, Forecast to 2028 The Manomet Current – The Manomet…
Blood test shows promise for predicting treatment response in metastatic HPV-positive throat cancer – Michigan Medicine
Posted: at 9:41 pm
A sensitive blood test being developed by a team of researchers at the University of Michigan Rogel Cancer Center shows promise for predicting whether patients with metastatic HPV-positive throat cancer will respond to treatment months earlier than standard imaging scans.
Thats according to a study, published in Oncotarget, validating the test in a small group of patients with metastatic human papillomavirus-related oropharyngeal squamous cell carcinoma a type of head and neck cancer that develops in the back of the mouth and in the throat.
If the test can quickly determine that a treatment approach isnt helping, it could allow doctors to seek out alternative therapies or clinical trials in a more timely manner. It could also potentially spare some patients months of toxic side effects from a treatment that isnt working.
Currently, the only way doctors know if a treatment is working is for the patient to get an imaging scan every few months to see whether their tumors are shrinking, said oncologist Paul Swiecicki, M.D., one of the studys senior authors. And this isnt fully accurate since some cancers show what we call pseudoprogression, where a successful treatment actually makes the tumors bigger before it shrinks them.
Like Podcasts? Add the Michigan Medicine News Break oniTunes, Google Podcast or anywhere you listen to podcasts.
Our goal was to develop a test that could tell us whether a treatment is likely to work after a single cycle, he continued.
The research comes amid a rising incidence of throat cancer caused by human papillomavirus infections, which are often spread through sexual activity. Once the cancer has recurred or spread within the body, patients typically only live for about one year. Furthermore, most of the available treatments, such as immunotherapy, work for less than 20% of patients and can have significant side effects.
The test is a form of liquid biopsy that looks for DNA shed by a patients cancer cells into their bloodstream using a method known as digital droplet PCR, which can amplify minute amounts of DNA for analysis.
Development of the test was led by co-first authors Catherine Haring, M.D., an otolaryngology resident, and Chandan Bhambhani, Ph.D., a postdoctoral research fellow in the lab of senior study author Muneesh Tewari, M.D., Ph.D.
We can actually identify DNA from a small tumor at the back of the throat circulating throughout the entire bloodstream, Haring said.
"From a single tube of blood, this technology can isolate a single copy of tumor DNA, Bhambhani added. And quantifying the number of copies cantell us whether a patients cancer is responding to treatment.
The study analyzed more than 100 samples taken over nearly two years from 16 patients with advanced cancer that was positive for HPV 16, one of the most common, high-risk types of HPV infection. Seven of the patients were treated with immunotherapy regimens. Eleven patients underwent treatment that included chemotherapy.
The researchers found that increasing levels of HPV-positive circulating tumor DNA after a course of treatment were a strong indicator that the cancer was not responding to the treatment. And that the tumor DNA could be detected months ahead of tumor growth that can be measured on imaging scans.
Swiecicki points to one of the patients in the study as an example.
The patient underwent chemotherapy treatment for about 200 days. Their HPV 16-positive circulating tumor DNA fell to nearly zero for the first 100 days and imaging scans showed the disease had stabilized. But copies of the HPV 16 DNA started to multiply in their blood between day 100 and day 200, when the disease progression was ultimately detected on imaging scans.
In the future, the idea is that the test would give us a window of time about 100 days in this example to find alternative therapies or a clinical trial, Swiecicki said. And this particular patient did have significant toxicities from the therapy, some of which potentially could have been avoided once it became clear the cancer was no longer responding to the treatment.
Senior study author Chad Brenner, Ph.D., an associate professor in the Department of Otolaryngology-Head and Neck Surgery, notes that scientists around the world have been working to develop similar tests. The success at U-M was the result of collaboration that involved clinicians as well as researchers with expertise in next-generation sequencing and in the genetics of head and neck cancer.
More here:
Posted in Alternative Medicine
Comments Off on Blood test shows promise for predicting treatment response in metastatic HPV-positive throat cancer – Michigan Medicine