An esteemed member of the hallowed halls @rock brought the rort known as $AIMT to Jungle’s attention. Jungle has things to do, places to go, people to see. Howevever, this nonsense has gripped Jungle over her 6th cup of tea. Jungle is living an asynchronus life at the moment and lacks the gusto for a true missive. However, the inane mosaic is presented, with low-grade disgust. First and foremost understand this:
The Global Hand Sanitizer Market size was valued at $919 million in 2016 to reach $1,755 million by 2023, and is anticipated to grow at a CAGR of 9.9% from 2017 to 2023. Hand sanitizer is an antiseptic solution, which is used as an alternative to soap and water. It is used to prevent the transmission of infection, which is majorly caused through hand transmission, further causing several diseases such as nosocomial food-borne illness and others
Wash your stupid hands with soap and water and quit using these idiotc products. The FDA itself questioned the efficacy of this bullshit.
Quoting the executive summary of the proposal:
New safety information also suggests that widespread antiseptic use could have an impact on the development of bacterial resistance
Meanwhile Dr. WoodCOCK had this to say:
“Today, consumers are using antiseptic rubs more frequently at home, work, school and in other public settings where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Your useless spawn are not only little weaklings, but you are fomenting their inability to cope.
Jungle is spent, and has little vitriol left for the day. After all, its past 0100GMT. Almost time for high tea at The Palace, bullshit institution that it is. Applause to H&M for attempting to change the rules of the game.
Back to fucking peanuts. What a bogus ass “problem” — likely invented by the CABAL. Let us take a look at some stats, shall we? We already know the obvious : allergies of all ilks are on the rise. But peanut allergies in particular are “in fashion”.
In recent years, a growing number of families have had to grapple with such challenges. An estimated 32 million Americans have food allergies, or nearly 10 percent of the population—10 times the prevalence reported 35 years ago. The severity of symptoms seems to be increasing, too. According to a study released in January by Food Allergy Research & Education (FARE), a Virginia-based nonprofit, insurance claims for anaphylactic food reactions rose 377 percent in the U.S. from 2007 to 2016.
The epinephrine market is expected to exhibit a CAGR of 11.0% during the forecast period (2018 – 2026), attributed to increasing number of generic cost-effective auto-injectors in the market, and strategic support of companies and government agencies for increasing generic epinephrine adoption. Furthermore, pipeline of epinephrine products is increasing and this is expected to fuel the market growth over the forecast period.
Moreover, increasing incidence of anaphylaxis associated with food allergy is driving the market growth. According to a research conducted by the Centers for Disease Control and Prevention (CDC) in 2013, in the U.S., between 1997 and 2011, food allergies among children increased around by 50%.
Moreover, according to the European Academy of Allergy and Clinical Immunology (EAACI), over 17 million people in Europe were affected by food allergy in 2015.
Market growth is attributed to approval and launch of cost effective generic epinephrine products. For instance, in December 2016, Mylan introduced an authorized generic option to EpiPen (epinephrine injection, USP) Auto-Injector with a different packaging and same drug formulation, which was available at 50% lower prices than its branded version.
Some of the major players operating in the global epinephrine market include Mylan N.V., Pfizer, Inc., Teva Pharmaceuticals Industries Ltd., Impax Laboratories, Inc., Kaleo, Inc., Adamis Pharmaceuticals Corporation, Bausch Health Companies, and ALK- Abello A/S.
CABAL: NEW ENGLAND JOURNAL OF MEDICINE HAS BLESSED AR101
But while preventing all food allergies is clearly unrealistic, researchers are making remarkable progress in developing better treatments—therapies that, instead of combating symptoms after they’ve started (like epinephrine or antihistamines), aim to make patients less sensitive to allergens in the first place. One promising approach is oral immunotherapy (OIT), in which patients consume small but slowly increasing amounts of an allergen, gradually reducing their sensitivity.
A study published last year in the New England Journal of Medicine showed that an experimental OIT called AR101, consisting of a standardized peanut powder mixed into food, enabled 67 percent of participants to tolerate a dose equivalent to two peanut kernels—a potential lifesaver if they were accidentally exposed to the real thing. Because OIT itself can trigger troublesome reactions in some patients, however, it’s not for everyone.
Another experimental treatment, sublingual immunotherapy (SLIT) uses an allergen solution or dissolving tablet placed beneath the tongue; although its results are less robust than OIT’s, it seems to generate milder side effects. Epicutaneous immunotherapy (EPIT) avoids the mouth entirely, using a technology similar to a nicotine patch to deliver allergens through the skin. Researchers are also exploring the use of medications known as biologics, aiming to speed up the action of immunotherapies by suppressing IgE or targeting other immune-system molecules.
One downside of the immunotherapy approach is that in most cases the allergen must be taken indefinitely to maintain desensitization. To provide a potentially permanent fix, scientists are working on vaccines that use DNA or peptides (protein fragments) from allergens to reset patients’ immune systems.
CABAL: FASTRACKED BY FDA
The BLA for AR101 was originally accepted in March 2019, with an original review target date of late January 2020. The biologic was previously granted Fast Track and Breakthrough Therapy designations for peanut-allergic children and adolescents aged 4-17 years old. The once-daily peanut allergen therapy gradually desensitizes patients from allergic reactions, symptoms, and anaphylaxis.
Based on the support of the Allergenic Products Advisory Committee (APAC), the US Food and Drug Administration (FDA) is nearer to the approval of the first Biologics License Application (BLA) for a food allergy therapy.
LATEST ON FDA UPDATE
he APAC convened on Friday to weigh the efficacy and safety data of AR101 from Aimmune Therapeutics, which was submitted as part of supporting evidence for the drug’s BLA in March. The committee voted 7-2 in favor of the data supporting the licensure of the investigative therapy as a treatment intended to reduce the incidence and severity of allergic reactions in patients aged 4-17 years.
The data included results from 7 clinical trials—a pair being phase 2 and the other 5 being phase 3. The company is seeking an indication for patients aged 4-17 years old with a confirmed diagnosis of peanut allergy.
One phase 3 trial (ARC003; PALISADE), a double-blind, randomized study including 551 patients aged 4-55 years old with peanut allergy, showed two-thirds (67.2%) of allergen-treated patients aged 4-17 years old were capable of ingesting at least 600 mg of peanut protein without dose-limiting symptoms at 24 weeks.
Investigators evaluated 2 datasets to assess the safety of the therapy among patients 4-17 years old: the controlled safety population of 1001 patients and the integrated population of 812 patients.
Patients treated with AR101 in the pediatric safety population reported an increased rate of allergic reactions (9.4%) and systemic allergic reactions than placebo-treated patients (3.8%). During maintenance, 8.7% of treated patients reported a systemic allergic reaction, compared to just 1.7% of placebo patients. Another 7.7% of treated patients used epinephrine; just 3.4% of placebo patients did.
Investigators also observed a “substantial proportion” of treated patients discontinuing care due to adverse events (9% of pediatric, 14.3% of adult patients in PALISADE). In the controlled safety population, 3 treated patients developed treatment-emergent eosinophilic esophagitis (EoE), as well as some treated patients in follow-up studies.
IF YOU WANT TO HAVE A LAUGH – SHILLS AND MORE SHILLS
“We’re really exctied to see where these treatments go!”
— DORK PATROL
Read the tea leaves. Don’t put grandma in it.Comments »