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Tagged With "clinical trials"

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Re: Food Allergy Test: What Does It Mean?

KFA Medical Advisors ·
I'd like to thank everyone for posting such wonderful comments. I'd like to address two topics that were mentioned so far: 1. Eczema and food allergies can be a very difficult and complicated topic, which may need it's own blog post in the future. While I can't give out specific medical advice in this forum, I am happy to help elaborate a bit more. In general , the majority of children with eczema do not have an external cause of their skin condition. Eczema is a genetic, chronic, skin...
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Early-Intervention Leads to a High Rate of Peanut Oral Immunotherapy (OIT) Success

Kids With Food Allergies ·
Low doses of peanut early in life may lead to long-term allergy control   (Press Release)   Houston, TX – An early-intervention oral immunotherapy (EI-OIT) trial for peanut allergy shows promising results and could represent a new,...
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Epinephrine Auto-Injectors for Infants and Toddlers to Be Available May 1

KFA News Team ·
Kaléo, a privately-held pharmaceutical company, today announced that AUVI-q® (epinephrine injection, USP) 0.1 mg will be available nationwide by prescription beginning May 1, 2018. AUVI-q 0.1 mg is indicated for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and toddlers weighing 16.5 to 33 pounds (7.5 to 15 kilograms).
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Epinephrine Nasal Spray Gets Fast Track Status From FDA as a Possible Treatment for Life-Threatening Food Allergy Reactions

KFA News Team ·
INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s epinephrine nasal spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.
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FDA Accepts Application for Viaskin Peanut Patch for Review

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin® Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts.
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FDA Acknowledges Study on Early Introduction of Peanut for Allergy Prevention

Kids With Food Allergies ·
After conducting a systematic review of the available scientific evidence, the U.S. Food and Drug Administration has determined that it intends to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age.
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FDA Allows Peanut Immunotherapy Treatments to Advance

KFA News Team ·
  The Food and Drug Administration (FDA) agreed to expedite the review of a specially formulated peanut product. The peanut product, called AR101, is being studied as a potential allergy treatment. The status was granted after the company...
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FDA Approves New Flu Treatment

KFA News Team ·
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
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FDA Fast Tracks Designation for Viaskin Milk for the Treatment of Cow’s Milk Protein Allergy

KFA News Team ·
Kids With Food Allergies is sharing this press release from DBV Technologies . This is not an endorsement of the content contained in the press release. Speak with your physician if you have any questions. [PRESS RELEASE] Wednesday, September 21, 2016 DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk for the Treatment of Cow’s Milk Protein Allergy DBV first to announce Fast Track designation for IgE-mediated CMPA; Viaskin Milk is currently being investigated in a Phase...
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FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Kids With Food Allergies ·
The Food and Drug Administration agreed to review a skin patch for peanut allergy on an expedited basis following positive results of recent clinical trials, the company said Thursday.   DBV Technologies said that the FDA granted its Viaskin...
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Breaking News: FDA Approves Palforzia, a Ground-Breaking Peanut Allergy Oral Immunotherapy Treatment

KFA News Team ·
On Jan. 31, 2020, the U.S. Food and Drug Administration (FDA) announced its approval of Aimmune Therapeutics’ peanut treatment, Palforzia, for children ages 4 to 17. This is big news for the food allergy community. Food allergies put a significant mental, social and financial burden on families. Until now, strict avoidance has been the only way to avoid allergic reactions. Palforzia may give many families managing peanut allergies more freedom and greater quality of life.
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Can We EAT Our Way to Prevention of Food Allergies?

KFA News Team ·
We now have very strong evidence that early introduction of peanut can prevent the development of peanut allergy. Does this apply to other allergenic foods? The authors of the newest research study, Enquiring About Tolerance (EAT) sought to answer this question.
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Clinical Trial Will Test Whether Omalizumab Can Reduce Food Allergy Reactions

KFA News Team ·
While experimental desensitization strategies are available in research settings, people with food allergies must avoid known allergens and are advised to carry injectable epinephrine to prevent potentially life-threatening allergic reactions caused by accidental exposures. To help alleviate this risk, a new study to evaluate an experimental treatment for food allergy launched today.
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DBV Announces Phase III Trial Results for Viaskin Peanut

KFA News Team ·
DBV Technologies Announces Publication of Detailed Phase III Trial Results Evaluating Viaskin Peanut as a Novel Treatment for Peanut Allergy in The Journal of the American Medical Association
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DBV Resubmits Viaskin Peanut Allergy Treatment to FDA

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.
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Help Others See Beyond Food Allergies During National Asthma and Allergy Awareness Month and Food Allergy Awareness Week

Kids With Food Allergies ·
Each May since 1984, the Asthma and Allergy Foundation of America (AAFA) has declared May to be National Asthma and Allergy Awareness Month. This month is dedicated to teaching others about asthma and allergies to create more awareness and understanding. Kids With Food Allergies (KFA) is a division of AAFA. May 12-18, 2019, is also Food Allergy Awareness Week. During this week, we focus on spreading information about what it’s like to manage food allergies and raise awareness about anaphylaxis,
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Aimmune Therapeutics Reports Positive Results From Peanut Immunotherapy Studies

KFA News Team ·
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, announced clinical data presented today at the 2017 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Atlanta. The presentations included Phase 3 screening data and Phase 2 adherence data from Aimmune’s AR101 program. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
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Food Allergy Research Roundup 2017 Quarter 1

KFA News Team ·
Kids With Food Allergies will recap some of the top research in food allergies every three months. Here is a look at studies reported between January and March. Read about teens and food allergy, peanut allergy, secondhand smoke and more.
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Food Allergy Research Update: Viaskin Study for Peanut Allergy

KFA News Team ·
Press Release: Consortium of Food Allergy Research Completes Recruitment of NIH-sponsored CoFar6 Phase II Trial with DBV's Viaskin(r) Peanut in Treatment of Peanut Allergy Leading US centers in food allergy involved in an NIH-funded CoFAR6 study,...
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SYMJEPI Pre-Filled Epinephrine Injection Available at U.S. Pharmacies

KFA News Team ·
Sandoz Inc. (Sandoz), a Novartis division, today announced the US retail launch of SYMJEPI™ (epinephrine) 0.3 mg and 0.15 mg Injections, making both the adult and pediatric doses immediately available in local pharmacies across the nation.
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The LEAP Trial 12 Months Later: Are We Ready to LEAP-On Peanut Allergy?

KFA News Team ·
Researchers announced results from the second phase of a landmark food allergy study, with the data showing that feeding peanuts to babies at high risk for developing the allergy sharply cuts their chance of becoming allergic by age 5.
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Three-Injection Immunotherapy for Grass Pollen Well Tolerated in Teens

Kids With Food Allergies ·
Three ultrasound guided lymph node injections safe in teens   (Press Release)   Houston, TX – Researchers have new evidence that grass-pollen allergies can be safely treated using American extracts injected into a lymph node...
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Treatment for Milk Allergy Shows Positive Results in Clinical Trial

Kids With Food Allergies ·
DBV Technologies today announced preliminary results from Part B, or Phase II, of a Phase I/II study evaluating the efficacy and safety of three dose regimens of Viaskin Milk (150 µg, 300 µg, 500 µg) in 198 patients for the treatment of IgE-mediated cow's milk protein allergy (CMPA). The MILES (Milk Efficacy and Safety) study was designed to determine a safe and effective dose in two age groups.
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Two Peanut Allergy Treatment Trials Move Forward

Kids With Food Allergies ·
Kids With Food Allergies is sharing these press releases from Aimmune Therapeutics and DBV Technologies to bring you the latest research news quickly. [PRESS RELEASE] Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy BRISBANE, Calif.– (BUSINESS WIRE) – Feb. 20, 2018 – Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced...
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Peanut Allergy Oral Immunotherapy: Is Earlier Better?

KFA News Team ·
“Peanut allergy can have an adverse impact on quality of life for the child and family. Severe allergic reactions can occur with just a tiny ingestion of peanut allergen. A new NIH study provides encouraging news that children may be successfully treated with OIT for peanut allergy at a very young age.” – Lynda Mitchell, chief operating officer of the Asthma and Allergy Foundation of America What health issue did the study examine? We currently have no effective means to cure or treat food...
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Peanut Allergy Patch Study Misses Its Main Goal in Third Phase

Kids With Food Allergies ·
Kids With Food Allergies is sharing this press release from DBV Technologies to bring you the latest research news quickly. [Press Release] DBV Technologies Announces Topline Results of Phase III Clinical Trial in Peanut Allergic Patients Four to 11 Years of Age DBV Technologies (Euronext: DBV – ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced topline results from the PEPITES (Peanut EPIT Efficacy and Safety) Phase III trial evaluating the safety and efficacy of Viaskin Peanut...
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Peanut Patch Continues to Show Promise

KFA News Team ·
After the success of the yearlong double-blind, placebo controlled randomized Phase IIb trial for a peanut patch, known as Viaskin® Peanut, researchers continued the trial two more years in an open label extension to ascertain the effect of long-term treatment.
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Peanut Patch Shows Positive Results During Clinical Trial

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure.
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Possible Epinephrine Nasal Spray May Offer New Option for Those With Food Allergies

KFA News Team ·
INSYS Therapeutics, Inc., announced today that it has started a proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, with the enrollment of the first patient.
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Promacta® Oral Suspension Recalled for Possible Peanut Contamination

KFA News Team ·
Novartis today announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.
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Q&A: What Does Omalizumab Mean for Oral Immunotherapy Treatment for Multiple Food Allergies?

Kids With Food Allergies ·
Oral immunotherapy (OIT) is a proposed method to treat food allergy. It is currently in late-stage clinical trials (peanut specifically). It is expected to be approved by the U.S. Food and Drug Administration (FDA) soon. There have been many clinical trials for specific food OIT alone and with medicines, such as omalizumab, as reported in this study.
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Reducing Risk of Peanut Allergy – A Review of New Guidelines (Video and Resources)

Kids With Food Allergies ·
The new guidelines recommend introduction of peanut-containing foods to infants as early as 4 and 6 months of age. How peanut-containing foods should be introduced to infants depends on the infant’s risk level.
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Sublingual (Under-the-Tongue) Immunotherapy Shows Promise in Treating Peanut Allergy

Kids With Food Allergies ·
Peanut Therapy Shows Promise in Treating Peanut AllergyNIH-Funded Clinical Study is One of the First to Evaluate Sublingual Immunotherapy as a Peanut Allergy Treatment FOR IMMEDIATE RELEASE Monday, Jan. 7, 2013 WHAT: A new study supported by the...
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Landmark Study May Change How We Feed Peanut Butter To Infants

Kids With Food Allergies ·
High-Risk Infants Fed Peanuts Developed Allergy At Lower Rate Than Other Babies - Study May Pave Way for New Prevention Strategies   Feeding peanut butter to infants at risk for developing peanut allergies prevented those same babies from...
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Late-Breaking Peanut Patch Phase IIb Trial Results Unveiled at AAAAI Annual Meeting

Kids With Food Allergies ·
Epicutaneous Immunotherapy (EPIT) introduces new way to treat peanut allergies   (Press Release)   Houston, TX – A team of researchers unveiled the results of their highly anticipated multi-national, double-blind, placebo controlled...
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Macaroons Recipe Free of Milk and Eggs (Wheat-Free Option)

KFA Food Bloggers ·
Egg-Free, Milk-Free Macaroons by Lisa (Monster-Mom) I made Lynn's Coconut Macaroons for my son's coconut trial. They were so good I had to hide the bag from myself! I replaced the agave with Lyle's golden syrup, and used potato starch...
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The Future of Food Allergy: Developing New Treatments

KFA Medical Advisors ·
The future of food allergy: developing new treatments   by Michael H. Land, MD FAAAAI   I'm the father of a food allergic child. If you're reading this, I am guessing you or someone close to you has a food allergy. The minute you found out...
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NIH-Funded Study Shows Peanut Allergy Prevention Strategy Is Nutritionally Safe

Kids With Food Allergies ·
Early-Life Peanut Consumption Does Not Affect Duration of Breastfeeding or Children’s Growth and Nutrition
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Omalizumab Makes Oral Immunotherapy Treatments More Effective

Kids With Food Allergies ·
Combining a 16-week initial course of the medication omalizumab with oral immunotherapy (OIT) greatly improves the efficacy of OIT for children with allergies to multiple foods, new clinical trial findings show. After 36 weeks, more than 80 percent of children who received omalizumab and OIT could safely consume two-gram portions of at least two foods to which they were allergic, compared with only a third of children who received placebo and OIT.
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Oral Immunotherapy for Food Allergy: Not Ready for Prime Time

Kids With Food Allergies ·
Oral Immunotherapy for Food Allergy: Not Ready for Prime Time Hugh A Sampson, MD, of Mount Sinai School of Medicine and the Jaffe Food Allergy Institute, explains why oral immunotherapy (OIT) for food allergy may be premature and its safety and...
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Which Common Cold Viruses Trigger Inner-City Children’s Asthma Flares?

Kids With Food Allergies ·
Researchers identify common cold species present during asthmatic exacerbations, a first step towards improving asthma outcomes   (Press Release)   Houston, TX – Researchers are hoping to learn more about the rhinovirus (RV) by...
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Study Shows Boiled Peanut Immunotherapy May Be Effective as an Allergy Treatment

KFA News Team ·
A new oral immunotherapy (OIT) treatment using boiled peanut has been found to be both effective and safe, following a Phase 2b/3 randomized controlled trial.
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Re: Steamed Rice Flour Cake Made with Few Ingredients

Monster Mom ·
THat is what I was afraid of. I worked with rice in our last trial, so I KWIM. I also have found that potato treat the same tends to be a lump. Unfortunately, no, we don't have anything else for flour. HOwever, I have found that when things go ary, DS still doesn't mind trying them and we DO find "new foods". So thanks!! If I go for it, I"ll let you know how it turns out. Lisa
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Re: The Future of Food Allergy: Developing New Treatments

LinzStein ·
Great overview! KFA- is there any additional info about the use of Allergen non-specific therapies for EoE? What about accupressure or homeopathics? Thank you!
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Re: The Future of Food Allergy: Developing New Treatments

Kathy P ·
I haven't seen anything specific regarding those. You could check in the News & Research forum.
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Re: The Future of Food Allergy: Developing New Treatments

franandpaul ·
Thanks for this great overview!
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Re: The Future of Food Allergy: Developing New Treatments

sageone ·
This gives me hope that my child will eventually be allergy free and his life will not be in danger from a simple item of food! Thank you so much for this great article in layman terms so that we parents can understand it!
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Re: The Future of Food Allergy: Developing New Treatments

EAH123 ·
What a great overview! Thank you!
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Re: The Future of Food Allergy: Developing New Treatments

Jessica Dabler Martin ·
Fantastic overview of what is on the horizon. Thank you!
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Re: The Future of Food Allergy: Developing New Treatments

Sandra Sebastian ·
Hi Michael, Very interesting for us to read as I have more than one grandchild with food allergies! Congratulations on all your accomplishments and studies. Love from us all, your old Oxford neighbour!
 
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