DBV Technologies, the firm that received the Food and Drug Administration’s (FDA) Breakthrough Therapy Designation for their peanut patch in April, issued a press release stating that the board overseeing their milk patch Phase I trial found no safety concerns and is recommending the therapy progress on to Phase II.
Phase I studies focus on the safety of a new therapy while Phase II studies focus on a therapy’s efficacy. Pending a review of the Phase I data by the FDA and approval of the proposed Phase II protocol, the firm expects to continue on to the Phase II study in the second half of 2015.
DBV describes Viaskin® as “an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.” In other words, the patch therapy introduces increasing quantities of an allergen through the skin and by doing so desensitizes the individual to that allergen.
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A team from the University of Pennsylvania identified 233 quick-service restaurants in the Center City District of Philadelphia and conducted a study of the 187 that agreed to participate. Staff were asked to respond to a tablet-based survey that assessed their knowledge, attitudes, and practices related to food allergy.
The results were both heartening and disturbing: “Despite their high motivation to help food allergic patrons, respondents knew little about how to prevent or respond to adverse events,” as quoted in the summary on the American Public Health Association (APHA) website.
Food Allergy Research and Education (FARE) announced today the launch of the FARE Clinical Network. The effort aims to accelerate the development of therapies and promote best practices for the care of people suffering with food allergies.
FARE has pledged an investment of $2 million annually to the network, whose inaugural members are:
- Ann & Robert H. Lurie Children’s Hospital of Chicago
- Arkansas Children’s Hospital Research Institute
- Boston Children’s Hospital
- Children’s Hospital Colorado
- Children’s Hospital of Pittsburgh of UPMC
- Children’s Mercy Kansas City
- Children’s National Health System
- Cincinnati Children’s Hospital Medical Center
- Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai
- Joe DiMaggio Children’s Hospital – a facility of Memorial Healthcare System
- MassGeneral Hospital for Children (Boston)
- National Jewish Health (Denver)
- Rady Children’s Hospital/University of California, San Diego
- Riley Hospital for Children at IU Health
- Sean N. Parker Center for Allergy Research at Stanford University
- Texas Children’s Hospital Food Allergy Program, Baylor College of Medicine
- The Children’s Hospital of Philadelphia
- The Northwest Asthma and Allergy Center (Seattle)
- The University of Chicago Medicine
- UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill
- University of Arizona College of Medicine – Tucson
- UT Southwestern Medical Center and Children’s Medical Center Dallas
Member centers will also contribute to a national food allergy patient registry and biorepositories.
In a study of discharge data collected over 5 years from over 200 hospitals in Illinois, it was determined that emergency room visits and hospitalizations of children with severe food allergies rose an average of 30% each year between 2008 and 2012.
The study, led by Dr. Ruchi Gupta, professor of pediatrics at Northwestern University Feinberg School of Medicine and attending physician at Ann & Robert H. Lurie Children’s Hospital of Chicago, focused on children that suffered anaphylaxis, a potentially fatal allergic reaction.
Previously, white children and those from higher-income families were affected most by food allergies, but the study shows that the rates of Hispanic, African American and lower-income children are skyrocketing as well.
“This study shows that severe food allergies are beginning to impact children of all races and income. This is no longer primarily a disease of children who are white and/or from middle-to-high income families. Nobody is immune to it,” said Dr Gupta.
On Wednesday, three senate democrats issued a letter to the Food and Drug Administration (FDA) urging the authority to issue a rule requiring manufacturers to label for the presence of sesame.
Sesame – though it is estimated that several hundred thousand Americans are allergic to the seed – is not recognized as an allergen under current FALCPA labeling rules, and so is often hidden under other ingredient names such as “tahini” or “natural flavoring”.
To quote the letter issued by Senators Chris Murphy (D-CT), Richard Blumenthal (D-CT) and Edward Markey (D-MA):
Without required uniform labeling of the presence of sesame, consumers with this serious allergy have no way of protecting themselves or their family members from its potentially life-threatening consequences. As Congress recognized when it passed FALCPA (the Food Allergen Labeling and Consumer Protection Act of 2004), accurate and comprehensive allergen labeling is essential.
We at SnackSafely.com wholeheartedly endorse the senators’ efforts to have sesame added to the list of eight allergens recognized by FALCPA, currently peanuts, tree nuts, milk, eggs, wheat, soy, fish and shellfish. We urge the FDA to also consider adding mustard and corn to the list as these are also major allergens that concern many families coping with food allergy.
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If you currently receive health insurance from a policy obtained via the federally run healthcare exchange, you can breathe a sigh of relief. The Supreme Court voted 6-3 to allow subsidies that help poor and middle class families buy health insurance.
The ruling in the King v Burwell case will allow a major provision of President Obama’s Affordable Care Act to stand thus preserving an important source of health insurance for millions.
On Monday, the Maine legislature voted to override a veto of bill HP0776 by Republican Governor Paul LePage. The new law, entitled “An Act To Expand Public Access to Epinephrine Autoinjectors”, allows for stock epinephrine to be made available in places of public accommodation beyond schools, such as restaurants, shopping malls, etc.
Yesterday, Ohio State Rep Dr Terry Johnson published an opinion piece in the Highland County Press stating that the voluntary school stock epinephrine legislation he sponsored has already saved the lives of two children in the same Akron area school district. Both children, one allergic to peanuts, the other to pineapple, were administered epinephrine by a trained staff member when it became apparent they were suffering anaphylactic reactions.
In the same article, Johnson announced that Rep Christina Hagan has introduced a bill in the Ohio House to expand access to stock epinephrine to additional places of public accommodation beyond schools.
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We are pleased to announce a number of new products from two members of our Manufacturer Partnership, but before we do, here’s a few changes we made to better accommodate them.
First, we added a new category: Health Foods and Supplements. While it’s true that many partner products are organic, non-GMO and might be considered health foods, this category is reserved for specific products the average consumer might consider “nutrition boosters”. (Though many of them are also used as basic cooking and baking ingredients.)
Second, we made a change to the Safe Snack Guide to match how we group products in Allergence, our product screening service: we split Baking Chocolate and Chocolate Chips into a separate category from Baking/Flours/Mixes to make it a bit easier to find the products you’re looking for.
On to the new products:
Red Plate Foods, a family owned business located in Oregon known for their delicious Top-8 free vegan cookies and muffins, has introduced a new line of nut-free (worry-free) granolas. Click here to learn more about Red Plate Foods and their products. [The owner of Red Plate Foods, Becca Williams, recently contributed a wonderful article explaining what you can do to encourage your local market to stock more Free From products entitled: “Editorial: Food Allergy Shoppers, Speak Up!“]
Giddy Yoyo, a company based in Ontario specializing in raw, organic, nutrient dense foods, has extended their line of organic chocolate and cacao products and added a number of health foods and supplements, including frozen organic wheatgrass juice and spirulina powder. Click here to learn more about Giddy Yoyo and their products.
Running a small start-up that makes delicious Top-8 allergen-free, vegan, GMO-free muffins, cookies, and now granola, Becca knows what she’s up against when trying to get her products into stores that cater to standard fare.
The FARE Walk for Food Allergy is a series of family-friendly events that take place in communities nationwide to help fund FARE’s mission: foster food allergy education, advocacy, awareness and research. Walkers and teams join in personal fundraising efforts in their communities and each walk celebrates the generous support given to those living with food allergies.
Here follows a schedule of the remaining events for 2015. Click on a location to find out more and register your team. (Or join Team SnackSafely.com at the Ridgewood, NJ walk on October 25th!)
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