December 3rd 2024
Aquestive Therapeutics announced positive feedback from the FDA this week that keeps NDA planning for the novel epinephrine product on solid ground.
November 15th 2024
The target action date for the FDA decision is April 18, 2025, according to Sanofi and Regeneron.
November 8th 2024
A decision on ending use of oral phenylephrine as a nasal decongestant in OTC products will be made following public comment on FDA's proposed order.
October 28th 2024
ACAAI 2024. Two studies here showed that anaphylaxis protocols for EMS are outdated in many states and that many patients don't know how to use epinephrine.
September 11th 2024
The needle-free nasal spray, if approved, would be the first new administration method for epinephrine in young children in 35 years.
Expert Illustrations & Commentaries™: Picturing the Potential Role of OX40 and OX40L Inhibitors in Atopic Dermatitis
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Community Practice Connections™: Navigating a New Era of Food Allergy Management
New Data on Needle Free Epinephrine Spray Presented at ACAAI 2024
A summary of new data presented at the 2024 American College of Allergy, Asthma & Immunology Annual Scientific Meeting.
7 Drugs Approved for Primary Care: Q3 2024
Updated mRNA COVID-19 vaccines, the first orally disintegrating tablet approved for pregnancy prevention, and 5 more.
FDA Approves Neffy as First Nasal Spray for Allergic Reactions: Daily Dose
Your daily dose of the clinical news you may have missed.
Neffy, First Needle-Free Epinephrine, Fills a Deep Need for Patients, says Allergy Expert
The approval of neffy (epinephrine nasal spray) could help individuals and caregivers act sooner and feel safer treating a type 1 allergic reaction.
FDA Approves First Intranasal Epinephrine for Emergency Treatment of Allergic Reactions
neffy (epinephrine nasal spray) is the first alternative to epinephrine administered by autoinjector or syringe and is comparable in efficacy to the gold standard.
Topline PK Data Released on Self-Administered Epinephrine Sublingual Film for Severe Allergy
PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.
ARS Pharma Submits Response to FDA Complete Response Letter for neffy (epinephrine nasal spray)
Positive findings from a repeat dosing study of neffy under nasal allergen challenge conditions will support a potential PDUFA date of October 2, 2024, the company said.
Optinose Xhance approved by FDA as first medical therapy for CRS
Now FDA approved, Optinose’s Xhance is the first nonsurgical option for chronic rhinosinusitis both with and without nasal polyps.
Neffy May be Safe, Effective for Treatment of Urticaria Flares: Daily Dose
Phase 3 Findings on Neffy for Pediatric Patients with Severe Allergies: A Conversation with Motohiro Ebisawa, MD, PhD
Dr Ebisawa details the findings he recently presented at the 2024 AAAAI annual meeting, including adverse events and next steps for the study.
Needle-free Epinephrine Delivery: Perceptions of Physicians, Patients, and Caregivers
AAAAI 2024. Needle phobia is just one of the barriers to not just using an epinephrine autoinjector but to carrying one at all, according to 2 sets of surveys findings.
New Data Suggest neffy May be Safe, Effective for Treatment of Urticaria Flares
AAAAI 2024. In patients with treatment-resistant chronic spontaneous urticaria, neffy 1 mg and 2 mg resulted in improvement in itch, hives, urticaria, and erythema scores 5 minutes after dosing.
Neffy Generates Favorable PK/PD Data Under Nasal Allergen Challenge in Repeat Dosing Study Requested by FDA
neffy (epinephrine nasal spray) delivered a PK and PD profile greater than or similar to that of IM epinephrine after extreme nasal challenge, reports ARS Pharmaceuticals.
EoE in Children Treated with Dupilumab More Severe at Diagnosis, Study Finds
AAAAI 2024. Dupilumab-treated eosinophilic esophagitis in children was also more often associated with comorbid asthma, according to researchers.
New neffy Data on Clinical Efficacy Presented at 2024 AAAAI Annual Meeting
AAAAI 2024. New data on neffy (epinephrine nasal spray) include the first report of efficacy after oral food challenge in a pediatric population at risk for anaphylaxis.
Dupilumab Effective Up to 5 Years in Adults with Moderate-to-Severe Atopic Dermatitis in Open-Label Extension Study
AAAAI 2024. Reduction of AD signs and symptoms was significant among approximately half of study participants at 4 weeks and continuously rose through week 260, investigators report.
First Study of Oral Mucosal Immunotherapy for Peanut Allergy Elicits Robust Immunologic Response in Adults
AAAAI 2024. Oral mucosal immunotherapy delivered via metered-dose toothpaste produced a statistically significant increase in IgG4 and a decrease in IgE/IgG4 ratio.
Tezepelumab Demonstrates Sustained Post-Treatment Reductions in CSU Disease Activity, Inflammatory Markers
AAAAI 2024. The effects, seen 18 to 20 weeks after discontinuation of tezepelumab, suggest a persistent effect of thymic stromal lymphopoietin (TSLP) blockade in CSU.
Omalizumab Granted First FDA Indication for Children and Adults with Multiple Food Allergies
The OUtMATCH trial showed that individuals as young as age 1 year could tolerate small amounts of peanut and other allergens without an allergic reaction.
Takeda Announces Approval of First Oral Therapy for Eosinophilic Esophagitis
Budesonide oral suspension is the first oral therapy for EoE and represents a needed option in the category, offering flexibility for both patients and clinicians.
Tezepelumab Effective in Severe Asthma Cohorts Stratified by Age at Onset, Inflammatory Phenotype, and Allergen Sensitization
AAAAI 2023. The TSLP inhibitor was superior to placebo in 2 post hoc analyses of the PATHWAY and NAVIGATOR clinical trials.
Fluticasone Exhalation Delivery System Reduced Exacerbations, Need for Antibiotics in Patients with Chronic Sinusitis
IDWeek 2022: New data show a greater than 60% reduction in acute exacerbations and need for antibiotics in patients with CS who used fluticasone propionate nasal spray.
Chronic Sinusitis Flares Reduced by 66% in Pooled Analysis of Optinose ReOpen Program Data
For patients with chronic sinusitis, disease exacerbations often require use of antibiotics and steroids, in addition to medical office visits, all of which impact quality of life.
FDA Approved Dupilumab as the First Treatment for Eosinophilic Esophagitis
Dupilumab is approved for the treatment of eosinophilic esophagitis in patients aged ≥12 years weighing at least 40 kgs.
7 New Drugs Approved for Primary Care: Q1 2022
Another new COVID-19 vaccine, the first and only once-daily amphetamine transdermal patch approved for the treatment of ADHD, and 5 more.
Novel Agent for Severe Asthma Halves Exacerbation Rates Across Respiratory Comorbidities
Tezepelumab, a TSLP inhibitor, reduced asthma exacerbation rates in patients with severe uncontrolled disease across a range of respiratory comorbidities.
Dupilumab Significantly Decreased Itch and Hives in Patients with Chronic Spontaneous Urticaria
Dupilumab significantly reduced itch and hives in patients with H1 antihistamine-resistant chronic spontaneous urticaria, according to new research.
Severe Asthma Research Recap: 8 Updates for Primary Care
Research summaries on GINA revisions, a steroid-reduction algorithm, factors that predict asthma exacerbation risk, and more.
Severe Uncontrolled Asthma: 5 Questions on Key Characteristics
Optimal use of biologic therapy for severe uncontrolled asthma rests on understanding of the disease itself. Try this quick quiz to test your knowledge.
Atopic Disease, Particularly Asthma, Linked to Decreased Risk of COVID-19 Infection in UK Adults
Adults with atopic disease and asthma had a 38% decreased risk of COVID-19 infection, according to a new UK study.