Adrenaline

First Aid Pro Launches Comprehensive First Aid Certification and CPR Training Courses

Retrieved on: 
Monday, February 19, 2024

Southport, Queensland--(Newsfile Corp. - February 19, 2024) - First Aid Pro, a leading provider of first aid and CPR training, is pleased to announce the launch of their comprehensive first aid courses and CPR Training classes that are meant to teach people and groups how to save lives.

Key Points: 
  • Southport, Queensland--(Newsfile Corp. - February 19, 2024) - First Aid Pro, a leading provider of first aid and CPR training, is pleased to announce the launch of their comprehensive first aid courses and CPR Training classes that are meant to teach people and groups how to save lives.
  • First Aid Pro recognizes the importance of such skills and is committed to delivering top-notch training to individuals and workplaces across Australia.
  • First Aid Pro offers flexible training options, including in-person courses at its training center and customized on-site training for businesses and organizations.
  • To enroll in the First Aid Certificate and CPR Training courses or learn more about First Aid Pro's offerings, please visit https://www.firstaidpro.com.au/ .

ARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy® Investor Day

Retrieved on: 
Thursday, March 7, 2024

The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.

Key Points: 
  • The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.
  • Of the patients that do fill their prescription, 80-90% either do not carry or use their treatment as indicated.
  • In late-February, the Company announced positive clinical data from a Phase 2 trial evaluating neffy in adults with chronic spontaneous urticaria.
  • The webcast replay and accompanying slides from today’s investor event may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website.

Aquestive Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 5, 2024

Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.

Key Points: 
  • Aquestive received positive feedback in October 2023 from the U.S. Food and Drug Administration (FDA) on the Company's pivotal Phase 3 Pharmacokinetic (PK) clinical protocol for Anaphylm.
  • Aquestive commenced dosing in December 2023 in the Phase 3 pivotal PK clinical study of Anaphylm.
  • Non-GAAP adjusted EBITDA loss was $2.8 million in the fourth quarter 2023, compared to a $9.6 million loss in the fourth quarter 2022.
  • During the fourth quarter 2023, the Company accessed capital net proceeds of $3.7 million under its "At-the-Market" (ATM) facility.

ARS Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study

Retrieved on: 
Monday, February 26, 2024

Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

Key Points: 
  • Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
  • “Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis.
  • neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients.
  • This would follow the anticipated FDA approval of neffy for allergic reactions (Type I) including anaphylaxis in the second half of 2024.

ARS Pharmaceuticals to Host Virtual neffy® Investor Day on March 7, 2024

Retrieved on: 
Thursday, February 22, 2024

SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that it will host a virtual investor day highlighting neffy® (epinephrine nasal spray) on Thursday, March 7, 2024, at 1:00 p.m.

Key Points: 
  • SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced that it will host a virtual investor day highlighting neffy® (epinephrine nasal spray) on Thursday, March 7, 2024, at 1:00 p.m.
  • The event will include presentations by members of the ARS management team and by two distinguished allergists:
    A live question and answer session will follow the formal presentations.
  • The neffy Investor Day webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website.
  • A replay of the webcast will be archived on the Company’s website for 90 days.

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Community Health Systems Partners With Mark Cuban Cost Plus Drug Company to Address the Rising Cost of Drugs and Potential Drug Shortages

Retrieved on: 
Thursday, March 7, 2024

Community Health Systems, Inc. (NYSE: CYH) (CHS) will become the first national healthcare system to purchase select pharmaceutical supplies from Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) as part of a new, collaborative relationship that promises to bring high-quality, lower cost drugs into the hospital setting.

Key Points: 
  • Community Health Systems, Inc. (NYSE: CYH) (CHS) will become the first national healthcare system to purchase select pharmaceutical supplies from Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) as part of a new, collaborative relationship that promises to bring high-quality, lower cost drugs into the hospital setting.
  • Drug shortages – Cost Plus Drugs is focused on manufacturing drugs that are often in limited supply, threatening patient treatment and outcomes when shortages occur.
  • CHS and Cost Plus Drugs are working together to identify, prepare for, and mitigate potential future drug shortages in the hospital setting.
  • “Community Health Systems has stepped forward to consider important issues related to drug supply, drug costs, patient care and outcomes,” said Alex Oshmyansky, MD, PhD, Chief Executive Officer of Mark Cuban Cost Plus Drug Company.

Mesa Science Associates Contributes to Study Demonstrating Efficacy of Intranasal Spray at Treating Anaphylaxis

Retrieved on: 
Tuesday, February 27, 2024

FREDERICK, Md., Feb. 27, 2024 /PRNewswire-PRWeb/ -- Kenneth Dretchen, PhD, of Mesa Science Associates, in collaboration with researchers from Bryn Pharma LLC, Celerion Inc., and Allucent, recently published an article in the Journal of Allergy and Clinical Immunology: Global entitled "A 13.2 mg epinephrine intranasal spray demonstrates comparable pharmacokinetics, pharmacodynamics, and safety to a 0.3 mg epinephrine autoinjector."

Key Points: 
  • The current treatment option of acute anaphylaxis via intramuscular administration of epinephrine (e.g., EpiPen) poses a number of issues.
  • The device itself can be difficult to obtain due to its high cost and limited availability in many countries.
  • The published study was conducted to demonstrate that an intranasal spray is a viable alternative.
  • Mesa Science Associates Inc. is a veteran-owned small business located within the Frederick Innovative Technology Center Inc. (FITCI) at 321 Ballenger Center Drive, in Frederick, Md.

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

Retrieved on: 
Friday, February 16, 2024

Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Key Points: 
  • Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
  • "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
  • Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur.
  • Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.

Aquestive Therapeutics to Present Anaphylm™ (epinephrine) Sublingual Film Pharmacokinetic and Pharmacodynamic Data at the 2024 AAAAI Annual Meeting

Retrieved on: 
Thursday, February 15, 2024

The clinical trial data show that epinephrine delivered via orally administered Anaphylm™ (epinephrine) Sublingual Film is comparable to epinephrine delivered via autoinjector or manual intramuscular (IM) injection.

Key Points: 
  • The clinical trial data show that epinephrine delivered via orally administered Anaphylm™ (epinephrine) Sublingual Film is comparable to epinephrine delivered via autoinjector or manual intramuscular (IM) injection.
  • Anaphylm candidate, with the potential to be the first and only non-invasive, orally delivered epinephrine product, demonstrates clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of severe allergic reactions, including anaphylaxis.
  • A Phase 3 pivotal study for Anaphylm is currently underway with topline data anticipated in the first quarter of 2024.
  • “With discovery and innovation as key themes of this year’s meeting, we are eager to present our latest clinical trial data at the upcoming AAAAI Annual Meeting,” said Dan Barber, Aquestive President and Chief Executive Officer.