Alaska Air Group, Inc. is a holding company, which engages in the provision of air transportation services. It operates through the following segments: Mainline, Regional, and Horizon. The Mainline segment includes scheduled air transportation on Alaska's Boeing and Airbus jet aircraft for passengers and cargo throughout the U.S., and in parts of Mexico, Costa Rica and Belize. The Regional segment consists of Horizon's and other third-party carriers’ scheduled air transportation for passengers across a shorter distance network within the U.S. and Canada under capacity purchase agreements (CPA). The Horizon segment encompasses the capacity sold to Alaska under a CPA. The company was founded in 1985 and is headquartered in Seattle, WA.
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- The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive recommendation for EURneffy 1 mg, a needle-free nasal adrenaline spray for treating anaphylaxis in children aged 4 years and older weighing 15-30 kg. - This recommendation extends the existing marketing authorization for EURneffy 2 mg, which was approved in August 2024 for adults and children weighing 30 kg or more. - The approval addresses a significant medical need, as anaphylaxis affects approximately 1 to 761 out of every 100,000 children annually in Europe, with food allergies accounting for more than two-thirds of pediatric cases. - ALK holds exclusive global commercialization rights for the product through a strategic licensing agreement with US-based developer ARS Pharmaceuticals, excluding certain markets including the USA, Australia, New Zealand, Japan, and China.
- ALK experienced regulatory problems in China in 2024, prompting the Danish company to seek a local partner to navigate the challenging market. - The company has formed a strategic partnership with Gensci, which will take over ALK's operations in China and provide market access solutions. - The collaboration extends beyond China, with ALK gaining rights to market Chinese immunotherapy drugs in Western markets, expanding beyond its traditional allergy focus.
- ALK's tree pollen tablet ITULAZAX has been recommended by NICE for use in the UK health system, making it eligible for general reimbursement through the NHS in England, Wales, and Northern Ireland. - This marks ALK's second NICE approval for sublingual allergy immunotherapy products in 2025, following ACARIZAX approval in March, addressing significant underutilization of AIT in the UK compared to other European countries. - The approval comes as scientists warn of an early tree pollen season with higher counts, affecting approximately 16 million people with hay fever in the UK, including 4 million with moderate to severe tree pollen allergy. - NICE published Final Draft Guidance on July 21, 2025, with Final Guidance expected in August, after which NHS systems will be required to implement ITULAZAX in treatment practices.
- ALK and ARS Pharmaceuticals have entered a four-year co-promotion agreement for Neffy, the only FDA-approved needle-free epinephrine nasal spray for treating anaphylaxis, targeting 9,000 US pediatricians. - ALK will deploy a dedicated 60-person pediatric sales force, with ARS Pharma covering most direct costs and offering performance-based revenue sharing when sales exceed certain market share thresholds. - The partnership aims to address significant unmet needs in anaphylaxis treatment, as studies show only half of the 20 million Americans diagnosed with severe allergic reactions maintain active epinephrine prescriptions.
• Industry experts at Reuters Pharma Europe 2025 debated the challenges of pharmaceutical launch sequencing across 27 EU Member States amid ongoing legislative review, highlighting the need for unified pricing strategies. • Panelists proposed differential pricing with confidential rebates adapted to GDP per capita as a potential solution to navigate international reference pricing concerns and potential impacts from U.S. policies like Most Favored Nation. • The Joint Clinical Assessment (JCA) was identified as having significant potential to streamline European market access, though experts emphasized the need for sufficient interaction between companies and decision-makers for successful implementation.
- The FDA has approved ODACTRA®, an under-the-tongue immunotherapy tablet, for treating house dust mite allergies in children aged 5-11 years, expanding its previous indication for ages 12-65. - The approval is based on the largest pediatric allergy immunotherapy Phase 3 trial to date, involving 1,460 children across North America and Europe, demonstrating both efficacy and safety. - This expansion addresses a significant medical need, as over ten million children aged 5-11 globally suffer from uncontrolled respiratory allergies, with house dust mites being a common trigger.
- ALK's sublingual immunotherapy (SLIT) tablet for peanut allergy demonstrated safety and tolerability across multiple doses in a Phase I/II trial. - Based on Phase I/II results, the peanut tablet development is advancing to Phase II to evaluate dose finding and efficacy. - The Phase II trial, involving approximately 125 patients in the USA and Canada, is expected to be completed in 2026, with first patients dosed imminently.
• ALK's pivotal Phase 3 trial (MT-12) evaluating the efficacy and safety of its house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet) in children has been published in _The Lancet Regional Health – Europe_. • The trial confirms earlier results from ALK's adult house dust mite tablet trials and represents the largest pediatric, randomized controlled trial conducted to date with house dust mite allergy immunotherapy. • The house dust mite SLIT-tablet is marketed as ACARIZAX® in Europe, ODACTRA® in the USA, and MITICURE™ in Japan, with ongoing regulatory processes to secure approvals for children in Europe and North America. • ALK and its partner Torii have completed 14 Phase 3 children trials with SLIT-tablets, enrolling pediatric populations with respiratory allergies induced by various pollens and house dust mites.
- The FDA has approved ALK's AccuTest line of allergy skin testing devices, including AccuTest-1, AccuTest-8, and AccuTest-10, along with allergen trays, for enhanced allergy diagnosis. - AccuTest devices feature design improvements like smaller tine lengths and enhanced ergonomics to improve accuracy and minimize patient discomfort during allergy testing. - The AccuTest allergen trays, compatible with both single and multi-head devices, include features such as an airtight locking mechanism and a non-slip rubber bottom for stability and accuracy. - ALK emphasizes that identifying allergen triggers through effective testing is the first step toward managing the significant clinical and economic burdens of chronic allergies.
