DALA

Arhaus Presents Outdoor 2024 Collection

Retrieved on: 
Montag, März 18, 2024
Umbrella, Element, DALA, Inside Out Music, Rotation, ARHS, Relaxation, Beauty, Wind, Life, Collection, Coffee, Primrose, Bal Harbour, Florida, DEDON, Hand, Table, Weather, Furniture

BOSTON HEIGHTS, Ohio, March 18, 2024 (GLOBE NEWSWIRE) -- Arhaus (NASDAQ: ARHS), a leader in artisan-crafted and responsibly sourced home furnishings, reveals its Outdoor 2024 Collection, ‘Echoes.’ Showcasing new silhouettes in striking all-weather materials and durable performance fabrics, ‘Echoes’ encourages the creation of new memories in everlasting style, while reflecting upon the unforgettable moments that make outdoor living cherishable. The complete Outdoor 2024 Collection is now available online at Arhaus.com and in more than 90 Arhaus showrooms nationwide.

Key Points: 
  • The complete Outdoor 2024 Collection is now available online at Arhaus.com and in more than 90 Arhaus showrooms nationwide.
  • We hope this Outdoor Collection inspires your most relaxing days ahead.”
    Fusing stylish living with resilient relaxation, ‘Echoes’ presents an array of outdoor introductions with alluring silhouettes, distinctive detailing, and eco-friendly InsideOut Performance Fabric® upholstery for unmatched inspiration.
  • Arhaus also brings bold prints and handwoven designs to life within this season’s new outdoor seating offerings, including the DALA collection created by the incredible artisans at DEDON, the pioneering outdoor furniture and fiber production company.
  • Additional Arhaus outdoor introductions and expanded collections include:
    Adirondack Outdoor Lounge Chair : A modern take on a classic look, the Adirondack Collection celebrates craftsmanship and the beauty of natural solid teak wood.

Heron Therapeutics Announces Approval of ZYNRELEF® by Health Canada for the Management of Postoperative Pain

Retrieved on: 
Donnerstag, März 17, 2022
Health Canada, Safety, Therapy, Boxed warning, U.S. Securities and Exchange Commission, NSAID, Surgical incision, European Economic Area, Drug discovery, Patient, Heron, News, Bupivacaine, Private Securities Litigation Reform Act, Coronavirus, FDA, Pain, Nasdaq, Meloxicam, Pharming, Forward-looking statement, Analgesic, Head, Dizziness, COVID-19, NOC, Food, DALA, Company, Union, Foot, Incidence, Ankle, SAN, Human, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmaceutical industry, Compliance

SAN DIEGO, March 17, 2022 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that Health Canada has issued a Notice of Compliance (NOC) to commercialize ZYNRELEF (bupivacaine and meloxicam extended-release solution) for instillation into the surgical wound for postoperative analgesia after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty surgical procedures. Based on prior agreements with the U.S. Food and Drug Administration (FDA), Heron already has clinical studies underway, which we plan to submit to Health Canada to expand the indication statement.

Key Points: 
  • It is a dual-actingfixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
  • "With this approval, Heron will move forward with partnering discussions and submitting manufacturing supplements to Health Canada for large-scale suppliers of ZYNRELEF to significantly reduce ZYNRELEF's cost of goods.
  • ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution.
  • ZYNRELEF demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids, with more patients opioid-free compared to bupivacaine solution.

Heron Therapeutics Announces Filing of a Supplemental New Drug Application for Significant Expansion of ZYNRELEF® Indication Statement Based on Successful Outcome of FDA Type C Meeting

Retrieved on: 
Montag, Oktober 4, 2021
Vomiting, Heart failure, European Economic Area, Tears, Food, News, Therapy, Safety, Nonsteroidal anti-inflammatory drug, Gastrointestinal bleeding, NDAS, NDA, Human, Ulcer, Alignment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Allergy, Stroke, Private Securities Litigation Reform Act, DALA, Aspirin, FDA, U.S. Securities and Exchange Commission, Ibuprofen, Investor relations, Patient, Boxed warning, Constipation, Pregnancy, Heron, Media contacts database, Ankle, Coronavirus, Head, Time-invariant system, Anemia, Media, Bupivacaine, Death, Medicine, New Drug Application, Company, European Union, Pain, Naproxen, SAN, Risk, Liver, Type C, Union, Drug discovery, Pharming, Forward-looking statement, Foot, Nasdaq, Meloxicam, Headache, COVID-19, Pharmaceutical industry

This submission is based on the consistent safety, efficacy and pharmacokinetic data from previously completed clinical trials.

Key Points: 
  • This submission is based on the consistent safety, efficacy and pharmacokinetic data from previously completed clinical trials.
  • The studies in these additional surgeries are already in progress with the plan to submit the next supplement in the second half of 2022.
  • "Our Type C meeting with the FDA was very positive, with alignment on next steps for the submission of two sequential supplemental NDAs designed to expand the ZYNRELEF indication statement in a stepwise fashion.
  • "Submission of the first supplement within three months of launching ZYNRELEF is a major accomplishment, with the second supplement planned for next year."