IV

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Retrieved on: 
Monday, July 11, 2022
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CAMBRIDGE, Mass., July 11, 2022 /PRNewswire/ -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.

Key Points: 
  • The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs.
  • "Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients.
  • We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need."
  • "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward."

SIGA Technologies Receives Approval from UK for Tecovirimat

Retrieved on: 
Friday, July 8, 2022
European Medicines Agency, Research, GLOBE, Ix, COVID-19, Smallpox, EMA, Contract, Food, Biomedical Advanced Research and Development Authority, Monkeypox, Human services, BARDA, Vaccine, Patent, Vaccination, Regulation of tobacco by the U.S. Food and Drug Administration, Cowpox, FDA, Government, Exercise, Phrase, Xi, Development, Infection, Risk, Vii, Forward-looking statement, Documentation, CEO, Human, SIGA Technologies, Policy, Private Securities Litigation Reform Act, NASDAQ, Annual report, Assistant, Project Bioshield Act, United States Department of Health and Human Services, Health Canada, United Kingdom, Vaccinia, IV, Pharmaceutical industry

In early 2022 SIGA also received market authorization for tecovirimat from the European Medicines Agency for the treatment of smallpox, monkeypox, cowpox, and complications from vaccinia infection.

Key Points: 
  • In early 2022 SIGA also received market authorization for tecovirimat from the European Medicines Agency for the treatment of smallpox, monkeypox, cowpox, and complications from vaccinia infection.
  • SIGA Technologies, Inc.is a commercial-stage pharmaceutical company focused on the health security market.
  • Oral tecovirimat received approval from theEuropean Medicines Agency(EMA) in 2022.
  • The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.

Iterum Therapeutics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

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Wednesday, July 6, 2022
GLOBE, Penem, Company, Employment, Bacteria, ITRM, Nasdaq, Infection, IV, QIDP, Therapy, Pharmaceutical industry

This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.

Key Points: 
  • This grant wasawarded pursuant to the Nasdaq inducement grant exception as a component of new hire employment compensation.
  • The share option was granted effectiveJuly 5, 2022with an exercise price of$0.22per share, which is equal to the closing price of Iterum Therapeutics ordinary shares on the date of grant.
  • The share option was approved by the Companys Compensation Committee and was granted as an inducement material to the new employees acceptance of employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The share option is subject to the terms and conditions of a share option agreement covering the grant and the Companys 2021 Inducement Equity Incentive Plan.

DiaMedica Therapeutics Announces Clinical Hold of its Phase 2/3 ReMEDy2 Clinical Trial for DM199

Retrieved on: 
Wednesday, July 6, 2022
Health, FDA, Medical Devices, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Review, FDA, TPA, Kidney, Patient, Blood pressure, U.S. Securities and Exchange Commission, File, Rankine scale, KLK1, COVID-19, Population, Urine, Stroke, Nitric oxide, Company, Goal, Oxidative stress, Annual report, Lists of diseases, Terminology, Inflammation, Neurogenesis, Vascular dementia, Hypotension, AIS, Food, Risk, Letter, Clinical trial, Patient safety, Chronic kidney disease, Nasdaq, Fibrosis, Retinopathy, Hypertension, Private Securities Litigation Reform Act, Form 10-K, MRS, DMAC, Phase II, Tissue plasminogen activator, Recurrence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nature, IV, Therapy, Method, Hospital, Pharmaceutical industry

The Company notes that no such hypotension issues were reported in its ReMEDy1 trial in which 46 stroke patients received DM199.

Key Points: 
  • The Company notes that no such hypotension issues were reported in its ReMEDy1 trial in which 46 stroke patients received DM199.
  • Based on information received to date, DiaMedica believes that proportionate reductions in the DM199 dose level and IV infusion times will effectively mitigate the hypotension issue in ReMEDy2 patients.
  • The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Companys product candidate, DM199, to treat AIS patients.
  • DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases.

HCMC ANNOUNCES JEREMY SWAYMAN, THE BOSTON BRUINS AND NHL ALL- ROOKIE TEAM GOALTENDER, TO A MARKETING AND AWARENESS CAMPAIGN FOR ITS FIRST HEALTHY CHOICE WELLNESS CENTER IN BOSTON

Retrieved on: 
Wednesday, July 6, 2022
Seafood, GLOBE, Marketing, Growth, Company, U.S. Securities and Exchange Commission, Social media, Security (finance), Website, Securities Act of 1933, Securities Exchange Act of 1934, Weight loss, Public expenditure, AT, Beauty, LLC, National Food Security Act, 2013, Fatigue, SEC, Vitamin, Income, CEO, Inflammation, Antioxidant, Private Securities Litigation Reform Act, Health, Food science, Meat, Dairy, NHL All-Rookie Team, Awareness, NHL, Grand, Immunity, IV, OTC Markets Group, Dietary supplement, Holding company, Grocery store, HCMC

HOLLYWOOD, FL, July 06, 2022 (GLOBE NEWSWIRE) -- Healthier Choices Management Corp. (OTC Pink: HCMC) In its effort to launch a significant awareness campaign and bring its healthy based IV services to the local Boston community, Healthy Choice Wellness Center has enlisted goalie Jeremy Swayman to assist in the marketing and awareness campaign that will include social media and personal appearances.

Key Points: 
  • After a stellar season, which included being the goalie for all three Bruins playoff wins, Jeremy was recently named to the 2021-22 NHL All Rookie Team.
  • Healthy Choice Wellness Center clients will have the opportunity to meet their hometown hero Jeremy Swayman at the Boston Direct Health location in exclusive client meet and greet events.
  • Jeff Holman, CEO of HCMC, had this to say, We are extremely excited to be working with both Jeremy and Dr. Zivich within his Boston Direct Health Center.
  • Mr. Holman continued, We are equally excited to be opening our first Healthy Choice Wellness Center within a medical facility.

Restore Hyper Wellness to Open 28 New Locations in Southern California

Retrieved on: 
Wednesday, July 6, 2022
Women, Fitness & Nutrition, Men, Specialty, Family, Alternative Medicine, Health, Consumer, Retail, General Atlantic, Orangetheory Fitness, Love, AJ Capital Partners, Cryotherapy, Growth, IM, CorePower Yoga, European Wax Center, IV, Multimedia, Video game, Restaurant, Restore, New Circadia

Restore Hyper Wellness (Restore), a leading provider of proactive wellness services, announced its rapid expansion into Southern California.

Key Points: 
  • Restore Hyper Wellness (Restore), a leading provider of proactive wellness services, announced its rapid expansion into Southern California.
  • View the full release here: https://www.businesswire.com/news/home/20220706005297/en/
    Restore Hyper Wellness to open 28 new locations in Southern California through exempt franchise transactions.
  • (Photo: Business Wire)
    Pete Selner and Marc Thomas, who operate over 40 Orangetheory Fitness locations, have committed to opening 40 Restore locations over several years.
  • Launched in Austin, Texas in 2015, Restore Hyper Wellness (Restore) is the award-winning creator of an innovative new category of careHyper Wellness.

SURFORMA GLOBALLY LAUNCHES BALLISTIC PLATE

Retrieved on: 
Wednesday, July 6, 2022
Furniture, III, Research, Telecommunication, Industry, NIJ, Partnership, Sonae, Technology, United Nations Global Compact, Leadership, IV, Renewable energy

PORTO, Portugal, July 6, 2022 /PRNewswire/ -- Surforma has launched on the world market CompactShield, a ballistic plate for use in urban environments with civil risks, aimed at more demanding markets for the protection of people, especially in countries in regional blocks such as America, Africa, and the Middle East.

Key Points: 
  • PORTO, Portugal, July 6, 2022 /PRNewswire/ -- Surforma has launched on the world market CompactShield, a ballistic plate for use in urban environments with civil risks, aimed at more demanding markets for the protection of people, especially in countries in regional blocks such as America, Africa, and the Middle East.
  • With level IIIA, III, and IV protection, according to the NIJ standard 0108:01, the new ballistic CompactShield is mainly intended for the sectors of construction (public buildings, police stations, banks, etc.)
  • The company has, this way, started a process of globally repositioning its Laminates and Compacts business, both structurally, with the introduction of new raw materials, and technically, by investing in new ranges with improved performance.
  • The company operates in over 30 countries, in 5 continents.

SURFORMA GLOBALLY LAUNCHES BALLISTIC PLATE

Retrieved on: 
Wednesday, July 6, 2022
Furniture, III, Research, Telecommunication, Industry, NIJ, Partnership, Sonae, Technology, United Nations Global Compact, Leadership, IV, Renewable energy

PORTO, Portugal, July 6, 2022 /PRNewswire/ -- Surforma has launched on the world market CompactShield, a ballistic plate for use in urban environments with civil risks, aimed at more demanding markets for the protection of people, especially in countries in regional blocks such as America, Africa, and the Middle East.

Key Points: 
  • PORTO, Portugal, July 6, 2022 /PRNewswire/ -- Surforma has launched on the world market CompactShield, a ballistic plate for use in urban environments with civil risks, aimed at more demanding markets for the protection of people, especially in countries in regional blocks such as America, Africa, and the Middle East.
  • With level IIIA, III, and IV protection, according to the NIJ standard 0108:01, the new ballistic CompactShield is mainly intended for the sectors of construction (public buildings, police stations, banks, etc.)
  • The company has, this way, started a process of globally repositioning its Laminates and Compacts business, both structurally, with the introduction of new raw materials, and technically, by investing in new ranges with improved performance.
  • The company operates in over 30 countries, in 5 continents.

Independence Contract Drilling Adds Robert Barrett to its Board of Directors

Retrieved on: 
Friday, July 1, 2022
Angelo Gordon, The Company, Board of directors, Georgetown University, Credit Suisse, ICD, University, Company, Committee, Energy, Corporate governance, Corporate development, University of Virginia Darden School of Business, NYSE, Audit committee, Goldman Sachs, Board, UBS, IV, Director, Management

HOUSTON, July 1, 2022 /PRNewswire/ -- Independence Contract Drilling, Inc. (the "Company" or "ICD") (NYSE: ICD) today announced that its Board of Directors elected Robert J. Barrett, IV to its Board of Directors.

Key Points: 
  • HOUSTON, July 1, 2022 /PRNewswire/ -- Independence Contract Drilling, Inc. (the "Company" or "ICD") (NYSE: ICD) today announced that its Board of Directors elected Robert J. Barrett, IV to its Board of Directors.
  • Mr. Barrett will serve on the Company's Audit Committee and will chair the Company's Corporate Governance and Nominating Committee.
  • Anthony Gallegos, President and Chief Executive Officer commented, "On behalf of the Board of Directors, I'm very pleased to welcome Bobby to ICD.
  • Independence Contract Drilling provides land-based contract drilling services for oil and natural gas producers in the United States.

US FDA seeks more information on Maxigesic IV® application

Retrieved on: 
Friday, July 1, 2022
FDA, CRL, Patient, LinkedIn, Endpoint security, Company, Industry, Issuer, Food, HYL, Atrial fibrillation, Medicine, US Foods, Safety, IV, NDA, Euronext, AFT, Pharmaceutical industry, Risk management

Lige, Belgium 01 July 2022 - Regulted information - Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels : HYL) announces that it has today received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its application for the US registration of Maxigesic IV.

Key Points: 
  • Lige, Belgium 01 July 2022 - Regulted information - Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels : HYL) announces that it has today received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its application for the US registration of Maxigesic IV.
  • We believe, along with our partners at AFT, that generating the additional information that FDA requires to support the NDA submission of Maxigesic IV will allow the product to fulfill its full commercial potential in the US and not affect the Companys other existing development programs.
  • Maxigesic IV, is a novel, unique combination of 1000mg paracetamol and 300mg ibuprofen solution for infusion, for the treatment of post-operative pain and is currently licensed in more than 100 countries across the globe.
  • Two products are currently in initial phases of commercialisation with partners: Sotalol IV for the treatment of atrial fibrillation, and Maxigesic IV, a non-opioid post-operative pain treatment.