Heated tobacco product

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

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금요일, 2월 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.

Mindgruve and Kick It California Tackle Public Health Epidemic with Gamified App

Retrieved on: 
목요일, 2월 15, 2024

SAN DIEGO, Feb. 15, 2024 /PRNewswire/ -- Mindgruve, one of the premiere digital marketing agencies in the U.S., is excited to announce its partnership with Kick It California, the longest-running statewide phone-based tobacco cessation program in the U.S. The collaboration focuses on a complete redesign of the app formerly known as NoButts and NoVape, now rebranded as the Kick It app, tailored to aid users in their journey to quit both smoking and vaping. The app officially launched on December 29, 2023.

Key Points: 
  • The collaboration focuses on a complete redesign of the app formerly known as NoButts and NoVape, now rebranded as the Kick It app, tailored to aid users in their journey to quit both smoking and vaping.
  • The app officially launched on December 29, 2023.
  • "We're confident that this new app will be a powerful behavioral modification tool for Californians."
  • Powered by UC San Diego and funded by the CA Department of Public Health and First 5 CA, Kick It California has been helping Californians quit smoking, vaping, and smokeless tobacco for over 30 years.

Kaival Brands Provides Business Update in Letter to Shareholders

Retrieved on: 
수요일, 2월 14, 2024

Operating Expenses decreased to $13.2 million compared to $15.6 million, with the decrease driven primarily by disciplined cost management.

Key Points: 
  • Operating Expenses decreased to $13.2 million compared to $15.6 million, with the decrease driven primarily by disciplined cost management.
  • As of October 31, 2023, Kaival Brands had working capital of approximately $1.9 million and total cash of approximately $0.5 million.
  • Through it all, we remain committed to steadfast compliance with established FDA requirements for our products and business as we have since our inception.
  • Those ten products remain available for sale through Kaival Brands, subject to FDA’s enforcement discretion.

FDA Approves First Medication to Treat Severe Frostbite

Retrieved on: 
수요일, 2월 14, 2024

SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Key Points: 
  • SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
  • Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.
  • Iloprost's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial that randomized 47 adults with severe frostbite, who all received aspirin by vein and standard of care, into one of three treatment groups.
  • The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).

Pyxus International, Inc. Reports Strong Third Quarter and Year-to-Date Fiscal 2024 Results

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수요일, 2월 14, 2024

MORRISVILLE, N.C., Feb. 14, 2024 /PRNewswire/ -- Pyxus International, Inc. (OTC Pink: PYYX) ("Pyxus," the "Company," "we," or "our,"), a global value-added agricultural company, today announced results for its fiscal quarter ended December 31, 2023.

Key Points: 
  • MORRISVILLE, N.C., Feb. 14, 2024 /PRNewswire/ -- Pyxus International, Inc. (OTC Pink: PYYX) ("Pyxus," the "Company," "we," or "our,"), a global value-added agricultural company, today announced results for its fiscal quarter ended December 31, 2023.
  • This success positions us to increase our full-year guidance as we remain focused on concluding an outstanding fiscal year."
  • Gross margin through the first nine months of fiscal 2024 improved to 15.6% from 13.0% compared to fiscal 2023, and was driven by a more favorable customer and regional mix.
  • Pyxus achieved a third quarter gross margin of 17.5% compared to 13.4% in the third quarter of fiscal 2023.

NEW DATA: 70% OF AMERICANS UNAWARE OF COMMON VASCULAR DISEASE THAT IS ONE OF THE LEADING CAUSES OF AMPUTATION

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목요일, 2월 8, 2024

WASHINGTON, Feb. 8, 2024 /PRNewswire/ -- According to a new national survey released today by the PAD Pulse Alliance, 70% of Americans are unaware of peripheral artery disease (PAD) – the most common vascular disease in which leg arteries become narrowed, reducing or cutting off blood flow, contributing to 400 amputations performed each day in the United States. The top risk factors for PAD are common chronic health conditions that disproportionately impact underserved communities. Yet among Black and Hispanic adults, nearly 80% report never having a doctor or healthcare provider discuss PAD with them – underscoring the need to start the conversation.

Key Points: 
  • The top risk factors for PAD are common chronic health conditions that disproportionately impact underserved communities.
  • That's why we're encouraging anyone with leading risk factors, diabetes, high blood pressure and use of tobacco products, to know your 'three for PAD' and talk to your doctor."
  • Data from the PAD Pulse Alliance survey highlights a disconnect among people between the risk factors and their personal perceived risk of PAD.
  • Nearly eight in 10 Black and Hispanic never had a doctor or healthcare provider talk with them about PAD.

JT Group Recognized on CDP’s Climate Change A List and Water Security A List

Retrieved on: 
수요일, 2월 7, 2024

The JT Group is one of 61 companies worldwide and 22 in Japan to be included on the Climate Change A List and Water Security A List, out of more than 23,000 companies participating in the 2023 CDP environmental disclosure program.

Key Points: 
  • The JT Group is one of 61 companies worldwide and 22 in Japan to be included on the Climate Change A List and Water Security A List, out of more than 23,000 companies participating in the 2023 CDP environmental disclosure program.
  • Overall, this inclusion marks the Group's sixth recognition for climate change, and fourth recognition for water security.
  • Hisato Imokawa, Senior Vice President, Chief Sustainability Officer, said: "We are honored that the JT Group has been recognized on CDP’s A List for a fifth consecutive year.
  • 3 The JT Group Purpose “Fulfilling Moments, Enriching Life” is designed to clarify the direction to being a sustainable entity.

Murray R. Garnick, Executive Vice President & General Counsel, Announces Decision to Retire

Retrieved on: 
목요일, 2월 1, 2024

(NYSE: MO) Murray R. Garnick, Executive Vice President & General Counsel of Altria Group, Inc. (Altria), has notified the company of his decision to retire effective April 1, 2024.

Key Points: 
  • (NYSE: MO) Murray R. Garnick, Executive Vice President & General Counsel of Altria Group, Inc. (Altria), has notified the company of his decision to retire effective April 1, 2024.
  • “In addition to Murray’s significant individual contributions, his passion for developing world-class legal and regulatory talent has contributed tremendously to Altria’s success.
  • I am grateful for his many contributions, and I wish him the best in retirement.”
    Robert (Bob) A. McCarter will become Altria’s Executive Vice President & General Counsel effective April 1, 2024.
  • Currently Bob serves as Senior Vice President & Associate General Counsel, ALCS, where he supervises the management of tobacco, health and other litigation.

Manufacturing PMI® at 49.1%; January 2024 Manufacturing ISM® Report On Business®

Retrieved on: 
목요일, 2월 1, 2024

TEMPE, Ariz., Feb. 1, 2024 /PRNewswire/ -- Economic activity in the manufacturing sector contracted in January for the 15th consecutive month following one month of "unchanged" status (a PMI® reading of 50 percent) and 28 months of growth prior to that, say the nation's supply executives in the latest Manufacturing ISM® Report On Business®.

Key Points: 
  • (A Manufacturing PMI® above 42.5 percent, over a period of time, generally indicates an expansion of the overall economy.)
  • The Prices Index registered 52.9 percent, up 7.7 percentage points compared to the reading of 45.2 percent in December.
  • The Backlog of Orders Index registered 44.7 percent, 0.6 percentage point lower than the 45.3 percent recorded in December.
  • "The Supplier Deliveries Index figure of 49.1 percent is 2.1 percentage points higher than the 47 percent recorded in December.

Kaival Brands Partner Bidi Vapor to Contest FDA Denial of ‘Classic’ Tobacco-Flavored ENDS

Retrieved on: 
월요일, 1월 29, 2024

GRANT-VALKARIA, Fla., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Kaival Brands Innovations Group, Inc. (NASDAQ: KAVL) ("Kaival Brands," the "Company" or "we,” “our” or similar terms), a company focused on incubating and commercializing innovative products into mature and dominant brands, with a current focus on the distribution of electronic nicotine delivery systems (ENDS), which are intended for adults 21 and over, today announced that its licensor and commercial partner, Bidi Vapor LLC (Bidi Vapor), will appeal the U.S. Food and Drug Administration’s (FDA) decision to deny Bidi Vapor’s premarket tobacco product application (PMTA) for Bidi Vapor’s “Classic” tobacco-flavored BIDI® Stick ENDS device. Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor.

Key Points: 
  • Kaival Brands holds the worldwide license to distribute products made by Bidi Vapor.
  • On Monday, January 22, 2024, the FDA issued a marketing denial order (MDO) for Bidi Vapor’s “Classic” BIDI® Stick PMTA.
  • “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the Founder & Chief Executive Officer of Bidi Vapor, who is also the Chief Science Officer & Founder of Kaival Brands.
  • “While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser focused on selling the Bidi Vapor products that we are permitted to,” said Barry M. Hopkins, Executive Chairman of Kaival Brands.