Amarin Corporation plc (NASDAQ: AMRN) is a pharmaceutical company focused on improving cardiovascular health.
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In the United States CVD leads to one in every three deaths – one death approximately every 38 seconds – with annual treatment cost in excess of $500 billion.
Vascepa (icosapent ethyl) is Amarin’s first FDA-approved drug and is available by prescription in the United States, Lebanon and the United Arab Emirates.
An independent organization that evaluates pricing of prescription drugs has just issued its final report assessing the cost-effectiveness of Vascepa® capsules. The final assessment confirms the cost-effectiveness of Vascepa across all the non-profit organization’s analyses, including its most stringent criteria.
Vascepa is currently approved in the United States as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for a label expansion based on the REDUCE-IT study results showing reduction of cardiovascular events in high-risk patients.
Amarin has submitted a supplemental new drug application (sNDA) to the U.S. FDA for a label expansion based on the REDUCE-IT study results showing reduction of cardiovascular events in high-risk patients. The Prescription Drug User Fee Act (PDUFA) target action date set by the FDA to act on the sNDA is December 28, 2019. Assuming FDA approval, Vascepa is positioned to become the first drug indicated to reduce persistent residual cardiovascular risk in statin-managed patients with elevated triglycerides (135 mg/dL or greater) and other risk factors for cardiovascular disease.
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Northwest Biotherapeutics, Inc. (OTCQB: NWBO) is a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers.
The Company has been investigated by the SEC and has cooperated with the investigation. The Company has now successfully entered into a settlement agreement with the SEC under Rule 13a-15. Under the settlement, in which the Company neither admits nor denies any violations, the Company will pay a fine of $250,000 in connection with past weaknesses in its internal controls.
The Company stated it is pleased to put this matter behind it and concentrate its focus on progressing its clinical programs, including its Phase III trial of DCVax®-L for brain cancer.
The Company has broad platform technologies for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is also pursuing a Phase I/II trial with DCVax®-Direct for all types of inoperable solid tumor cancers. It has completed the 40-patient Phase I portion of the trial, and is preparing for Phase II portions. The Company previously conducted a Phase I/II trial with DCVax®-L for metastatic ovarian cancer together with the University of Pennsylvania.
The company and its primary subsidiary, Canada’s original board game bar and cafe, Snakes & Lattes, and Guelph’s downtown board game cafe, The Boardroom, jointly announced today that they have reached an arrangement to transition The Boardroom’s operations to Snakes & Lattes over the next few months. Concluding a successful three-year run, The Boardroom completed its downtown Guelph journey on Thursday, August 29th, 2019 and closed its doors until November 2019, allowing Snakes & Lattes time to revitalize and retool the cafe space for their grand opening celebration.
Earlier this year, the GRO3 subsidiary received two purchase orders for its ozone-based antimicrobial technologies from Vessl Inc., the owners of Kalvara, for use in their cannabis-infused beverage production facilities. GRO3 will be supplying EcoPrO3-10SS Ozone Side Stream Systems, which will be integrated into the facilities for the purposes of providing an all-natural sanitization and anti-microbial solution throughout the production process. The EcoPrO3-10SS exclusively utilizes aqueous functionality compared to the EcoPrO3 GRO3 60 system which utilizes an aqueous and gaseous combination. The EcoPrO3-10SS for Kalvara will process all liquids in the formulations prior to their products being prepared and packaged for the end-user.
Darkstar Ventures Inc. (OTCQB: DAVC) was verified as an OTCQB company on October 9, 2019.
In June, Darkstar announced a merger with Samsara Luggage, Inc. Samsara is a leading travel and lifestyle brand that supplies innovative smart luggage to the global marketplace. Samsara builds brand value for its customers by combining cutting edge technology with unmatched quality and innovative design. Samsara Luggage is committed to providing products that are up to date with the latest technological advances for its tech-savvy customer base.
Samsara’s smart carry-on suitcase was recently named by Forbes as Best Smart Luggage of 2019, calling it the “it” bag when it comes to smart luggage. Built with aviation-grade aluminum, Samsara’s smart luggage is not only durable and fireproof, but also 20% lighter than any other aluminum case on the market today.
Samsara has just unvieled another round of marketing material with its newest online video with brand founders Kathy Ireland and Tommy Meharey. The launch of the video campaign follows the recent announcement that MI VI, a men’s lifestyle brand by kiWW®, founded by Kathy Ireland and Tommy Meharey, and Samsara smart luggage have joined together to create a line of smart luggage that merges luxury and tech-savvy for today’s millennial traveler.
MI VI | “Meharey Ireland Six”, [pronounced My Six] is a men’s lifestyle brand that is designed to serve the needs of both men and women. MI VI is developed and inspired by Kathy Ireland and Tommy Meharey, a Marine, Millennial and Father, in addition to their other brands, including I’M1. The initial successful product offering is MI VI by Samsara smart luggage, which made its debut at the 2019 MTV Video Music Awards.
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