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Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration

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NANJING, China, Sept. 5, 2024 /PRNewswire/ — On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). Sanbexin sublingual tablets is the first innovative drug in the world to be designated with the Breakthrough Therapy by the FDA for the treatment of stroke.

The Breakthrough Therapy designation stems from the provisions of the “Food and Drug Administration Safety and Innovation Act”. It is designed to expedite the development and regulatory review of drugs for treating serious diseases and addressing significant unmet medical needs. The designation will be beneficial for the drugs to obtain the FDA’s guidance in the clinical development, accelerate the overseas clinical development process, and is also expected to significantly shorten the time for marketing review through the priority review designation.

The Breakthrough Therapy designation is based on the significant improvement in efficacy metrics demonstrated by the sublingual tablets in a previous clinical study. The data from a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study in China for the treatment of AIS demonstrated that Sanbexin sublingual tablets significantly improved neurological recovery and independent living ability in patients with AIS compared to placebo, meeting the expected efficacy endpoints with a favorable safety profile. JAMA Neurology published the study’s key findings online.

The designation will be beneficial for Simcere to obtain the FDA’s guidance in the clinical development of Sanbexin sublingual tablets, accelerate the overseas clinical development process, and is also expected to significantly shorten the time for marketing review through the priority review designation.

According to a recent article in The Lancet, stroke is the second leading cause of death and disability worldwide, with 12 million new cases and 6.6 million deaths each year. Among them, acute ischemic stroke is the most common type of stroke, accounting for about 70% of all strokes, and constituting a heavy disease burden for all countries around the world. The efficacy of acute ischemic stroke treatment is highly time-dependent. Receiving treatment as early as possible will help patients to improve their disease outcome and avoid disability.

Sanbexin sublingual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual formulation can quickly disintegrate once in contact with the saliva once place under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sequential therapy consisting of the marketed Sanbexin concentrated solution for Injection. These two formulae enable patients to receive a complete course of treatment in and outside of the hospital.

On June 28, 2023, the new drug application (NDA) for Sanbexin sublingual tablets in China is accepted by the National Medical Products Administration. The first indication is for the improvement of neurological symptoms, daily activities, and functional impairment due to AIS. Phase I clinical trials for Sanbexin sublingual tablets on healthy volunteers have been completed in the United States.

 

View original content:https://www.prnewswire.co.uk/news-releases/breakthrough-therapy-designation-for-sanbexin-sublingual-tablets-granted-by-the-united-states-food-and-drug-administration-302239018.html

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Dana-Farber Cancer Institute Partners with Clinical.ly to Enhance Regulatory Operations with eReg Solutions

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September 19, 2024

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NEW YORK, Sept. 19, 2024 /PRNewswire/ — The Dana-Farber Cancer Institute, a world leader in cancer treatment and research, chose Clinical.ly’s (www.clinical.ly) Research Suite™ to streamline regulatory operations, marking a significant step toward more efficient and compliant clinical trial management. Dana-Farber joins a growing number of research organizations that leverage Clinical.ly’s innovative solutions to streamline clinical trial processes. Clinical.ly’s eReg platform offers a comprehensive, paperless solution that centralizes regulatory workflows, ensuring compliance and transparency across clinical trials.

“We are thrilled to support Dana-Farber’s clinical research operations,” said Henry Kravchenko, Clinical.ly’s CEO.

This partnership continues Clinical.ly’s success in providing best-in-class enterprise tools for conducting clinical research. “We are thrilled to support Dana-Farber’s clinical research operations,” said Henry Kravchenko, Clinical.ly’s CEO. “Our eReg platform and wider set of features in Clinical.ly Research Suite™ will empower that renowned organization, and we all look forward to supporting their teams.”

About Clinical.ly Research Suite™ 

Clinical.ly Research Suite™ is a comprehensive solution that eliminates traditional, paper-based processes. By automating and centralizing essential workflows in the Clinical.ly Research Suite™, organizations achieve huge efficiency improvements, greater trial oversight, document management, and regulatory compliance. The Clinical.ly Research Suite™ includes:

eReg: A best-in-class electronic regulatory bindereSource: An intuitive & feature-rich, paperless data capture solution that streamlines data collection from trial participantseConsent: A fully digital solution for capturing informed consent, improving participant engagement and site complianceClinicallySign: 21 CFR Part 11 compliant eSignature functionalityClinicallyPay: A secure and instantaneous participant stipend payment and reimbursement solution

About Dana-Farber Cancer Institute

Founded in 1947, Dana-Farber Cancer Institute is committed to providing adults and children with the best treatment available today while developing tomorrow’s cures through cutting-edge research. Based in Boston, Dana-Farber is a teaching affiliate of Harvard Medical School and ranks consistently as one of the top cancer hospitals in the world.

About Clinical.ly

Clinical.ly provides differentiated, cloud-native technology solutions to the clinical research industry, enabling research organizations to conduct studies with greater efficiency and ease. Clinical.ly is dedicated to developing technology that eliminates tedious manual labor, allowing clinical research professionals to focus on patient care.

View original content to download multimedia:https://www.prnewswire.com/news-releases/dana-farber-cancer-institute-partners-with-clinically-to-enhance-regulatory-operations-with-ereg-solutions-302253690.html

SOURCE Clinical.ly

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Fall Into Creativity with the Monport Laser Fall Sale

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September 19, 2024

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NEW YORK, Sept. 19, 2024 /PRNewswire/ — Experience laser innovation this Fall with Monport Laser, an industry frontrunner in laser engraving and cutting technology, with an exclusive Fall Sale offering incredible discounts and free accessories on a wide range of high-performance laser engraving machines. From September 19th to September 30th, customers can take advantage of this limited-time opportunity to elevate their laser engraving businesses with cutting-edge laser innovation at unbeatable prices.

Monport Laser has been dedicated to providing innovative and reliable laser machines that empower businesses and individuals to achieve their goals. With a focus on quality, precision, and customer satisfaction, Monport Laser has established itself as a trusted leader in the industry. Their commitment to excellence is evident in every laser they produce, ensuring exceptional performance, reliability, and value.

Embrace the Power of CO2 Laser Technology with Exclusive Offers

Monport Laser will offer two free accessories with selected CO2 laser machines during the Monport Fall sale. These versatile lasers are ideal for various applications, including engraving, cutting, and marking wood, acrylic, leather, and more. By taking advantage of this Fall sale, laser engraving businesses can enhance their productivity and expand their creative possibilities.

Experience Unmatched Value with Fiber Laser Discounts

Monport Laser offers substantial discounts of up to $4200 and 3 free accessories on selected models for those seeking the precision and speed of fiber laser technology. Fiber lasers are renowned for their ability to process metals with exceptional efficiency and accuracy, making them indispensable for metal fabrication, manufacturing, and jewelry production. Additionally, customers purchasing fiber lasers during the Fall sale will receive three free accessories, further sweetening the deal.

Elevate Your Desktop Laser Experience with a Free Water Chiller

Monport Laser is committed to providing comprehensive solutions for businesses of all sizes. As part of the Fall sale, customers who purchase the 40W Desktop laser will receive a Free Water Chiller Cw3000. This essential accessory ensures optimal cooling and performance, prolonging the lifespan of the laser and guaranteeing consistent results.

Discover Additional Savings on a Wide Range of Accessories

Monport Laser offers an additional 20% discount on selected accessories to complete your laser setup. From lenses and nozzles to rotary tables and smoke extraction systems, customers can find everything they need to maximize the potential of their laser machines.

Unleash Your Creativity and Productivity

Monport Laser’s Fall sale is the perfect opportunity to invest in laser technology that empowers your business or fuels your creative passions. With exceptional discounts and free accessories, you can acquire the ideal laser solution to meet your needs and budget.

Whether you’re an entrepreneur, artist, or manufacturer, Monport Laser’s advanced laser machines offer unparalleled precision, versatility, and reliability. Take advantage of this limited-time Fall sale and unlock your projects’ full potential for laser innovation.

About Monport Laser

Monport Laser is a global leader in designing, manufacturing, and distributing high-quality laser machines and accessories. With a commitment to innovation and customer satisfaction, Monport Laser provides cutting-edge solutions for various industries, including manufacturing, engraving, marking, and more.

For more information, visit monportlaser.com and follow them on social media for the latest updates.

Website: https://www.monportlaser.com/

 

 

 

View original content:https://www.prnewswire.com/news-releases/fall-into-creativity-with-the-monport-laser-fall-sale-302253699.html

SOURCE Monport Laser

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MEDIA ADVISORY – Minister Wilkinson to Make a Critical Minerals Infrastructure Announcement

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September 19, 2024

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VANCOUVER, BC, Sept. 19, 2024 /CNW/ – The Honourable Jonathan Wilkinson, Minister of Energy and Natural Resources, and Ranj Pillai, the Premier of Yukon, will make a funding announcement in support of critical minerals infrastructure projects. A media availability will follow.

Date: September 20, 2024

Time: 10:30 a.m. PT

All accredited media are asked to pre-register by emailing media@nrcan-rncan.gc.ca. A dial-in line is available for media and will be provided upon registration.

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SOURCE Natural Resources Canada

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