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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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Aleut Achieves Prestigious CMMI Level 3 Certification in Four Key Domains

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January 9, 2025

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RESTON, Va., Jan. 9, 2025 /PRNewswire/ — Aleut Federal LLC (Aleut) proudly announces it has earned Capability Maturity Model Integration (CMMI) Level 3 certification in four key domains: Development (CMMI-DEV), Services (CMMI-SVS), Security (CMMI-SEC), and People Management (CMMI-PPL). This significant achievement highlights Aleut’s commitment to operational excellence and its ability to deliver high-quality, efficient and secure solutions. It demonstrates Aleut’s strength in optimizing product development, improving service delivery, enhancing security, and aligning workforce management to drive performance and engagement. 

CMMI, developed by the globally recognized CMMI Institute, is a framework for assessing and improving organizational performance. Achieving Level 3 certification affirms that Aleut’s processes are clearly defined, consistently applied, and supported by robust standards, tools, and methodologies. This milestone underscores the company’s ongoing dedication to operational excellence, mitigating risk, and delivering measurable performance success.

“This certification shows our customers that Aleut doesn’t just meet their mission-critical needs – we excel at it,” said Nick Trzcinski, President of Aleut Federal. “We are committed to continuous improvement, innovation, and delivering exceptional value. Aleut is a partner our customers can trust.”

Aleut’s CMMI Level 3 certification enhances its ability to deliver high-quality outcomes across all projects while optimizing efficiency and minimizing risks. Complemented by the company’s ISO 9001 certification for quality management, these achievements reinforcing Aleut’s adherence to internationally recognized standards, solidifying its position as a reliable and innovative partner for federal clients.

To read Aleut Federal’s CMMI Appraisal, click here.

ABOUT ALEUT FEDERAL
Aleut Federal LLC, a holding company within The Aleut Corporation’s federal services portfolio, is an Alaska Native-owned enterprise delivering vital services to the U.S. government across four primary sectors: Technology, Mission Support, Environmental, and Construction. Established under the Alaska Native Claims Settlement Act (ANCSA) of 1971, The Aleut Corporation is one of 12 regional Alaska Native corporations. Aleut Federal’s subsidiaries, including Small Business Administration (SBA) certified 8(a) program participants and Small Disadvantaged Business (SDB) entities, bring specialized capabilities to meet the diverse needs of federal agencies.

By achieving CMMI Level 3 certification, Aleut Federal strengthens its standing as an industry leader, driving performance excellence while delivering mission-focused solutions with unmatched quality and efficiency.

Contact:
Berlyn Martin
Aleut Federal, LLC
Phone: 276-244-3319

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SOURCE Aleut Federal, LLC

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Lowell Observatory Scientists to Present New Research at American Astronomical Society Winter Meeting- Including New and Unexpected Insights on Planet Formation

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January 9, 2025

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Lowell Observatory researchers will join more than 3,000 astronomers at AAS245 in Maryland from January 12-16, 2025

FLAGSTAFF, Ariz., Jan. 9, 2025 /PRNewswire/ — The American Astronomical Society’s winter meeting is the largest annual gathering of astronomers in the United States, and Lowell Observatory will be well-represented this year. Executive Director Dr. Amanda Bosh and Director of Science Dr. Gerard van Belle—both of whom just stepped into their positions—lead a contingency of more than a dozen scientists and support staff attending the meeting.

Lowell Observatory will be in attendance at Exhibitor Booth 521, with its astronomers, postdocs, predocs, and other researchers available to discuss their latest science research. Of particular note, Postdoctoral Fellow Taylor Kutra will share unexpected new ways planets may form, based on a study of a binary star system in Taurus that she leads. Kutra will present her findings during both a Tuesday (January 14) science session and Thursday (January 16) press conference.

Other Lowell Observatory scientists will present on topics including comets, asteroids, the Sun and Sun-like stars, exoplanets, a variety of star types, dwarf irregular galaxies, and space-based interferometry.

Bosh says, “The winter meeting of the AAS is a critical opportunity for astronomers at all stages of their careers to share their latest research and interact with colleagues from around the world. Lowell Observatory is pleased to send a strong contingency of our science team to actively participate in this year’s meeting in National Harbor.”

Media are welcome to attend AAS245 in person. A limited virtual attendance option is also available, with live access to press conferences, plenary talks, select town halls, and a virtual oral session. See https://aas.org/meetings/aas245/press.

AAS245 website: https://aas.org/meetings/aas245

AAS245 Presentations by Lowell Observatory Scientists: Full Schedule Here

About Lowell Observatory
Founded in 1894, Lowell Observatory in Flagstaff, Arizona, is a renowned nonprofit research institution. It is the site of historic and groundbreaking discoveries, including the first evidence of the expanding universe and the discovery of Pluto. Today, Lowell’s astronomers utilize global ground-based and space telescopes, along with NASA spacecraft, for diverse astronomical and planetary science research. The observatory hosts over 100,000 annual visitors for educational tours, presentations, and telescope viewing through a suite of world-class public telescopes.

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SOURCE Lowell Observatory

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CRTC consults on market dynamics within Canada’s broadcasting system

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January 9, 2025

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OTTAWA, ON and GATINEAU, QC, Jan. 9, 2025 /CNW/ – Today, the CRTC is taking another step forward to implement the modernized Broadcasting Act (the Act) by launching a public consultation on market dynamics within Canada’s broadcasting system.

Through this consultation, the CRTC will explore the dynamics between small, medium and large broadcasters, television service providers and online streaming services. The goal is to help ensure that Canada’s broadcasting system is sustainable, fair and competitive.

The CRTC is welcoming comments until February 24, 2025. Interested persons can participate by:

filling out the online form;writing to the Secretary General, CRTC, Ottawa, Ontario K1A 0N2;sending a fax to 819-994-0218.

As part of this consultation, the CRTC will hold a public hearing starting on May 12, 2025.

All comments will form part of the public record and will inform the CRTC’s decision.

The launch of today’s consultation follows a number of recent actions the CRTC has taken to implement the modernized Act. To find out more, check out the CRTC’s regulatory plan.

Quick facts

The CRTC is an independent quasi-judicial tribunal that regulates the Canadian communications sector in the public interest. The CRTC holds public consultations on telecommunications and broadcasting matters and makes decisions based on the public record.First Nations, Inuit, and Métis peoples and Indigenous organizations requiring assistance submitting comments, including oral interventions, can contact the CRTC’s Indigenous Relations Team.

Associated links

Participate in the consultationRegulatory PlanModernizing Canada’s broadcasting framework

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SOURCE Canadian Radio-television and Telecommunications Commission

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