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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.

 

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AIE Graduates create visual effects for Academy-nominated film

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September 20, 2024

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NAWI, a feature film whose visual effects were created by graduates from the Academy of Interactive Entertainment (AIE), has been officially nominated by Kenya for entry into the 97th Academy Awards in the category of Best International Feature Film. NAWI is a heartfelt story about a young girl’s journey towards empowerment and aims to shed light on a pressing issue that affects countless young women in the Turkana region of Kenya.

CANBERRA, Australia, Sept. 19, 2024 /PRNewswire-PRWeb/ — NAWI, a feature film whose visual effects were created by graduates from the Academy of Interactive Entertainment (AIE), has been officially nominated by Kenya for entry into the 97th Academy Awards in the category of Best International Feature Film. NAWI is a heartfelt story about a young girl’s journey towards empowerment and aims to shed light on a pressing issue that affects countless young women in the Turkana region of Kenya.

“The film has a very important social message to tell so it was rewarding in many ways to be able to contribute to this project. NAWI was a fantastic opportunity for our graduates to put their skills to the test on a full-length feature film,” said Tom Pugh.

AIE graduates and teachers were given the opportunity to work on the film’s visual effects through AIE’s ongoing partnership with Learning Lions, who produced the film with Film Crew & Baobab Pictures. AIE is proud to support Learning Lions non-profit mission to enable young adults in marginalised rural communities of East Africa to become digital creatives by providing game development training and technology.

The visual effects for NAWI were brought to life by AIE teachers and experienced industry professionals, Thomas Magill and Tom Pugh, who were tasked with supervising the visual effects and liaising with the film’s Directors, Apuu Mourine, Kevin Schmutzler, Tobias Schmutzler and Toby Schmutzler. They assembled a team of recent AIE graduates and worked out how to create the effects required to immerse audiences in Nawi’s world.

“Graduates were able to take the skills they had learnt in class and apply them to cinema-quality footage. There was even a bit of nervous excitement working with professional expectations and deadlines,” said Tom Pugh.

Thomas Magill explained that most of the work involved compositing such as fixing blemishes, removing unwanted folds in clothing, changing pages in a book and removing background actors that were in the wrong place.

“We had a river shot where there was only a sandbank, and we had to create an entire island! There were several shots filmed in a dry riverbed which required us to create floodwater. We had to draw upon various disciplines: not just digital compositing but also visual effects creation and fluid simulations,” said Thomas Magill.

Both teachers enthused that the directors were a pleasure to work with and the collaboration was smooth.

“The film has a very important social message to tell so it was rewarding in many ways to be able to contribute to this project. NAWI was a fantastic opportunity for our graduates to put their skills to the test on a full-length feature film,” said Tom Pugh.

Learning Lions and AIE look forward to seeing NAWI progress through two rounds of voting by members of the Academy of Motion Picture Arts and Sciences to narrow the list of submitted films down to five nominees for the Best International Feature Film.

About Academy of Interactive Entertainment (AIE)

AIE offers practical, career-focused courses delivered by industry-experienced teachers in 3D animation, game development, visual effects and film. Since 2019 AIE has sponsored scholarships to their Certificate and Diploma programs to Learning Lions student. AIE provided laptops and is supporting with opportunities at various gaming companies around the world for paid part-time and full-time work.

https://aie.edu.au/

About Learning Lions

Learning Lions is fighting poverty with digital opportunity. Established in 2015, Learning Lions equips local youth with essential IT and media skills, and empowering them to become entrepreneurs and self-sustaining individuals. By leveraging digital services, these aspiring entrepreneurs not only support themselves but also provide opportunities for others through employment and mentorship.

https://www.learninglions.org/

Media Contact

Neil Boyd, Academy of Interactive Entertainment, 61 434273190, neilb@aie.edu.au, https://aie.edu.au/

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SOURCE Academy of Interactive Entertainment

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Valhalla MSO Launches Impetus One to Enhance Valhalla Vitality’s Telehealth Platform

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September 20, 2024

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Valhalla MSO launches Impetus One, enabling healthcare providers to expand services, improve patient retention, and boost revenue with no upfront costs

MIAMI, Sept. 19, 2024 /PRNewswire-PRWeb/ — Valhalla MSO is excited to announce the launch of Impetus One (IO), a new software designed to power the Valhalla Vitality Network Provider Program. This initiative aims to expand the reach and capabilities of independent healthcare providers by offering an alternative to the traditional insurance model. With a focus on preventative medicine and wellness therapies, the platform is set to enhance patient care while creating new revenue opportunities for providers.

The Valhalla Vitality Network Provider Program addresses the gap created by insurance companies that often deny coverage for preventative medicine, wellness services, and even weight loss therapies. Insurance typically does not compensate healthcare providers for the time spent improving a patient’s overall health. Impetus One (IO) offers an alternative by providing a cash-pay marketplace where providers are fairly compensated for delivering impactful, life-changing services to their patients.

Key Benefits for Providers

Impetus One Software Integration: The platform integrates seamlessly with Valhalla Vitality, offering an e-commerce marketplace that connects patients with a wide range of health services. Providers can easily adopt the system to deliver therapies and other services, ensuring smooth payment processing and order fulfillment.No Upfront Costs: Providers can join the Network Provider Program without any initial fees. They simply share a unique link with patients, allowing for easy access to services, and payments are processed as orders are placed. Partner pharmacies handle medication shipments directly, creating a hassle-free experience for providers.Boosting Patient Retention: The platform includes a VIP Rewards Program, designed to increase patient retention and loyalty. Patients earn points for discounts and exclusive benefits, which encourages ongoing engagement and care continuity.E-commerce and Wellness Integration: Unlike typical affiliate programs, Valhalla Vitality allows providers to retain full control of their patient relationships. Providers can generate revenue through the integrated e-commerce system without worrying about referral fees or kickbacks, enabling them to focus solely on delivering high-quality patient care.

By joining the Valhalla Vitality Network Provider Program, healthcare providers gain access to a scalable model that helps increase profits, introduce new services, and enhance patient satisfaction. The VIP Rewards Program also strengthens the bond between patients and providers, making healthcare more accessible and rewarding for all.

Healthcare providers looking to grow their practices and increase revenue can join the Valhalla Vitality Network by visiting http://www.providevitality.com. Valhalla MSO’s new platform is a powerful tool for delivering advanced, patient-centric healthcare with a focus on accessibility and quality.

For more information, visit Valhalla Vitality at http://www.valhallavitality.com.

Media Contact

Chris K., Valhalla Vitality, 888-888-8888, ck@s99agency.com, https://valhallavitality.com/

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SOURCE Valhalla Vitality

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Ultima Markets Wins Two Prestigious Awards at Global Forex Awards–Retail 2024!

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September 20, 2024

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LIMASSOL, Cyprus, Sept. 19, 2024  /CNW/ — Ultima Markets, a leading global forex and CFDs brokerage, is thrilled to announce its double success at the prestigious Global Forex Awards – Retail 2024. The company won two distinguished awards: “Best Affiliates Brokerage – Global” and “Best Fund Safety – Global.”

The awards were presented during the event in Limassol, Cyprus, where Jean Philippe, Board Advisor, Corporate Governance and Sustainability at Ultima Markets, accepted the honours.

The Global Forex Awards – Retail has celebrated excellence in trading innovation for seven consecutive years. Ultima Markets’ dual wins reflect its commitment to quality, client-centric strategies, and strong partnerships across the financial services sector.

The “Best Affiliates Brokerage—Global” award recognises Ultima Markets’ exemplary affiliate programme, which has successfully driven its global expansion. It is celebrated for its transparency and competitive rewards tailored to affiliate needs.

Receiving the “Best Fund Safety – Global” award highlights Ultima Markets’ efforts to safeguard client assets. Through its partnership with Willis Towers Watson, the company provides up to USD$1,000,000 in insurance per account, while its Financial Commission membership ensures clients access to up to €20,000 in compensation funds.

These recognitions underscore Ultima Markets’ priority to security and transparency, including segregated accounts and robust risk management practices. The broker also assures affiliate partners of exceptional standards.

Commenting on the awards, Jean Philippe said, “These recognitions reflect the exceptional work of our teams to ensure the safety of traders’ funds and our dedication to creating value for our partners and clients. We will continue to evolve and innovate to meet the market’s demands.”

Ultima Markets is renowned for its extensive range of trading products and personalised customer service, designed to meet clients’ diverse needs worldwide. The dual recognition marks a significant milestone in the company’s global growth and reaffirms its reputation for delivering fund safety and robust affiliate opportunities.

“We are delighted to be recognised with these awards, which reflect our mission to create a secure trading environment and build strong, rewarding partnerships,” said Jack Li, Ultima Markets’ Regional Business Director.

About Ultima Markets

Ultima Markets is a fully licensed, fast-growing broker offering access to 250+ financial instruments. With a team of 2,000+ professionals in 15 global offices, we serve clients in 172 countries. Check out more about our awards on Facebook, X, Instagram, LinkedIn and YouTube.

 

 

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SOURCE Ultima Markets

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