businesswire | September 26, 2023
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.
“Children with ADHD around the world need medications that provide fast-acting and long-lasting relief in a range of formulations that are easy for them to take. Since the launch of our Quillivant XR product in the United States, we have been approached by potential partners to make our portfolio of ADHD products available around the world,” said Ketan Mehta, founder and chief executive officer at Tris Pharma. “We are truly delighted by this milestone, which will make this important medication available to millions of patients in Canada.”
Ontario-based KYE Pharmaceuticals, Inc. will make Quillivant ER Oral Suspension and Quillivant ER Chewable Tablets available to patients in Canada beginning in Q1 2024. Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
ADHD is one of the most common neurodevelopmental disorders diagnosed among children. Many therapies approved to treat ADHD have well-established and significant drawbacks, including early symptom rebound, limited duration of release and efficacy, delayed onset, inability to customize or control titration, and patient difficulty taking the medications (e.g., children unable to swallow a tablet).
In Canada, Quillivant ER is authorized for administration to children aged 6 to 12 diagnosed with ADHD as a once-daily liquid suspension or as a chewable tablet to overcome the difficulty of swallowing pills while still achieving the duration needed to control ADHD symptoms for the desired timeframe. Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day. Quillivant ER Oral Suspension allows for personalized dosing with ease of titration and the Quillivant ER chewable tablets are scored tablets, which are ideal for pediatric patients, providing additional flexibility in dose administration with the most dosing options available in an extended-release methylphenidate tablet. Tris developed both formulations using the company’s proprietary LiquiXR® technology.
“Quillivant ER has the potential to address a significant unmet market need in the treatment of ADHD by overcoming drawbacks associated with many other ADHD medications, particularly among children,” said John McKendry, president at KYE Pharmaceuticals. “Our strategic partnership with Tris allows us to apply our extensive regulatory and commercial expertise to ensure this unique ADHD medication is made available to patients in Canada.”
About Tris Pharma
Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at www.trispharma.com and on LinkedIn @TrisPharma.
About KYE Pharmaceuticals
Kye Pharmaceuticals Inc. is a private company headquartered in Mississauga, Canada focused on bringing medications to the Canadian market which fulfill clinically significant and unmet needs. KYE has licensed many innovative products and was founded on an entrepreneurial spirit that optimizes our team’s strengths and brings unique value to our partners, Canadian healthcare professionals, and most importantly, patients across Canada.
Business Insights, PHARMACY MARKET
PRNewswire | August 09, 2023
Verista, a leading business and technology services company offering specialized solutions for the life sciences industry, is delighted to announce a new partnership with Sware. This collaboration underscores Verista's commitment to its clients to provide advanced and innovative digital validation solutions, helping them realize Pharma 4.0.
By incorporating Sware's Res_Q platform, clients can enhance, streamline, and optimize the flow of content and data, effectively addressing the challenges posed by static documents and disjointed workflows in the validation discipline. Together, Verista services and Res_Q provide a powerful combination, offering customers a comprehensive and efficient risk-based approach to validation processes in the life sciences industry.
"In this partnership, Verista will drive the efficient execution of digital transformations with Res_Q enabling clients to modernize their processes and leverage the latest regulated technologies in compliant ways," says Manny Soman, CEO of Verista. "We are delighted that Verista and Sware share the same goal to reduce and manage validation efforts while helping clients unleash the full potential of digital transformation to bring their products to market more quickly and safely."
"Digitizing the validation process is crucial for compliance-focused life sciences companies to be able to meet stringent global regulatory requirements, but digitizing processes means much more than putting paper processes on glass," says Bryan Ennis, Co-Founder and CEO of Sware. "Our partnership with Verista couples our deep digital technology expertise with robust industry experience to deliver the most comprehensive, intelligent and digital validation solutions on the market today."
Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from clinical to commercialization, manufacturing and distribution. Verista's experts continually deliver consistent, safe, and high-quality results across the product development lifecycle in the areas of enterprise and lab solutions, technology solutions, manufacturing solutions, and regulatory compliance and product management.
Sware is changing how the life sciences industry manages validation – helping companies deliver safer therapies through better technology. Sware provides one validation solution crafted specifically for the entire life sciences industry. Res_Q by Sware automates validation – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems.
prnewswire | September 01, 2023
Evolution Health Group (EHG), a leading name in medical communications, pharmaceutical strategic marketing, and digital solutions, unveiled its game-changing technology platform, 360Connex®, set to redefine the landscape of stakeholder engagement. The primary objective of this robust platform is to enable enterprises to scale and target their engagement initiatives effectively. With a focus on efficiency, transparency, and actionable insights, organizations can now make data-driven decisions and foster stronger relationships with their stakeholder communities.
This state-of-the-art platform is geared towards three core functionalities
Management, Monitoring, and Measurement of Stakeholder Engagement: Through an intuitive interface and innovative technologies, enterprises can now efficiently manage, track, and measure the impact of their interactions with their key stakeholders, streamlining the collaboration process and helping teams focus their resources and strategies to ensure maximum impact on the business.
Facilitation of Speaker Programs: The platform offers tools that will not only simplify the coordination and execution of speaker programs, but also ensure they meet the highest standards of content delivery and engagement.
Application of Advanced Analytics: By harnessing the power of artificial intelligence, machine learning, and advanced automation technologies, EHG's 360Connex® platform offers unprecedented insights and optimization opportunities. This ensures that engagement activities are not only scaled, but also aligned with the dynamic needs of the stakeholder community. The platform is designed to meet the differing needs of emerging organizations through the largest of enterprises.
"The healthcare community is rapidly evolving, and traditional methods of engagement are no longer sufficient. Our new technology platform bridges the gap, empowering enterprises to create more impactful, meaningful, and measurable interactions with their key stakeholders in a cost-effective way that ensures ongoing transparency and accountability," commented Carolyn Vogelesang Harts, one of the Managing Partners of Evolution Health Group.
The unveiling of 360Connex® comes at a pivotal moment in the healthcare industry. As interactions between enterprises and healthcare professionals become increasingly intricate, there is a pressing need for systems that simplify processes and provide actionable insights. EHG's 360Connex® platform is the answer to this pressing demand.
This innovation is poised to usher in a new era of insight-driven engagement, ensuring that healthcare companies not only keep pace with, but also anticipate the needs of, their diverse professional audiences.
About Evolution Health Group
Founded in 2005 and based in Pearl River, NY, Evolution Health Group stands at the forefront of pharmaceutical strategy, marketing, and digital solutions for global healthcare companies. EHG provides distinctive services through three main divisions; Evolution Medical Communications for medical and scientific strategy, blulava, for technology and digital solutions, and Maestro360 for speaker program logistic management.