AbbVie receives US regulatory approval for Mavyret

AbbVie has received the US Food and Drug Administration (FDA) approval for Mavyret (glecaprevir / pibrentasvir) to lower the therapy period from 12 to eight weeks in hepatitis C (HCV) patients with cirrhosis. The indication for once-daily therapy is meant for treatment-naïve, compensated cirrhotic, chronic HCV patients across all genotypes (GT1-6). Previously, the drug secured FDA approval in August 2017 for eight-week, pan-genotypic therapy for treatment-naïve HCV patients without cirrhosis. Mavyret is a ribavirin-free medication that consists of 100mg glecaprevir in combination with 40mg pibrentasvir. Glecaprevir is an NS3 / 4A protease inhibitor, while pibrentasvir inhibits NS5A. AbbVie discovered glecaprevir as part of its ongoing alliance with Enanta Pharmaceuticals, which focuses on HCV protease inhibitors and regimens, including protease inhibitors.

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Evolution Health Announces Revolutionary Technology Platform to Transform Stakeholder Engagement and Actively Measure Their Impact for Pharmaceutical

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.

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PHARMACY MARKET

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment

Business Wire | 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.

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Cytel continues expansion of market access and medical communication capabilities with the acquisition of co.faktor

Business Wire | September 28, 2023

Cytel Inc., provider of quantitative insights and health data analytics to leaders in the life sciences, has acquired the Berlin-based company co.faktor GmbH with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. As a result, Cytel’s services for biopharma commercialization will gain new and complementary specialist consultancy capabilities and localized expertise for successful market access in Germany, a first wave launch country. The acquisition marks another milestone in Cytel’s strategic growth in Europe, and follows the recent acquisition of stève consultants, specialists in market access, real-world evidence (RWE), and health economics and outcomes research (HEOR) in France. Cytel now boasts a 200-person-strong access consultancy team, making it one of the only providers that offers the full fleet of advisory services, from clinical trial and real-world data and evidence analytics to global market access and local in-country Health Technology Assessment (HTA) support. Cytel is now primed to provide global drug sponsors and their affiliate teams with advanced analytical support across the lifecycle through commercialization. Achieving favorable market access in today’s global healthcare industry is challenging and requires deep knowledge of EU national regulations. Cytel has long excelled at using proven quantitative techniques to help pharmaceutical manufacturers successfully enter new markets. To continue supporting global and local clients on their road to commercial success, Cytel has invested heavily in specialized, national capabilities in key launch markets with the recent acquisitions of stève consultants in June 2023 and SDS Life Sciences in 2022. Cytel’s most recent acquisition of the co.faktor businesses continues this investment, augmenting and extending localized regulatory support through product launch and commercialization. “The co.faktor team is recognized as a highly specialized biopharma services provider, with a broad spectrum of services including HTA, pricing, medical communication, patient relations, and strategic consultancy in Germany. It’s no surprise they’ve shaped the field there,” said Radek Wasiak, General Manager, Real-World & Advanced Analytics at Cytel. “We look forward to welcoming them to Cytel, where they will now be supported by the full depth and breadth of our unparalleled biometrics, RWE, HEOR, and market access advisory talent.” “Cytel and co.faktor have clear synergies, particularly when it comes to Cytel’s data know-how and co.faktor’s understanding of Germany’s uniquely complex market access and HTA requirements,” said Dr. Marc Esser, CEO, co.faktor. “By combining our deep expertise in the German HTA process with Cytel’s unique capabilities, we will be able to help our clients survive the upcoming European Health Technology Assessment (EU-HTA), a key challenge for all stakeholders in the European pharma market.” About Cytel Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence, and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,900 resources across North America, Europe, and Asia. About co.faktor For more than ten years, Berlin-based co.faktor GmbH has been providing specialized consulting services with its dedicated healthcare consultancy services co.value® (market access), co.medical® (medical communications), and co.patient® (patient relations) concentrations. By synergistically combining the expertise in these areas, co.faktor offers efficient launch support with consistent messaging to all relevant stakeholders.

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