BUSINESS INSIGHTS, PHARMACY MARKET
Cytel | February 09, 2023
On February 7, 2023, Cytel Inc., a provider of statistical software and advanced analytics in the life sciences industry, announced that GSK, one of the world's top biopharmaceutical firms, signed a three-year strategic agreement to increase GSK’s deployment of the clinical strategy platform Solara (R). This agreement will contribute significantly to the future development of the Solara platform. The platform can help GSK effectively align on trial goals, traverse trial uncertainties, and create pressure-tested clinical trial designs that reduce costs and expedite speed up to the market.
GSK began using Solara in early 2022 and has already profited from the platform in a variety of study design projects. Over 300 users have adopted Solara at the top 20 biopharma firms worldwide since its initial debut in 2021. It is also the recipient of the 2022 Fierce Life Sciences Award for Technology Innovation.
Solara blends Cytel's proprietary algorithms evolved over three decades with enormous cloud computational capacity to overcome limits in clinical trial planning and design. Clinical development teams use Solara to quickly generate thousands of trial models representing thousands of design variants. These are used to pressure-test dozens of trial uncertainties, including treatment effect and enrollment rate. The platform's high-speed processing capabilities simulate tens of millions of modeled events that might occur during trial execution in minutes. In addition, Solara's visualizations make it simple to review results and quantify scientific and business trade-offs.
The user-friendly interface and dynamic visualization of Solara provide a common language and workspace to facilitate a more data-driven and collaborative trial design process across clinical development functions.
About Cytel
Founded in 1987, Cytel is the leading provider of statistical tools and advanced analytics for the design and execution of clinical trials. It helps life sciences decision-makers to realize the full potential of their products. Its 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical firms transform insight into confident decisions, from navigating uncertainty to establishing value. The company has an unwavering dedication to scientific rigor and operational excellence, which is directed via its offices in the United Kingdom, North America, Europe, and Asia.
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RESEARCH, PHARMA TECH
Ionis Pharmaceuticals, Inc. | March 10, 2023
Ionis Pharmaceuticals, a leading RNA-targeted therapy firm, recently announced that the USFDA has accepted for review a new drug application (NDA) for eplontersen. Eplontersen is an investigational antisense medicine designed to reduce the production of transthyretin (TTR) protein and treat hereditary and non-hereditary forms of ATTR amyloidosis (ATTR).
The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of December 22, 2023. The FDA has declared that no review concerns were detected and made no new data requests. The FDA also stated that it does not intend to conduct a meeting of the advisory committee to discuss the application.
ATTR amyloidosis is a systemic disease caused by the accumulation of TTR protein in organs, leading to progressive organ damage and eventually death. Patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) experience ongoing debilitating nerve damage throughout their bodies, resulting in the progressive loss of motor function.
The NDA for eplontersen is based on results from the global Phase 3 NEURO-TTRansform study showcased at the International Symposium on Amyloidosis (ISA). In the study, eplontersen showcased a statistically significant and clinically meaningful change relative to the baseline for its co-primary and critical secondary endpoints compared to the external placebo group. In addition, Eplontersen also demonstrated a favorable safety and tolerability profile.
Ionis and AstraZeneca announced a strategic partnership to develop and commercialize eplontersen in December 2021. Eplontersen is being developed and commercialized jointly by both businesses in the United States and will be created and commercialized by AstraZeneca throughout the rest of the globe, except Latin America.
The FDA granted eplontersen Orphan Drug Designation in the United States in January 2022. Eplontersen is also being studied in the worldwide Phase 3 CARDIO-TTRansform trial for transthyretin amyloid cardiomyopathy (ATTR-CM), a systemic, progressive, and deadly disorder leading to progressive heart failure and death within 3 to 5 years after disease start.
About Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company headquartered in Carlsbad, California. Its unique antisense technology platform allows them to develop RNA-targeted therapies that modify the production of disease-causing proteins, leading to the development of treatments for rare genetic disorders, cardiovascular diseases, and neurodegenerative diseases. The company's most significant achievement is developing and commercializing Spinraza, the first approved treatment for spinal muscular atrophy. Ionis Pharmaceuticals has also developed drugs for other rare diseases, including transthyretin amyloidosis, Huntington's disease, and myotonic dystrophy type 1.
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BUSINESS INSIGHTS, PHARMACY MARKET
West Pharmaceutical Services, Inc. | February 01, 2023
On January 31, 2023, West Pharmaceutical Services, Inc., a global pioneer in novel injectable drug administration solutions, announced its participation in Pharmapack Europe 2023 in Paris, France, to demonstrate its leadership and insights on industry packaging and containment trends and challenges.
With the introduction of three new products, the company expands its innovations for its patients and customers worldwide - Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System, West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® SG EZ-fill® technology and FluroTec® 5-10mL Cartridge Plunger.
West Pharmaceutical Services Vice President and General Manager, Biologics Li Chen commented, "This year, we are introducing three new product solutions at Pharmapack." He added, "With these innovations, we are addressing the growing market needs for today's complex and sensitive molecules, including large-volume delivery and a complete vial containment solution that can protect and scale from development through commercialization."
(Source – PR Newswire)
Meanwhile, West's participation in this year's conference includes the following
Learning Lab - How Market Trends Drive Innovation and Enable the Pharmaceutical Pipeline on Wednesday, February 1, 2023
Panel Session - Innovation of Novel Medicines and Trends in Demand for Injectable Home and Self-Administration on Wednesday, February 1, 2023
Innovation Tours - West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® Technology on Wednesday, February 1, 2023
Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System on Thursday, February 2, 2023
About West Pharmaceutical Services, Inc.
Founded in 1923, West Pharmaceutical Services, Inc. is a market leader in developing and delivering innovative, high-quality injectable solutions and services. As a trusted partner to both established and emergent drug producers, it contributes to the safe, effective containment and distribution of life-saving and life-enhancing medications to patients. West Pharmaceutical supports its clients by supplying over 45 billion components and devices annually, with roughly 10,000 team members spread across 50 facilities globally. The company marks its 100th anniversary of growth and innovation in 2023, as well as the essential role it continues to play in healthcare and the patient experience. Headquartered in Exton, Pennsylvania, it had generated $2.83 billion in net sales for the fiscal year 2021.
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