FDA greenlights first generics of blood thinner

in-PharmaTechnologist.com | January 06, 2020

FDA greenlights first generics of blood thinner
Eliquis (apixaban) is an anticoagulant used for the treatment of blood clots and prevention of stroke in people with nonvalvular atrial fibrillation, marketed by Bristol-Myers Squibb and Pfizer. Indications of the drug product also include the prevention and treatment of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery. ​A blockbuster drug,​, Eliquis brought BMS sales of over $5.9bn (€5.2bn) in the first three quarters of 2019. The approved generic versions are not projected to enter the market soon, as Eliquis is protected by patent until 2026.During a Q3 earnings conference call, Giovanni Caforio, BMS’ CEO, commented that the company has reached settlements with over 20 other developers of apixaban, however.

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This white paper explores a number of ways that today’s modern, laboratory-based  PXRD instrumentation and advanced software can greatly assist pharmaceutical scientists in their quest to develop high quality, stable products and accelerate their speed to market. All applications described and many more can be performed on a single PXRD instrument.

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RESEARCH

Biognosys Launches Next-Generation Blood Biomarker Discovery Solution

Biognosys | November 10, 2021

Biognosys, a leader in proteomics solutions for drug discovery and development, announces the launch of its next-generation blood biomarker discovery solution, which will be offered as a contract research service. The service is designed to help researchers decipher the complexity of the blood proteome and unlock unbiased discoveries for pharma and diagnostics development and precision medicine. The launch will feature a series of events and resources that detail the science and technology behind the new solution, as well as its applications Launch webinar on November 9, entitled: “Plasma Proteomics: The Next Frontier of Biomarker Discovery in the Precision Medicine Era.” Presentation and exhibition at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12-14 in Washington, D.C. The new service offers unprecedented depth, quantitative precision, and throughput for discovery research. The solution will search the complete plasma proteome to quantify up to 3,000 of the most relevant proteins and measure tens of thousands of peptide-level datapoints to provide a deep understanding of key disease pathways. The solution can be applied across all biological species and to any other biofluid, such as cerebrospinal fluid or urine. In addition to the biofluid biomarker discovery service, an improved tissue biomarker discovery service is available, offering an industry-leading depth of 10,000 proteins. Both solutions are based on Biognosys’ proprietary, patented Hyper Reaction Monitoring (HRM™) technology and its optimized Liquid Chromatography - Mass Spectrometry (LC-MS) workflow. The clinical transferability of this technology allows quick transition from early stage discovery to specific, targeted panels that can be applied in a regulated setting. Kanna Palaniappan, PhD, Staff Scientist at Freenome, a company that develops blood tests for early cancer detection, powered by a multi-omics platform, testifies: “We have used Biognosys’ services for a number of biomarker discovery studies focused on improving cancer detection, taking advantage of their constantly improving platform, and their ability to run large-scale studies while maintaining high data quality. We have had a valuable and productive relationship and we look forward to future collaborations.” “We are thrilled to offer customers our innovative, next-generation biomarker discovery solution and enable them to gain biological insights beyond what pre-defined panels can provide. By diving deep into the plasma proteome with an unbiased view, we profile the proteins that are of highest relevance to our customer’s disease areas of focus. This is what we call true discovery.” Kristina Beeler, PhD, Chief Business Officer of Biognosys Lukas Reiter, PhD, Chief Technology Officer of Biognosys states: “Mass spectrometry-based proteomics is the ideal tool to explore the blood proteome in an unbiased manner. Our continuous R&D improvements have enabled us to reach an unprecedented depth to quantify the very low abundant protein ranges that are of highest biological significance, while ensuring high scalability for clinical research.” About Biognosys Biognosys is a leader in next-generation proteomics, dedicated to transforming life science by inventing and developing cutting-edge proteomics technology and solutions and making them widely available for pharmaceutical and biotechnology researchers and proteomics experts. The Company offers a versatile portfolio of proprietary proteomics services, software, and kits that provide a multi-dimensional view of protein expression, function, and structure in all biological species and sample types. Biognosys’ unique, patented technologies utilize high-resolution mass spectrometry to quantify thousands of proteins across thousands of samples with industry-leading precision, depth, and throughput. Through advanced data analytics, Biognosys translates data into actionable insights for R&D and clinical research.

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Zeblok Computational Announces Partnership with Laufer Center and CEWIT - COVID-19 Drug Discovery

Zeblok Computational, The Laufer Center, CEWIT | July 20, 2020

Zeblok Computational is contributing to the efforts of two groups of researchers at The Laufer Center for Physical and Quantitative Biology, for COVID-19 drug discovery by providing Zeblok’s secure, scalable Supercomputing-as-a-Service platform, employing 128 GPUs from the CEWIT SMART GPU Cluster. The Laufer Center simulations focus on 3 key proteins of the SARS-CoV-2 virus to pinpoint more precisely which drug candidates have the best binding affinity to various protein targets: The RNA-dependent RNA polymerase (which copies the virus inside the cell, thought to be the target of Gilead’s Remdesivir, now in clinical trials) The Protease (which chops up the virus proteins into the right pieces) The spike protein (which is how the virus unlocks the door to enter the cell).

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PHARMACY MARKET

Sensyne Health and Phesi Form a Joint Commercial Development Partnership with a Leading Pharmaceutical Company

Sensyne Health, Phesi | May 24, 2021

Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc. Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client. This collaboration's financial terms have not been disclosed. About Sensyne – Phesi Strategic Alliance Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients. About Sensyne Health Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines. About Phesi Inc. Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.

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Spotlight

This white paper explores a number of ways that today’s modern, laboratory-based  PXRD instrumentation and advanced software can greatly assist pharmaceutical scientists in their quest to develop high quality, stable products and accelerate their speed to market. All applications described and many more can be performed on a single PXRD instrument.