U.S. states build stockpiles of malaria drug touted by Trump

Abcnews | April 26, 2020

State and local governments across the United States have obtained about 30 million doses of a malaria drug touted by President Trump to treat patients with the coronavirus, despite warnings from doctors that more research is needed. At least 22 states and Washington, D.C., secured shipments of the drug, hydroxychloroquine, according to information compiled from state and federal officials by The Associated Press. Sixteen of those states were won by Trump in 2016, although five of them, including North Carolina and Louisiana, are now led by Democratic governors. Supporters say having a supply on hand makes sense in case the drug is shown to be effective against the pandemic that has devastated the global economy and killed nearly 200,000 people worldwide, and to ensure a steady supply for people who need it for other conditions like lupus. But health experts worry that having the drug easily available at a time of heightened public fear could make it easier to misuse it. The U.S. Food and Drug Administration on Friday warned doctors against prescribing the drug, hydroxychloroquine, for treating the coronavirus outside of hospitals or research settings because of reports of serious side effects, including dangerous irregular heart rhythms and death among patients.

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Teva believes medicine should always be accessible, and we work to help make this a reality. We're working with Global HOPE (Hematology Oncology Pediatric Excellence), a non-profit

Spotlight

Teva believes medicine should always be accessible, and we work to help make this a reality. We're working with Global HOPE (Hematology Oncology Pediatric Excellence), a non-profit

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BUSINESS INSIGHTS, PHARMACY MARKET

Cytel and GSK Advance Clinical Trial Design with Solara

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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BUSINESS INSIGHTS, VIEWS AND ANALYSIS

Rancho BioSciences Welcomes BenevolentAI as Fifth Member of SCDS Consortium

Rancho BioSciences | February 02, 2023

On February 1, 2023, Rancho Biosciences, a leading provider of data sciences services, announced that BenevolentAI has joined the SCDS consortium as its fifth member. Rancho Biosciences launched its Single Cell Data Science (SCDS) pre-competitive consortium on February 26, 2022, with four Charter Members: Bristol Myers Squibb, Janssen Research & Development LLC, a subsidiary of Johnson & Johnson's Janssen Pharmaceutical Companies, Novartis, and Vesalius Therapeutics. The consortium's mission is to establish a uniform industry standard for creating and formatting single-cell datasets through a systematic effort to build data models and ensure that public data are curated consistently. Due to the evident impact of single-cell transcriptomics technology on drug discovery, pharmaceutical firms continue to adopt single-cell sequencing techniques at an exponential rate. The availability of ever-increasing volumes of single-cell datasets in the public domain enables pharmaceutical companies to vastly increase their universe of single-cell experiments over those generated internally. However, harnessing this enormous public data lake by locating, downloading, and curating single-cell data is difficult and time-consuming compared to the resources required for scientists to analyze data to derive value for biomedical research collectively. To date, Rancho has provided 83 analysis-ready datasets by using its extensive curation knowledge and expertise. Each dataset contains 79 columns of curated metadata that have been verified against a 4-entity data model developed by Rancho for SCDS. Based on member priorities, Rancho will continue to contribute a steady stream of harmonized single-cell datasets to the consortium. With this shared cost model, these may be supplied at a far higher throughput and much more cost-effectively than a single company could do. About Rancho BioSciences Founded in 2012, Rancho BioSciences is a global fee-for-service data curation firm that provides analysis and development services to clients, including pharma, foundations, government, and biotech. With a global team of qualified Ph.D. and Ph.D./MD scientists that provide high-quality work based on their expertise and domain knowledge in biology, diseases, and clinical data, it strives to find cures for diseases by serving its clients and saving lives through Data. It aims to be the world's leading provider of data services and harness domain skills and expertise to address complex problems.

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BUSINESS INSIGHTS, PHARMACY MARKET

Harrow Introduces Next-Gen Compounded Atropine Formulations

Harrow | February 16, 2023

On February 15, 2023, Harrow, a renowned pharmaceutical firm specializing in eyecare in the United States, announced the launch of its next-generation, patent-pending compounded Atropine formulations. These formulations are now accessible through ImprimisRx, a mail-order pharmacy subsidiary wholly owned by Harrow. The following are the key features of ImprimisRx's next-generation Atropine formulations Thoroughly validated analytical tests are conducted to ensure potency, consistency, and stability. The formulations are free of preservatives and boric acid. They possess a physiologic pH of 5.5. They can be stored at room temperature for up to 180 days. Eyecare professionals can purchase these compounded Atropine formulations for as less as $39 per 5mL bottle through various channels, such as online via atropine.com or by contacting ImprimisRx Customer Service at 615-437-4690 via call or text. Compounded formulations are recommended for patients with clinical requirements that are not met by FDA-approved medications. It is essential to note that compounded medications are not reviewed by FDA for their safety and effectiveness. ImprimisRx does not manufacture copies of products that are already available in the market. Harrow's Chairman and Chief Executive Officer, Mark L. Baum, commented, "Our mission has always been to help our eyecare professionals address their patients' unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer." (Source – Business Wire) About Harrow Founded in 2012, Harrow is a leading ophthalmic pharmaceutical firm in the United States focused on discovering, developing, and introducing accessible, innovative, and affordable prescription therapies. It holds commercial rights for ten FDA-approved eyecare pharmaceutical products. In addition, the company also operates ImprimisRx, a leading U.S. compounding business that specializes in ophthalmic medications and is licensed to ship prescription drugs in all 50 states. The success of its efforts is reflected in its remarkable financial performance, with a 72% compound annual growth rate achieved during our first eight years in operation. This phenomenal growth rate has established Harrow as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.

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