NICE lowers threshold for blood pressure drugs in new guidance

pharmaphorum | August 28, 2019

New guidelines on the management of high blood pressure in the UK will see thousands more patients eligible to start drug treatment earlier, with the aim of preventing heart attacks and strokes. The new guidance on the treatment of hypertension lowers the cardiovascular disease (CVD) risk threshold to stage 1 high blood pressure – for anyone aged under 80 with a 10-year risk of 10% or more and a blood pressure reading of at least 140/90. Stage 1 hypertension is diagnosed when there is no simple identifiable cause of the raised blood pressure – NICE noted that the hypertension may be related, in part, to obesity, dietary factors such as salt intake, physical inactivity or genetic inheritance. NICE says that is a reduction from the 20% CVD risk threshold in the 2011 guideline which the new document updates, and it is estimated that more than 700,000 patients in England and Wales could now be eligible for drug treatment. At the moment, it is thought that around half of people diagnosed with stage 1 hypertension and risk below 20% are being treated with blood pressure drugs. The changes were proposed earlier this year and almost immediately led to pushback from the British Medical Association (BMA), which said they would dramatically increase the workload of doctors in primary and secondary care. In a letter to NICE guideline committee chair Professor Anthony Wierzbicki, the BMA said in April it was concerned that the plan “has been made on an economic model of cost-efficiency based on the treating of populations, rather than treating patients as individuals” and that the benefit for treating stage 1 hypertension was unproven.

Spotlight

Did you know that two third of British adults say they cannot sleep if they are forced to change sides in the bed? Did you know that 22% of UK couples already sleep in separate bedrooms because of each other bad habits? Did you also know that snoring is only the third biggest cause of complaint in the bedroom? The biggest cause of complaint is, in fact, your partner holding on to the edge of the duvet and rolling away from the other leaving you in a cold bed.

Spotlight

Did you know that two third of British adults say they cannot sleep if they are forced to change sides in the bed? Did you know that 22% of UK couples already sleep in separate bedrooms because of each other bad habits? Did you also know that snoring is only the third biggest cause of complaint in the bedroom? The biggest cause of complaint is, in fact, your partner holding on to the edge of the duvet and rolling away from the other leaving you in a cold bed.

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BUSINESS INSIGHTS

Cosán and Genomind Partner to Help Prevent Adverse Prescription Drug Events for Older Adults

Cosán and Genomind | July 20, 2022

Cosán, a provider of technology-driven preventative care services for older adults and the physicians that support them, and Genomind, a leading precision healthcare company, have partnered to fill an existing gap in aging adult care management by providing Cosán’s network of physicians with Genomind’s integrated precision medication management platform. The platform will provide insights that will help Cosán to achieve the best outcomes for their patient population, prevent adverse drug events and reduce avoidable costs of medication mismanagement. With over 40% of U.S. adults 65 years of age and older taking five or more prescription medicines, aging populations are at high-risk for adverse drug events. Through this partnership, Genomind’s analytic capabilities will provide Cosán with risk stratification insights, enabling Cosán clinicians to target individuals that are most likely to benefit from medication reviews and pharmacogenetictesting, also known as drug-gene testing. Genomind’s PGx test adds a layer of precision medicine that leverages genetics to help providers select appropriate medications and dosing. Equipped with advanced pharmacogenetic screening, clinical concierge services and access to expert pharmacists, Cosán’s care teams can then incorporate individualized insights into each patient’s chronic care management plan so medications are administered safely. “This partnership brings a new level of pharmacy and genetic expertise to the thousands of providers and the patients they support, marking yet another stride in the delivery of effective preventative care management services. These unique drug analytic and genetic testing capabilities provide Cosán’s network of physicians and care coordinators with another tool designed to help eliminate avoidable drug risks and improve overall care quality for vulnerable patients receiving care from their homes.” David Hunt, Founder & President at Cosán According to the CDC, adverse drug events cause approximately 1.3 million emergency department visits each year, and older adults are nearly seven times more likely to end up hospitalized after such events than younger persons. Many of these adverse events are caused by just a few drugs. This new platform will help physicians develop personalized therapeutic approaches for patients based on their individual genetic makeup and are designed to improve patient and physician satisfaction and reduce medical expenses. With the recent expansions by Medicare to cover PGx testing in certain circumstances, this population is particularly suited to dramatically benefit from this platform. “The prevalence and cost of medication mismanagement is unacceptable, costing thousands of lives and billions of dollars annually. We’re thrilled to join Cosán in helping to improve care management for older adults, who are at high risk for these adverse drug events,” said Cynthia Kilroy, Co-CEO, Genomind. About Cosán Group Cosán Group, established in 2015, is an industry-leading healthcare organization creating new pathways to modern aging with technology-driven preventative care services, offering concierge home care for older adults. Early market exposure in the delivery of technology and services to support the Chronic Care Management (CCM) program, and Behavioral Health Integration (BHI) programs with Remote Patient Monitoring (RPM) has propelled Cosán to deliver a practice and patient-centric approach to remote care coordination. About Genomind Genomind is a leading precision health company focused on optimizing the treatment experience for individuals and healthcare providers through actionable genetic insights and innovative health technology. Genomind’s platform integrates precision health technology and pharmacogenetic testing on an individual and population level beyond mental health. Built on the foundation of compassionate care and clinical expertise, Genomind is empowering a more targeted and personalized approach to medication management and supporting providers in a new standard of care.

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BUSINESS INSIGHTS

Mission Bio Announces Pharma Assay Development Services for Solid Tumor Research

Mission Bio | July 13, 2022

Mission Bio, Inc., the pioneer in high-throughput single-cell DNA and multi-omics analysis, announced the launch of solid tumor assays through its Pharma Assay Development services. The availability of this new service offering will help to accelerate the development of cancer therapeutics by reducing the time and cost associated with the characterization of solid tumor cells. Precision therapeutics for solid tumors have been historically bottlenecked due to technical challenges associated with the ability to deeply profile thousands of individual cells for a rich characterization of tumor evolution and heterogeneity. This must be done at a much higher resolution compared to bulk next-generation sequencing to enable detection of rare events, at a much earlier stage before progression. Utilizing Mission Bio's Tapestri™ platform, the company's PAD services for solid tumors partner with researchers to provide high-resolution data to unmask the underlying genetic diversity across cell populations. Insights into the clonal landscape and co-occurrence of mutations enable improved patient stratification for clinical trials and the identification of druggable targets for precision therapeutics. Researchers can also monitor treatment resistance by analyzing the acquisition of rare mutations driving tumor progression over the course of treatment. The expansion of Mission Bio's PAD services to solid tumor research comes just three months after the launch of the Solid Tumor Solution on the Tapestri™ Platform, demonstrating Mission Bio's commitment to continuously developing innovative single-cell technologies for its pharma customers. "We have seen tremendous uptake and interest from top-tier pharma companies for our blood cancer Pharma Assay Development program, and we expect the same momentum for our solid tumor services. With our solid tumor services, Mission Bio partners with pharma customers to elucidate the mechanisms of drug resistance through mutation acquisition, determine how cells transform from benign to malignant states, and reveal the genomic changes enabling cancer cells to metastasize – without having to bring single-cell technology or resources in-house. From a customer's perspective, it is as easy as shipping out samples and getting a fully analyzed report back." Todd Druley, MD, PhD, Chief Medical Officer of Mission Bio Mission Bio's PAD services deliver comprehensive support across the therapeutic development process. The company has a dedicated team that works with researchers to develop assays, identify high-impact samples, and analyze the data. As part of the service, pharma partners have access to Mission Bio's innovative technology, assay development team, R&D organization, and bioinformatics support. About Mission Bio Mission Bio is a life sciences company that accelerates discoveries and cures for a wide range of diseases by equipping researchers with the tools they need to better measure and predict our resistance and response to new therapies. Mission Bio's multi-omics approach improves time-to-market for new therapeutics, including innovative cell and gene therapies that provide new pathways to health. Founded in 2014, Mission Bio has secured investment from Novo Growth, Cota Capital, Agilent Technologies, Mayfield Fund, and others. The company's Tapestri™ platform gives researchers around the globe the power to interrogate every molecule in a cell together, providing a comprehensive understanding of activity from a single sample. Tapestri™ is the only commercialized multi-omics platform capable of analyzing DNA and protein simultaneously from the same sample at single-cell resolution. The Tapestri™ Platform is being utilized by customers at leading research centers, pharmaceutical, and diagnostics companies worldwide to develop treatments and eventually cures for cancer.

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PHARMACY MARKET

CASI PHARMACEUTICALS ANNOUNCES EXIT OF JUVENTAS INVESTMENT TO STRENGTHEN BALANCE SHEET

CASI Pharmaceuticals, Inc. | September 26, 2022

CASI Pharmaceuticals, Inc. a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products announced that CASI Biopharmaceuticals Co., Ltd, a subsidiary of CASI Pharmaceuticals, Inc. entered into an Equity Transfer Agreement with Shenzhen Jiadao Gongcheng Equity Investment Fund, LLP pursuant to which CASI Wuxi agreed to transfer its equity interest in Juventas Biotechnology Co., Ltd. amounting to 12.0098% total Juventas equity to Jiadao Gongcheng for RMB 240.87 million. The Equity Transfer Agreement states there will be two even payment installments from Jiadao Gongcheng; one payment to be made after the Equity Transfer Agreement is signed and the second payment to be made after the completion of the equity transaction. "We are confident in CNCT-19, and we expect Juventas to submit for NDA to the NMPA in 2022 for the B-ALL indication. CASI and Juventas will continue to maintain a working partnership, focusing on product launch and co-marketing for CNCT-19." Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer Dr. He continued, "The completion of the equity transfer transaction will strengthen CASI's balance sheet by providing CASI with sufficient cash to operate until, at least, the end of 2023. This transaction will allow CASI to advance the development of our other pipeline projects while augmenting the efforts of our sales and marketing team." About CNCT-19 CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. CD19- targeted CAR constructs from several different institutions have demonstrated consistently high antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma. CD19 antigen is the most frequently used target in the CAR-T cell therapy clinical trials for hematological malignancies such as leukemia and lymphoma. Juventas is responsible for the development of CNCT19. CASI and Juventas will co-commercialize CNCT19 under the direction of the program's joint steering committee. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals Co., Ltd., located in Beijing, China. The Company has built a commercial team of more than 100 hematology and oncology sales and marketing specialists based in China. About Juventas Juventas is a biopharmaceutical company headquartered in China dedicated to the development and commercialization of cell therapies globally. Utilizing innovative and integrated technology platforms, the company has developed a diverse pipeline of cellular immunotherapies for treatment of hematological malignancies, solid tumors, and other non-oncological conditions both in China and globally. At present, the company is conducting two pivotal clinical trials of CNCT19 for treating adult r/r-B-ALL and r/r-B-NHL in China. CNCT19 has the potential to become the first launched domestically developed CD19 CAR-T therapy in China and the first CAR-T product for the treatment of adult R/R B-ALL in China.

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