Mercks new combo med Recarbrio fights resistant bacteria. Can it tackle the sales challenge, too?

fiercepharma | July 17, 2019

Merck and Co. is one of the few large drugmakers still pursuing antibacterial R and D, and on Wednesday, the company scored approval for a combo drug that tackles serious urinary tract and abdominal infections when other treatments don't work. The FDA signed off on Merck’s Recarbrio, which adds a new infection-fighter, relebactam, to a previously approved combo of cilastatin and imipenem. The three-ingredient combo med has a green light to tackle infections in adults caused by specific gram-negative bacteria. Merck's newest nod comes on the heels of a Zerbaxa label expansion last month. The FDA added certain types of pneumonia to Zerbaxa's list of approvals in complicated UTIs and abdominal infections. The label boost gives Zerbaxa, acquired in Merck's $8.5 billion Cubist buyout, a chance to make up for early sales shortfalls. Zerbaxa's marketing struggles show one reason why so many drugmakers are abandoning anti-infective research, even at a time when the need for new meds is so great. Speaking with FiercePharma earlier this summer, Merck’s associate vice president in infectious disease clinical research Dr. Joan Butterton said antibacterial resistance is “one of the great public health challenges of the modern era.” Recarbrio itself illustrates that challenge; it was developed to address imipenem's waning effectiveness. Adding relebactam to the mix restores bacteria's susceptibility to imipenem, a spokeswoman said. Imipenem and cilastatin have been approved in combo for decades as Primaxin.

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BC Platforms Adds Japans Mitsubishi Space Software to its Global Data Network

BC Platforms | February 21, 2022

BC Platforms (BCP), a global leader in healthcare data management and analytics, announced a new data partnership with Japan's Mitsubishi Space Software Co. Ltd. (Mitsubishi), one of the country's oldest bioinformatics companies. The collaboration, which provides secure access to Mitsubishi's cancer specific cohort of 8,000 patients, will accelerate the provision of cancer genetic data analysis services to medical institutions for cancer research. As part of the collaboration, Mitsubishi joins BCP's BCRQUEST network, which is revolutionizing drug development & personalizing care. This global, federated data partner network enables analytics and deeper insights. BCP has built this network, which reaches over 22 million patient lives in the catchment area, and data partners across Europe, North America, and Asia-Pacific to enable the realization of the full potential of real-world data. "At BCP, our mission is to accelerate the translation of research into global clinical practice through the faster generation of translatable, actionable, research insights. We encourage health systems to invest in consenting and data infrastructure as it provides strong foundations underpinning personalized medicine and ultimately improve outcomes for patients. Through our partnership with Mitsubishi, a long-standing leader in the field of bioinformatics, we expect patient lives will be directly, positively, impacted. This collaboration also adds significant data from millions of Asian patients to fuel research with connections to 30 hospitals in Japan. Such achievements are part of our continued efforts to scale our vision to build the world's leading analytics platform for healthcare and the life sciences industry." Nino da Silva, Deputy Managing Director, BCP Mitsubishi Space Software Co., Ltd., commented, "At Mitsubishi, we have long been supporting patients by utilizing and researching genomic research and providing cancer genetic data analysis services to medical institutions for cancer research. We are looking forward to working with BC Partners, and its BCRQUEST network, to enhance Japan's provision of clinical and genomic datasets to benefit research, patient care and personalized medicine." This latest data partnership builds on recent successes of delivering industry-leading interpretation services on genomics related insights, including pharmacogenomics in clinical practice in Asia and around the world. In October 2021, BCP announced its partnership with Bumrungrad International Hospital (BIH), in Bangkok, Thailand, one of the largest private hospitals in Southeast Asia and a world leader in healthcare delivery and pioneering clinical research. BCP is supporting BIH on its transition from single-gene tests to multi-gene panels for clinical pharmacogenetics, providing data interpretation support on single nucleotide variations. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalized medicine, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalized care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information. Additionally, BC Platforms has developed a Global Data Partner Network BCRQUEST.com, which allows us to access real-world data equivalent to approximately 22 million patient lives, including longitudinal clinical data in addition to 500k patients' genetic data, across 14 countries in Europe, North and South America, Asia and Africa, providing rich data for pharmaceutical and medical research and development. About Mitsubishi Space Software Mitsubishi Space Software was established in 1962 as a system engineering company. Our cooperate mission is "We support future society with high-quality and highly reliable solutions based on advanced science and technology which are cultivated by space system development."

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Cyclenium Pharma and Vuja De Sciences Announce Oncology Drug Discovery Collaboration

Cyclenium Pharma | January 06, 2022

Cyclenium Pharma, Inc. an emerging pharmaceutical company specializing in the discovery and development of novel therapeutic agents based on their proprietary macrocyclic chemistry, and Vuja De Sciences, Inc. a biotechnology startup dedicated to discovering therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence, have announced today the signing of a drug discovery collaboration agreement. The companies will screen and optimize lead candidates to advance treatments uniquely suited for preventing cancer metastatic recurrence, the biggest unmet need in oncology. The collaboration will exploit Vuja De’s proprietary anti-metastatic progression in vitro and ex vivo drug discovery screening platform and Cyclenium’s proprietary QUEST™ Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against dormant disseminated tumor cells for the prevention of metastatic cancer recurrence. Vuja De will be responsible for all screening efforts, while Cyclenium will be responsible for all medicinal chemistry efforts to generate new optimized macrocyclic compounds by employing its unique CMRT™ Technology. “We are very excited about entering this collaboration with Vuja De. We are confident that our CMRT™ Technology and proven success in the macrocycle area combined with the innovative anti-metastatic progression platform and excellent research team at Vuja De will enable the discovery and development of novel macrocyclic therapeutic agents to effectively control metastatic progression.” Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium “We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform that is based on over 20 years of pioneering experience in small molecule macrocyclic chemistry,” said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. “We are very pleased to work with Cyclenium on identifying and developing novel game-changing drug candidates that prevent metastatic recurrence, the most urgent need of most cancer patients,” he added. About Cyclenium Pharma Cyclenium Pharma is an emerging, privately held pharmaceutical research and development company exploiting its proprietary next generation CMRT™ macrocyclic drug discovery technology for the discovery and development of novel small molecule therapeutic agents to address areas of unsatisfied medical need. Cyclenium is creating value through progression of internal programs in oncology, infectious diseases and inflammation/pain. In addition, Cyclenium is providing its extensive experience and exploring its CMRT-based QUEST™ screening library in risk-sharing partnerships with leading academic and research driven non-profit organizations, as well as collaborations with innovative pharmaceutical and biotechnology companies world-wide seeking to modulate unique and difficult disease targets in diverse therapeutic areas. About Vuja De Sciences Vuja De is a biotechnology startup company dedicated to discovering and developing therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence. This vulnerability of DTCs stems from their dependence on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined “Metastatic Endurance”. ME enables DTCs to persist undetected at secondary sites like “ticking time-bombs” and eventually start to rapidly divide and form overt deadly tumors. We successfully created the first-ever cell-based and ex vivo drug screening platform that finds drugs that target ME. We are using the largely adolescent, orphan disease, osteosarcoma, as the best proof of concept model for developing anti metastatic progression drugs for many cancers such as breast, melanoma and kidney. We are testing repurposed drugs that have previously been in clinical trials, as well as novel preclinical drugs. About Osteosarcoma Osteosarcoma is an aggressive cancer of the bone and is the most common type of bone cancer in children and teens. Since metastatic recurrence has shared biological mechanism in many other cancer types, therapies that show promise in osteosarcoma can be developed in parallel for many other cancer types, such as breast, kidney and melanoma. Despite successful control of the primary osteosarcoma tumors and follow-up chemotherapy, metastasis continues to be the most common cause of mortality. The last 30 years have brought little improvement in survival outcomes for children with osteosarcoma, despite intensification of therapy. Due to lack of improved outcomes, new approaches to therapy are highly needed. Furthermore, if targeted therapeutics are found to prevent metastasis in this cancer, a strong biological rationale would exist for the evaluation of such a therapy in other human cancers.

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Labcorp Enhances Clinical Trial and Drug Development Capabilities Through Real World Data Collaboration With HealthVerity

Labcorp® | June 23, 2022

Labcorp® a leading global life sciences company, announced a new collaboration with HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data that will expand Labcorp’s comprehensive, end-to-end drug development and clinical trial programs. HealthVerity’s IPGE platform, an integrated technology and RWD infrastructure, enables Labcorp Drug Development and other participating companies to access fully interoperable, HIPAA-compliant data from the U.S.’s largest ecosystem1 of health care and consumer data. “This collaboration allows Labcorp to expand existing end-to-end solutions for drug and diagnostics development, commercialization and clinical trial efforts to include large-scale access to real-world data for research applications. By applying advanced analytics, Labcorp can help its clients improve their processes and reach better outcomes. Our substantial repository of test results can also help study sponsors more quickly and accurately assess patient eligibility for clinical trials, enroll patients faster and accelerate the availability of new medicines.” Dr. Paul Kirchgraber, CEO of Labcorp Drug Development Now more than ever, study sponsors are seeing the potential of RWD to yield longitudinal patient insights before, during and after trials. With more predictive analytics and artificial intelligence applications requiring comprehensive and fully interoperable RWD, Labcorp can align de-identified patient data with ten times greater accuracy2 than industry alternatives by using the HealthVerity IPGE platform. In addition, access to HealthVerity’s RWD with on-demand de-identification and data linkage capabilities reinforces Labcorp’s ability to be a trusted source of information for its clients. "Fragmentation of patient data is at an all-time high, and the goal is no longer just connecting this data," said Andrew Kress, CEO of HealthVerity. "Rather, the goal is making data more accessible and useful for gaining a detailed understanding of patient journeys. With analytics and applications requiring more frictionless access to the data itself, the HealthVerity IPGE platform stands alone in offering the ability to combine transaction-level patient data in a de-identified, fully interoperable manner, and delivering it directly into the client's applications of choice." About Labcorp Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. About HealthVerity Pharmaceutical manufacturers, payers, and government organizations have partnered with HealthVerity to solve some of their most complicated use cases through transformative technologies and real-world data infrastructure. The HealthVerity IPGE platform, based on the foundational elements of Identity, Privacy, Governance, and Exchange, enables the discovery of real-world data across the broadest healthcare data ecosystem, the building of more complete and accurate patient journeys and the ability to power best-in-class analytics and applications with flexibility and ease. Together with our partners, HealthVerity has built the modern way to data for the health insights economy.

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