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

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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RESEARCH

DotLab announces top-tier, global pharmaceutical research clients for its DotEndo platform

PR Newswire | January 09, 2024

DotLab, a medical diagnostics company, announced top-tier pharmaceutical research clients for its DotEndo platform. The customers include global companies with interests in diagnosing or monitoring endometriosis on a Research Use Only basis in clinical trial subjects to support the development of new medicines. "We're proud to share the news of our global pharmaceutical partners, which are complementary to our planned, large clinical offering for commercial endometriosis tests based on our technologies," said DotLab's founder, Heather Bowerman. "Our pharma partners conducted rigorous diligence of our science and intellectual property prior to the execution of our contracts, and they view our platform as the first of its kind and the leader in this space." The DotEndo™ platform's AI/ML technology was developed via DotLab's EMPOWER clinical trial, a prospective, observational, multi-center study run at endometriosis centers of excellence across the United States. EMPOWER is the most robust clinical study of its type ever performed for diagnosing and monitoring endometriosis, making it an excellent foundation for the platform. Based on these successes, DotLab announced Morgan Stanley as a new investor in late 2023. "We intend to continue to offer our pharma clients – and, ultimately, clinicians – a comprehensive endometriosis menu of tests and tools. Endometriosis is notorious for its complex biology, and there has long been a need for tests and tools to diagnose and monitor endometriosis – and ultimately, to improve endpoints for the disease in therapeutic trials," said Bowerman. About DotLab Dot Laboratories, Inc. ("DotLab") is solving some of the world's most significant diagnostic challenges via the latest advancements in multiomics and computational biology. The company delivers clinical innovations to areas of significant unmet need via novel, cutting-edge biomarkers and the power of machine learning to deliver non-invasive tests. The company has driven a paradigm shift in the identification and management of endometriosis. DotLab is female-founded and female-led.

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PHARMA TECH

Frontage Laboratories Acquires Accelera S.r.l.'s Bioanalytical and DMPK Businesses

PR Newswire | January 03, 2024

Frontage Laboratories, Inc. today announced that, through its wholly-owned subsidiary Frontage Europe S.r.l., it has completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (Accelera). Accelera is a premier Contract Research Organization located in Nerviano, within the Lombardy region of Italy, part of the well-established NMS Group S.p.A. which has positioned itself as a global niche player in delivering discovery & preclinical studies and clinical bioanalysis to pharma and biotechnology companies, academic institutions, and other healthcare stakeholders. "Today marks a very significant achievement in the 23-year history of Frontage Laboratories, as we establish a base of operations in continental Europe. Accelera has developed a tremendous reputation for high quality R&D services and we look forward to welcoming their Bioanalytical and Drug Metabolism & Pharmacokinetics teams to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "We envision this strategic acquisition as a first step in establishing Frontage's footprint in Europe, with the intent of adding other service areas in the continent. We believe both existing Frontage and Accelera clients stand to benefit greatly by leveraging Frontage's increasingly global platform. In addition, we are looking forward to partnering with the remaining Accelera business on exciting opportunities to service clients across our organizations." According to Dr. Song Li, Founder and Chairman of Frontage: "It has been a long-standing goal of Frontage to expand our operations in Europe. We consider ourselves fortunate to capitalize on our outstanding relationship with the Accelera team, which has enabled us to bring our plans to fruition. We are very enthusiastic about working together as we further develop the Frontage platform in Europe, starting from a footprint in the Biopark in Nerviano Lombardy, where Accelera and Nerviano Medical Sciences Srl have already established a long-standing and efficient value chain. As always, our ongoing focus will remain on delivering the highest levels of quality, technology and expertise to our clients." "We are thrilled to join forces with Frontage as part of this strategic acquisition that marks a significant milestone in Accelera's journey," said Luca Leone, CEO of Accelera. "Accelera has built a strong reputation for delivering high-quality R&D services through all phases of drug research and development with extensive experience in oncology. This unique occasion opens up new horizons for collaboration and growth. On one hand, we will further focus on offering top-notch In-vivo (end-to-end services) for multiple emerging modalities. At the same time, we look forward to exploring exciting opportunities to serve our clients across continents through our ongoing collaboration. This partnership reflects our commitment to advancing research and providing innovative solutions in the European market and beyond," said Luca Leone, CEO of Accelera S.r.l. "Having Frontage as part of the growing partners operating from our Biopark is a landmark moment for us. In addition to the endless potential of the Accelera-Frontage collaboration, Nerviano Medical Sciences can leverage Frontage's world-class capabilities to drive breakthrough advancements in our drug discovery and development process. By uniting our strengths, we believe we can accelerate the pace of innovation and make a lasting difference in the field where all companies of this strong alliance operate and thrive here in Nerviano," said Hugues Dolgos, CEO of NMS Group S.p.A and Nerviano Medical Sciences Srl. About Frontage Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. About NMS Group NMS Group is the largest oncological R&D company in Italy with more than 400 employees, of whom more than half are highly educated individuals dedicated to innovative research, development and manufacturing. The NMS kinase inhibitor discovery platform as well as the antibody-conjugating payload platform are the driving forces of the group's innovation, securing global recognition of NMS in personalized therapy. Recently entrectinib, originally discovered by NMS, which is a targeted kinase inhibitor used to treat NTRK1/2/3 and ROS1 dependent solid tumors that was licensed to Ignyta, now a member of the Roche Group, gained approvals for commercialization in all major markets. This is further evidence of the competitiveness of the drug discovery platform of NMS Group. NMS Group has three subsidiaries. NMS S.r.l. is a FIC / BIC focused drug research and development company with a robust pipeline of more than a dozen anti-cancer projects, and three of the projects are currently in early clinical development.

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PHARMA TECH

IDBS announces data management partnership with PharmaEssentia Innovation Research Center

PR Newswire | January 24, 2024

IDBS announced today that it has entered into a partnership with Massachusetts-based PharmaEssentia Innovation Research Center (PIRC) on its Polar platform to help digitize data management and facilitate collaboration between the company's global research and development (R&D) teams. The Polar platform will provide PIRC, the newly established U.S. hub of PharmaEssentia's R&D efforts, the ability to electronically collaborate with its team headquartered in Taipei, Taiwan, who have traditionally recorded experimental data on paper. "The IDBS Polar platform provides superior functionality beyond traditional Electronic Laboratory Notebook (ELN) offerings, backed up by our broad customer base and customer support, as well as the ability to support languages like Mandarin," said Pietro Forgione, General Manager at IDBS. "We are proud to help PIRC better capture, structure and interrogate their key data from a single source of truth, thereby making their collaboration more efficient." "We are looking forward to partnering with IDBS, not only to implement the Polar platform to help us manage our data more efficiently and to more seamlessly collaborate with our R&D team in Taipei, but also to work together to further explore ways to bring our innovative therapeutics to market faster," said Lih-Ling Lin, Ph.D., PIRC Founder and Chief Scientific Officer, PharmaEssentia. About IDBS IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of the next generation of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today's most complex challenges. Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and IDBS PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain.

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