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biopharmaceutical

JAPAC Drug Development: Navigating Safety & Regulatory Requirements

by Dr. Jayawant Fuke, Senior Director of Lifecycle Safety, IQVI & Hye Jin Choi, R. Ph., Sr. Director of Regulatory Affairs and Drug Development Solutions, IQVIA Asia Pacific 04/15/2024 Leave a Comment

Navigating Safety and Regulatory for JAPAC: Distinctions and Challenges

The biopharmaceutical market within the Japan and Asia-Pacific (JAPAC) region has grown consistently since 2010, specifically for emerging biopharmas (EBPs). In fact, in 2018, 80% of all biopharma pipeline projects in JAPAC were EBPs, accounting for 75% of the total clinical trial volume in the region. This growth benefits contract research organizations, pharma organizations and patients alike, but several factors must be considered for drug development safety and regulatory operations in JAPAC
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Can Technology Live Up to Its Promise for Clinical Trials?

by Stephen Pyke, Chief Clinical Digital and Data Officer, Parexel 04/04/2023 Leave a Comment

Can Technology Live Up to Its Promise for Clinical Trials?

By creating efficiencies with technology, CROs have an opportunity to build clinical trials of the future. For many years, artificial intelligence (AI), machine learning (ML) and natural language processing (NLP) had a reputation in the biopharmaceutical industry as flashy buzzwords, with little concrete evidence to back up their promise. Over time, this lack of understanding has created drawn-out anticipation, leaving many skeptical about the true value of these tools.  As the
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Sanofi to Acquire Diabetes Therapy Maker Provention Bio for $2.9B

by Fred Pennic 03/13/2023 Leave a Comment

Sanofi to Acquire Diabetes Therapy Maker Provention Bio for $2.9B

What You Should Know: - Sanofi has agreed to acquire Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), for $25.00 per share in cash, representing an equity value of approximately $2.9B. - The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet
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Report: Pharma R&D ROI Falls to Lowest Level in 13 Years

by Syed Hamza Sohail 02/16/2023 Leave a Comment

Pharma R&D ROI Falls to Lowest Level in 13 Years

What You Should Know: - Deloitte Centre for Health Solutions releases its thirteenth annual report, ‘Seize the Digital Momentum: Measuring the return from pharmaceutical innovation 2022’ that explores the performance of the biopharmaceutical industry (bio Pharma) and its ability to generate returns from investment in innovative new medicines. - Since 2021, much of the world has successfully adjusted to life where COVID-19 is more endemic as vaccines and treatments reduced the risk and
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High Inflation is Driving The Deferment of Necessary Medical Care

by Paul Ketchel, CEO of MDsave 01/23/2023 Leave a Comment

High Inflation is Driving the Deferment of Necessary Medical Care

Inflation continues to be a burden – food, gas, holiday spending, new year’s goals This past year has been especially challenging as inflation costs continue to touch all aspects of daily life, leading to tough choices for many consumers as we finished the holiday season and look to goals and planning for 2023. In fact, two out of five (40%) survey respondents said inflation changed the way they shopped for the holidays.  As consumers adjust their spending habits, many are finding
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Caris Life Sciences and ConcertAI Partner to Accelerate Drug Development and Novel Research

by Jasmine Pennic 01/09/2023 Leave a Comment

Caris Life Sciences and ConcertAI Partner to Accelerate Drug Development and Novel Research

What You Should Know: - Caris Life Sciences®(Caris), a molecular science, artificial intelligence (AI) and machine learning technology company actively developing and delivering innovative solutions to revolutionize healthcare, and ConcertAI, an oncology real-world evidence data and AI technology company, announced a unique partnership to align the two companies' oncology capabilities. - The strategic partnership will create one of the largest translational and clinical
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Biomica Raises $20M to Advance its Pipeline of Microbiome-based Therapeutics

by Jasmine Pennic 12/21/2022 Leave a Comment

Biomica Raises $20M to Advance its Pipeline of Microbiome-based Therapeutics

What You Should Know: - Biomica, a clinical-stage biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd raises $20M led by Shanghai Healthcare Capital (SHC). - The financing round will enable Biomica to forge ahead, developing its pipeline of microbiome-based therapeutics. Biomica plans to use the proceeds to complete its current BMC128 phase 1 immuno-oncology study and advance to phase 2 clinical trial; scale up and complete GMP
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Merck Invests in Gesund, Launches Medical AI Platform on AWS

by Syed Hamza Sohail 12/21/2022 Leave a Comment

Merck Invests in Gesund, Launches Medical AI Platform on AWS

What You Should Know: - Gesund, the company ensuring that medical artificial intelligence (AI) is safe and effective for all, today announced the securing of a strategic investment from Merck as well as a launch of a new commercial platform on Amazon Web Services Marketplace. - While terms of the investment are not being disclosed, the news signals support for the company's approach as it launches a first of its kind commercial platform on Amazon Web Services Marketplace, immediately
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BrightInsight Adds Xealth, Woebot Health and Claritas Rx to the BrightInsight Ecosystem

by Syed Hamza Sohail 09/28/2022 Leave a Comment

BrightInsight Adds Xealth, Woebot Health and Claritas Rx to the BrightInsight Ecosystem

- BrightInsight, Inc., a global platform for biopharma and medtech regulated digital health solutions, recently announced the expansion of its recently launched BrightInsight Ecosystem, a network of the world’s leading healthcare and technology companies collaborating to solve healthcare’s biggest challenges to drive digital innovation, adoption and engagement. - In addition, BrightInsight is proud to be a part of General Catalyst’s Health Assurance network—comprised of healthcare technology
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Elevation Oncology Secures $50M Loan Facility with K2 HealthVentures

by Jasmine Pennic 07/28/2022 Leave a Comment

Elevation Oncology Secures $50M Loan Facility with K2 HealthVentures

What You Should Know: Elevation Oncology, a clinical-stage biopharmaceutical company focused on the development of precision oncology products for patients with genomically defined cancers, today announced that it has secured a $50M senior secured loan facility from funds managed by K2 HealthVentures. Elevation plans to use the funding from the facility will primarily support the exclusive license of EO-3021 (SYSA1801) outside of Greater China from CSPC Pharmaceutical Group and the
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