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Making the Most of Real-World Data in Clinical Trials

Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
- Source: drugdu
- 177
- January 3, 2024
A Monthly Summary of Hires and Layoffs

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry. By KATIE ADAMS This roundup will be published monthly. It is meant to highlight some of healthcare’s recent hiring news and is not intended to be comprehensive. If you have news about an executive appointment, resignation or layoff that you would like to share for this roundup or the MedCity Moves podcast, please reach out to moves@medcitynews.com. Here is a selection of recent executive hires, promotions, departures and layoffs occurring across the healthcare industry. Hires Aledade, an independent primary care network focused on value-based care, brought Rosemary Weldon onto its team as its new chief product officer. She spent the last decade at CVS Health, where she most recently served as vice president of digital health product management. Amgen welcomed James Bradner to its C-suite, where he now serves as chief scientific officer and ...
- Source: drugdu
- 232
- January 3, 2024
US judge allows FTC to temporarily block IQVIA acquisition of DeepIntent

(Reuters) – A U.S. court on Friday upheld a Federal Trade Commission (FTC) order to block IQVIA’s acquisition of DeepIntent, a healthcare advertising firm, as it may harm competition. DeepIntent, owned by Propel Media, a digital media and advertising company, entered into an agreement with U.S. headquartered IQVIA in 2022 with the intent to facilitate seamless communication between patients and healthcare providers. Earlier this year, the FTC intervened to block IQVIA and DeepIntent’s proposed merger so as to prevent increased concentration in health care programmatic advertising. The merger would harm competition and would lead to increased prices for consumers, and hurt patients, FTC had said. DeepIntent’s chief executive officer previously in an open letter said that the company would walk away from the deal and would remain an independent company had the regulator won the block. The financial terms of the deal are not known. Speaking in favor of the ...
- Source: drugdu
- 173
- January 3, 2024
Innovent Dosed First Participant in Phase 3 Clinical Study (GLORY-2) of Mazdutide (IBI362) Higher Dose 9 mg in Chinese Adults with Obesity

ROCKVILLE, U.S. and SUZHOU, China, Jan 2, 2024 — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed in a Phase 3 clinical trial (GLORY-2) of higher dose 9 mg mazdutide (Innovent R&D Code: IBI362) , a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with obesity. This is also the fourth large-scale phase 3 clinical study of mazdutide.GLORY-2 plans to enroll 450 subjects and randomize to receive mazdutide 9 mg treatment or placebo. The primary endpoints include the percentage change in body weight from baseline to week 60 and the proportion of subjects with 5% or more body weight loss from baseline at week 60.A Phase 2 study conducted in Chinese people with obesity ...
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- 159
- January 3, 2024
CD3/BCMA/GPRC5D Tri-Specific Antibody MBS314 Approved in Phase I/II Clinical Trial for the Treatment of Multiple Myeloma

Recently, MBS314, an innovative tri-specific antibody product developed by Beijing Mabworks Biotech Company Limited (hereinafter referred to as “Mabworks”) in collaboration with Kangyuan Botron Biotechnology (Beijing) Limited, has obtained the Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration of the People’s Republic of China (SDA), which authorizes the conduct of Phase I/II clinical trial for the treatment of multiple myeloma. Myeloma. MBS314 is a new mechanism of tri-specific antibody targeting CD3/BCMA/GPRC5D for the treatment of multiple myeloma.MBS314 has a differentiated CD3 binding epitope, which is able to achieve low-affinity but long-lasting activation and killing effect with T-cells, with better safety; at the same time, it binds BCMA and GPRC5D with high affinity, which is able to overcome BCMA and GPRC5D tumor cell killing effect in the body of the patient. At the same time, the high affinity combination of BCMA and GPRC5D can overcome ...
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- 149
- January 3, 2024
SINOPHARM Releases 2022 Environment, Social and Governance Report

The Environment, Social and Governance Report 2022 is the first ESG report released by SINOPHARM. The report focuses on the three themes of “Sinopharm – Navigating New High-Quality Development”, “Green Sinopharm – Building a Green and Safe Home” and “Warm Sinopharm – Guarding the People’s Good Life”, and comprehensively demonstrates the economic, social and governance achievements of Sinopharm in 2022. SINOPHARM’s comprehensive economic, social and environmental values in 2022 were comprehensively demonstrated, and SINOPHARM, as the national team and main force of the central pharmaceutical enterprises, was strongly demonstrated through the two responsibility themes of “Comprehensively Deepening Reform” and “Empowering Rural Revitalization” and the performance of the sustainable development (SDG) actions. As the national team, main force and pillar of the central pharmaceutical enterprise, Sinopharm actively serves the national strategy, improves its core competitiveness, enhances its core functions, and contributes Sinopharm’s power and wisdom to build a safe, green, harmonious ...
- Source: drugdu
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- January 3, 2024
Regeneron fends off Viatris’ Eylea biosimilar with patent win

Armed with a new victory over Viatris in a patent dispute, Regeneron can knock off one contender in the Eylea biosimilar race. A West Virginia judge ruled that Viatris’ proposed biosimilar violates a Regeneron patent that covers ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist suitable for intravitreal administration to the eye. That patent is expected to expire in June 2027. Viatris, a generic and biosimilar specialist created by Pfizer through the combination of its Upjohn business with Mylan back in 2020, was the first to file for a coveted Eylea biosimilar in 2021. Regeneron struck back with its suit in 2022, arguing that the proposed copycat steps on 24 of its patents. The complaint was later trimmed to three, according to Bloomberg. Viatris has since offloaded its biosimilars unit to Biocon Biologics in a $3.33 billion cash-and-stock deal. Amgen tried to get into the litigation ...
- Source: drugdu
- 166
- January 3, 2024
‘Disappointed’ IQVIA hit by judge’s decision to uphold FTC’s block of its DeepIntent buyout

A U.S. judge has upheld the Federal Trade Commission’s (FTC) decision to block IQVIA’s long-running attempt to buy the owner of pharma digital ad specialist DeepIntent. The long-running saga centers on IQVIA, the leading biopharma data provider, and its attempt to snap up Propel Media for its DeepIntent business. IQVIA tried to buy Propel back in 2022 (financials details remain unknown), but the FTC last year put a block on the deal, arguing that it would inevitably give IQVIA a market-leading position in advertising for healthcare products, namely prescription drugs, to doctors and other healthcare professionals. According to the official complaint filed by the FTC in 2023, the merger would result in a “heightened motivation” for IQVIA to withhold critical information, hindering competition among rival companies and potential new entrants. Additionally, the complaint asserts that the merger would lead to decreased market competitiveness. The company is one of the world’s ...
- Source: drugdu
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- January 3, 2024
FDA clears neurovascular aspiration, access catheters from Perfuze

BY SEAN WHOOLEY The Millipede catheter. [Image courtesy of Perfuze] Perfuze announced today that the FDA cleared its Millipede 070 aspiration catheter and second-generation Millipede 088 access catheter. Galway, Ireland-based Perfuze developed Millipede 070 to address critical unmet needs in ischemic stroke treatment. It aims to remove clots rapidly and safely through a novel, unique catheter. Millipede 070 has a unique design with a rib-and-recess surface architecture to improve navigability and reduce tip stiffness while maintaining durability. The design features superior deliverability and high procedural efficiency, enabling a more refined approach for restoring blood flow to the brain during endovascular thrombectomy procedures. The company currently has enrollment underway for its MARRS pivotal clinical study to support future regulatory submissions. “Perfuze aims to provide neurovascular interventionists with innovative thrombectomy solutions, to maximize their opportunity to completely restore blood flow to the brain on their first attempt,” said Wayne Allen, CEO. “The ...
- Source: drugdu
- 176
- January 2, 2024
One VC Firm’s 5 Healthcare Predictions for 2024

Executives at LRVHealth expect to see a continued focus on generative AI, increased enrollment in Medicare Advantage and more in 2024. By MARISSA PLESCIA The healthcare landscape in 2024 presents some interesting challenges and opportunities, whether it’s in regards to generative AI or value-based care, according to executives at LRVHealth, a healthcare venture capital firm. These executives shared five predictions for 2024 with MedCity News: 1. Generative AI will become a reality: Generative AI will become more than “just hopes, dreams and pilot programs” in 2024, according to Keith Figlioli, managing partner at LRVHealth. The healthcare industry will start to actually put AI into practice next year. However, there will be some challenges, as well. 2. “We’ll see at least one event around bias or misuse of generative AI in clinical delivery,” Figlioli said. “Most healthcare companies aren’t applying generative AI to personal health information (PHI), but this event will ...
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- 213
- January 2, 2024

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