Mon.Dec 30, 2024

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Digital biomarkers: Redefining respiratory care

pharmaphorum

Learn how digital biomarkers are revolutionising respiratory care by providing personalised, real-time data for better monitoring and management of respiratory diseases.

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MTX-COVAB by Memo Therapeutics for Coronavirus Disease 2019 (COVID-19): Likelihood of Approval

Pharmaceutical Technology

MTX-COVAB is under clinical development by Memo Therapeutics and currently in Phase I for Coronavirus Disease 2019 (COVID-19).

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Opdivo's subcutaneous PD-1 inhibitor cleared in US

pharmaphorum

BMS beats MSD to the US subcutaneous PD-1 inhibitor market after Opdivo Qvantiq is cleared across nearly all the indications of the IV form

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FDA approves BMS’ Opdivo Qvantig for solid tumour indications

Pharmaceutical Technology

The US FDA has granted approval for Bristol Myers Squibbs (BMS) Opdivo Qvantig for subcutaneous use to treat various solid tumours.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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First global approval for Daiichi Sankyo's Dato-DXd

pharmaphorum

Daiichi Sankyo has claimed its first approval, in Japan, for TROP2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan

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BeiGene’s Tevimbra approved in US for first-line gastric cancer treatment

Pharmaceutical Technology

Tevimbra is already approved in the US for the treatment of unresectable or metastatic oesophageal squamous cell carcinoma (ESCC).

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ITM-91 by ITM Isotope Technologies Munich for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

ITM-91 is under clinical development by ITM Isotope Technologies Munich and currently in Phase II for Pancreatic Ductal Adenocarcinoma.

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market.

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ITM-91 by ITM Isotope Technologies Munich for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

ITM-91 is under clinical development by ITM Isotope Technologies Munich and currently in Phase II for Metastatic Colorectal Cancer.

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Cenerimod Reduces SLE Disease Activity, Paves the Way for Phase III

XTalks

Viatris Inc. has announced promising Phase IIb results for cenerimod, an investigational drug targeting immune system dysfunction in moderate-to-severe systemic lupus erythematosus (SLE). SLE is an autoimmune disease where the immune system attacks healthy tissues, causing inflammation, pain and potential organ damage. Cenerimod modulates the immune response, reducing inflammation and preventing the production of harmful autoantibodies.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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CT-7439 by Carrick Therapeutics for Breast Cancer: Likelihood of Approval

Pharmaceutical Technology

CT-7439 is under clinical development by Carrick Therapeutics and currently in Phase I for Breast Cancer.

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Fierce Biotech Article: Paul Evans on Clinical Trials in 2025

Velocity Clinical Research

A new Fierce Biotech article features insights from Paul Evans on what to expect for clinical research in 2025. Topics include rising costs and uncertain regulations, as well as the continued emergence of site networks, AI-driven efficiency (with technology built by trial sites, for trial sites), and enhanced diversity initiatives. Read the article here: [link] The post Fierce Biotech Article: Paul Evans on Clinical Trials in 2025 appeared first on Velocity Clinical Research.

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Iptacopan hydrochloride by Novartis for Granulomatosis with Polyangiitis (Wegener’s Granulomatosis): Likelihood of Approval

Pharmaceutical Technology

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase II for Granulomatosis with Polyangiitis (Wegener's Granulomatosis).

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Pharma Commerce’s Most Popular Patient Support Articles

Pharmaceutical Commerce

A dive into the top articles in this sector making waves this year.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Tevimbra by BeiGene for Gallbladder Cancer: Likelihood of Approval

Pharmaceutical Technology

Tevimbra is under clinical development by BeiGene and currently in Phase II for Gallbladder Cancer.

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Newly Identified Molecule Can Heal Gut Damage And Suppress Cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

(Meeko Media/iStock/Getty Images Plus) Intestines suffer a lot of wear and tear in their daily service to digestion, requiring constant renewal of their lining. This growth of the gut’s wall hints at underlying pathways distinguishing beneficial regeneration from the rampant reproduction of a tumor.

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Tevimbra by BeiGene for Muscle Invasive Bladder Cancer (MIBC): Likelihood of Approval

Pharmaceutical Technology

Tevimbra is under clinical development by BeiGene and currently in Phase II for Muscle Invasive Bladder Cancer (MIBC).

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Best Pharmacist Award 2024 of TN IPA bestowed on K Pandiyan of Saimirra Innopharm

AuroBlog - Aurous Healthcare Clinical Trials blog

K Pandiyan , general manager of the Chennai based drug manufacturing company, Saimirra Innopharm Pvt Ltd, has been bestowed with the prestigious Best Pharmacist Award 2024 instituted by the Tamil Nadu branch of the Indian Pharmaceutical Association.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NVP-1805R2 by NVP Healthcare for Unspecified Cardiovascular Disorders: Likelihood of Approval

Pharmaceutical Technology

NVP-1805R2 is under clinical development by NVP Healthcare and currently in Phase I for Unspecified Cardiovascular Disorders.

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New Insights into Quality Assurance Jobs: Impact, Growth and Opportunities

XTalks

Quality assurance (QA) plays a vital role across industries like life sciences, food, medical devices and healthcare. QA ensures that products, systems and processes meet stringent standards for safety, efficacy and compliance, safeguarding consumers and elevating industry standards. From life-saving drugs to ensuring the food we consume is safe, QAs impact is far-reaching.

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Xaluritamig by Amgen for Prostate Cancer: Likelihood of Approval

Pharmaceutical Technology

Xaluritamig is under clinical development by Amgen and currently in Phase I for Prostate Cancer.

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LXE-408 by Novartis for Chagas Disease (American Trypanosomiasis): Likelihood of Approval

Pharmaceutical Technology

LXE-408 is under clinical development by Novartis and currently in Phase I for Chagas Disease (American Trypanosomiasis).

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Tebapivat by Agios Pharmaceuticals for Sickle Cell Disease: Likelihood of Approval

Pharmaceutical Technology

Tebapivat is under clinical development by Agios Pharmaceuticals and currently in Phase I for Sickle Cell Disease.

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ITM-91 by ITM Isotope Technologies Munich for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

ITM-91 is under clinical development by ITM Isotope Technologies Munich and currently in Phase II for Pancreatic Ductal Adenocarcinoma.

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ITM-91 by ITM Isotope Technologies Munich for Metastatic Colorectal Cancer: Likelihood of Approval

Pharmaceutical Technology

ITM-91 is under clinical development by ITM Isotope Technologies Munich and currently in Phase II for Metastatic Colorectal Cancer.

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CT-7439 by Carrick Therapeutics for Breast Cancer: Likelihood of Approval

Pharmaceutical Technology

CT-7439 is under clinical development by Carrick Therapeutics and currently in Phase I for Breast Cancer.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Iptacopan hydrochloride by Novartis for Granulomatosis with Polyangiitis (Wegener’s Granulomatosis): Likelihood of Approval

Pharmaceutical Technology

Iptacopan hydrochloride is under clinical development by Novartis and currently in Phase II for Granulomatosis with Polyangiitis (Wegener's Granulomatosis).

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Tevimbra by BeiGene for Gallbladder Cancer: Likelihood of Approval

Pharmaceutical Technology

Tevimbra is under clinical development by BeiGene and currently in Phase II for Gallbladder Cancer.

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Tevimbra by BeiGene for Muscle Invasive Bladder Cancer (MIBC): Likelihood of Approval

Pharmaceutical Technology

Tevimbra is under clinical development by BeiGene and currently in Phase II for Muscle Invasive Bladder Cancer (MIBC).

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NVP-1805R2 by NVP Healthcare for Unspecified Cardiovascular Disorders: Likelihood of Approval

Pharmaceutical Technology

NVP-1805R2 is under clinical development by NVP Healthcare and currently in Phase I for Unspecified Cardiovascular Disorders.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.