Bio Pharma Dive
FEBRUARY 20, 2024
The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes.
Pharmaceutical Technology
FEBRUARY 20, 2024
Xolair is the first FDA-approved drug to reduce allergic reactions in people with one or more food allergies, as per Roche’s announcement.
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AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 20, 2024
The Indian Institute of Science (IISc) and Blockchain For Impact (BFI) have teamed up to maximise translational research projects where the latter aims to allocate US$1 million. The collaboration, under the BFI-Biome Virtual Network Programme, will see BFI to support various research projects at the IISc.
Bio Pharma Dive
FEBRUARY 20, 2024
Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 20, 2024
Neuroscientists have ‘hacked’ the brain’s memory pathways with a new prosthetic system that could help improve the recollection of specific memories.
Bio Pharma Dive
FEBRUARY 20, 2024
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 20, 2024
A “second request” from the Federal Trade Commission could protract the timing of AbbVie’s proposed acquisition, which is slated to close around the middle of the year.
Pharmaceutical Technology
FEBRUARY 20, 2024
The US FDA has accepted for priority review argenx's sBLA for VYVGART Hytrulo to treat chronic inflammatory demyelinating polyneuropathy.
Bio Pharma Dive
FEBRUARY 20, 2024
Can asynchronous advisory programs can add distinct value to your strategic mix? Yes! Here's how.
Pharmaceutical Technology
FEBRUARY 20, 2024
The Singapore HSA has accepted the new drug application (NDA) for AffaMed Therapeutics’ DEXTENZA to treat ocular inflammation and pain.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
FEBRUARY 20, 2024
The veteran executive, who guided AbbVie through its separation from Abbott Laboratories, will be succeeded by Chief Operating Officer Robert Michael.
Pharmaceutical Technology
FEBRUARY 20, 2024
Pfizer has obtained marketing authorisation from the European Commission (EC) for VELSIPITY to treat ulcerative colitis (UC).
Bio Pharma Dive
FEBRUARY 20, 2024
The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.
Pharmaceutical Technology
FEBRUARY 20, 2024
AstraZeneca has concluded the acquisition of clinical-stage biopharmaceutical company Icosavax in a $1.1bn deal.
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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
Rethinking Clinical Trials
FEBRUARY 20, 2024
Speaker Jeffrey Carson, MD, MACP Principal Investigator and Study Chair MINT Trial Provost-New Brunswick, Rutgers Biomedical Health Sciences Distinguished Professor of Medicine Richard C. Reynolds, M.D. Chair in General Internal Medicine Rutgers, Robert Wood Johnson Medical School Keywords Transfusion; MI; MINT; Anemia; Clinical trials Key Points Anemia is common in patients with acute MI.
Pharmaceutical Technology
FEBRUARY 20, 2024
We explore the challenges when conducting analytical testing of the popular preservative Benzalkonium Chloride.
pharmaphorum
FEBRUARY 20, 2024
The FDA has said it plans to deliver a decision in June on the use of Argenx’ Vyvgart Hytrulo in rare autoimmune disease chronic inflammatory demyelinating polyneuropathy (CIDP).
Pharmaceutical Technology
FEBRUARY 20, 2024
CX-2029 is under clinical development by CytomX Therapeutics and currently in Phase II for Pancreatic Cancer.
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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.
BioPharma Reporter
FEBRUARY 20, 2024
Novo Nordisk recently acquired three manufacturing facilities from contract development and manufacturing organization Catalent, in a bold move that has sparked a great deal of debate and some backlash.
Pharmaceutical Technology
FEBRUARY 20, 2024
Not Disclosed Neurodegeneration is under clinical development by Eli Lilly and Co and currently in Phase I for Neurodegenerative Diseases.
pharmaphorum
FEBRUARY 20, 2024
The European Commission has approved Pfizer’s S1P receptor modulator Velsipity as a treatment for ulcerative colitis (UC), raising the pressure on Bristol-Myers Squibb’s first-to-market Zeposia.
Pharmaceutical Technology
FEBRUARY 20, 2024
ST101 is under clinical development by Sapience Therapeutics and currently in Phase II for Signet Ring Cell Squamous Cell Carcinoma.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Commerce
FEBRUARY 20, 2024
The agency will make its final decision surrounding the locally advanced or metastatic nonsquamous NSCLC drug —based on results from the TROPION-Lung01 Phase III trial—by Q4 2024.
Pharmaceutical Technology
FEBRUARY 20, 2024
ST101 is under clinical development by Sapience Therapeutics and currently in Phase II for Recurrent Glioblastoma Multiforme (GBM).
Fierce Pharma
FEBRUARY 20, 2024
After laying out plans to absorb a pair of production subsidiaries in October, Japan’s Daiichi Sankyo is doubling down on its quest to dominate the red-hot antibody-drug conjugate (ADC) field. | Aiming to beef up development and manufacturing of antibody-drug conjugates, Daiichi Sankyo is plugging roughly €1 billion ($1.08 billion) into an expansion of its production facility in Pfaffenhofen an der Ilm, Germany.
Pharmaceutical Technology
FEBRUARY 20, 2024
Ketamine is under clinical development by NRX Pharmaceuticals and currently in Phase III for Bipolar Disorder (Manic Depression).
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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.
Fierce Pharma
FEBRUARY 20, 2024
AstraZeneca, having surpassed its long-term $45 billion revenue goal last year, has handsomely rewarded its chief executive. | AstraZeneca CEO Pascal Soriot’s compensation package makes him the current top contender for 2023’s highest-paid pharma CEO in Europe. Still, as in years past, not everyone is pleased with Soriot’s 2023 windfall.
Pharmaceutical Technology
FEBRUARY 20, 2024
CX-2029 is under clinical development by CytomX Therapeutics and currently in Phase II for Kidney Cancer (Renal Cell Cancer).
ProRelix Research
FEBRUARY 20, 2024
Crafting impactful oncology clinical trial protocols requires a strategic approach to ensure rigorous research, patient safety, and meaningful outcomes. Explore key considerations and best practices for designing effective protocols in […] The post Designing Effective Oncology Clinical Trial Protocols appeared first on ProRelix Research.
Pharmaceutical Technology
FEBRUARY 20, 2024
CX-2029 is under clinical development by CytomX Therapeutics and currently in Phase II for Thymoma (Thymic Epithelial Tumor).
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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