Pharmaceutical Technology
APRIL 19, 2024
The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).
Bio Pharma Dive
APRIL 19, 2024
The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
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Pharmaceutical Technology
APRIL 19, 2024
The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).
Bio Pharma Dive
APRIL 19, 2024
The agreement may help Alvotech capitalize on a recent policy shift by CVS that has driven major market share declines for AbbVie’s blockbuster drug.
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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
Pharmaceutical Technology
APRIL 19, 2024
Researchers at the National Cancer Institute, a unit of the National Institutes of Health (NIH) in the US, have developed an AI tool that can predict drug responses in cancer treatment.
pharmaphorum
APRIL 19, 2024
Roche's Alecenesa has become the first ALK inhibitor to be approved by the FDA for adjuvant use in early-stage, ALK+ NSCLC
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
APRIL 19, 2024
Cerevel's first phase 3 trial of Parkinson's drug tavapadon is positive - good news for AbbVie which is trying to buy the biotech for $8.
Pharmaceutical Technology
APRIL 19, 2024
Following the success of the COVID-19 vaccines, there has been an increasing focus on mRNA’s potential to address a wide range of diseases, including cancer.
Fierce Pharma
APRIL 19, 2024
This week on “The Top Line,” we're joined by Fierce Biotech Senior Editor Annalee Armstrong and Fierce Pharma Marketing Senior Editor Ben Adams. | This week on "The Top Line," we are joined by Annalee Armstrong, Senior Editor at Fierce Biotech, and Ben Adams, Senior Editor of Fierce Pharma Marketing, to discuss Fierce's take on March Madness.
Pharmaceutical Technology
APRIL 19, 2024
Rhenium (186Re) obisbemeda is under clinical development by Plus Therapeutics and currently in Phase II for Head And Neck Cancer.
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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
Pharma Times
APRIL 19, 2024
Both will develop cancer vaccine candidates in selected haematological and solid tumour indications
Pharmaceutical Technology
APRIL 19, 2024
Pharmaceutical Technology Has Listed Some of the Leading Providers of Clinical Trial Packaging Services. Download For Free Here.
Fierce Pharma
APRIL 19, 2024
Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little | Nearly a year and a half after FibroGen slapped a pair of former employees with a lawsuit alleging trade secrets theft, both the plaintiffs and the defendants are walking away from the case little worse for wear.
Pharmaceutical Technology
APRIL 19, 2024
Evotec has entered a partnership agreement with Variant Bio aimed at detecting a treatment for ailments caused by fibrosis.
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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.
Fierce Pharma
APRIL 19, 2024
Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. | Roche isn’t content with Alecensa being the best-selling ALK inhibitor in metastatic lung cancer. The Swiss pharma has now secured an FDA approval in the post-surgical setting as it continues to test the drug in additional patient populations.
Pharmaceutical Technology
APRIL 19, 2024
Pharmaceutical Compliance Management Software Is Designed to Enhance Patient Safety. Download the Free Buyer’s Guide Here.
Outsourcing Pharma
APRIL 19, 2024
Earlier this week, Charles River Laboratories International, Inc. revealed its Alternative Methods Advancement Project (AMAP), which it said is a strong initiative aimed at changing drug discovery and development by exploring alternatives to animal testing.
Pharmaceutical Technology
APRIL 19, 2024
The long-term agreement will see increased access of Simlandi, a biosimilar to AbbVie’s Humira, in the US market.
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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.
Pharma Times
APRIL 19, 2024
Involving 152 patients, the SENTINEL trial aims to cut lung transplant rejection by up to 50%
Pharmaceutical Technology
APRIL 19, 2024
SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Non-Small Cell Lung Cancer.
Pharmaceutical Commerce
APRIL 19, 2024
The latest news for pharma industry insiders.
Pharmaceutical Technology
APRIL 19, 2024
SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Breast Cancer.
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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.
pharmaphorum
APRIL 19, 2024
Stay updated on the latest STEM Healthcare news from Reuters Pharma USA 2024, featuring insights from global account lead at STEM, Serena Goodwin on the impact of AI in healthcare.
Pharmaceutical Technology
APRIL 19, 2024
JS-006 is under clinical development by Shanghai Junshi Biosciences and currently in Phase II for Non-Small Cell Lung Cancer.
Pharmaceutical Commerce
APRIL 19, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Niklas Adamsson, COO, Environtainer, suggests how to improve visibility and risk management for cold chain shipping.
Pharmaceutical Technology
APRIL 19, 2024
JS-006 is under clinical development by Shanghai Junshi Biosciences and currently in Phase II for Hepatocellular Carcinoma.
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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.
Outsourcing Pharma
APRIL 19, 2024
LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.
Pharmaceutical Technology
APRIL 19, 2024
SGN-1 is under clinical development by Guangzhou Huajin Pharmaceutical Technology and currently in Phase II for Sarcomas.
Crucial Data Soutions
APRIL 19, 2024
The landscape of clinical research is undergoing a rapid digital transformation. Data can be collected in ways not imagined just. The post Build Better Studies Faster: 3 Advantages of Mobile eClinical Platforms appeared first on Crucial Data Solutions.
Pharmaceutical Technology
APRIL 19, 2024
XH-001 is under clinical development by NeoCura Bio-Medical Technology and currently in Phase II for Solid Tumor.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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