Bio Pharma Dive
JUNE 3, 2024
Liquid biopsy has emerged as a revolutionary tool for clinical trials, offering cellular and cell-free methods that provide valuable insights into disease progression and treatment response.
Pharmaceutical Technology
JUNE 3, 2024
Moderna has secured approval from the US Food and Drug Administration (FDA) for mRESVIA (respiratory syncytial virus vaccine).
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Bio Pharma Dive
JUNE 3, 2024
Shares in the company soared by more than 50% as study data showed the pill led to similar levels of weight loss as a rival drug being developed by Eli Lilly.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 3, 2024
Researchers at the Indian Institute of Science (IISc) have found that Pranlukast have the potential applications in tuberculosis (TB) therapy. The researchers are of the view that it could enhance the healing process of lung tissues infected with TB.
Bio Pharma Dive
JUNE 3, 2024
The number of oral cancer medications is increasing, opening new possibilities for improved convenience, but some studies show much lower adherence rates with oral oncolytics.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 3, 2024
Taking blood pressure medication at a time that aligns with your personal chronotype – the way your body’s circadian rhythm affects when you go to sleep and get up – could help to protect the heart against the risk of heart attack, a new study shows.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 3, 2024
The choice of control means that a US or European approval for Ambrx's ARX788 may not be possible based on ACE-Breast-02 study data.
Bio Pharma Dive
JUNE 3, 2024
With new modalities such as gene and cell therapies, RNA therapeutics, complex biologics and more, today’s science brings unprecedented opportunities to address diseases that have long remained out of reach.
Pharmaceutical Technology
JUNE 3, 2024
EMA's CHMP has recommended the approval of CStone's sugemalimab for the first-line treatment of metastatic non-small cell lung cancer.
Bio Pharma Dive
JUNE 3, 2024
AstraZeneca’s targeted therapy could see wider use after ASCO data. Elsewhere, Caribou sought to course correct and Lilly talked up its next cancer drug.
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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
Pharmaceutical Technology
JUNE 3, 2024
QRL-204 is designed to restore UNC13A function, a gene identified as a risk factor in neurodegenerative diseases including ALS and dementia.
pharmaphorum
JUNE 3, 2024
Understanding the challenges and opportunities in transitioning to IVDR for pharmacogenomics can be complex. Learn more about how to overcome these challenges effectively.
Pharmaceutical Technology
JUNE 3, 2024
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Mirum Pharmaceuticals’ LIVMARLI.
Fierce Pharma
JUNE 3, 2024
Following fellow immunotherapy regimens by Roche and AstraZeneca, Bristol Myers Squibb’s Opdivo and Yervoy want to carve out a piece of the first-line liver cancer market, too. | Following fellow immunotherapy regimens by Roche and AstraZeneca, Bristol Myers Squibb’s Opdivo and Yervoy want to carve out a piece of the first-line liver cancer market, too.
Pharmaceutical Technology
JUNE 3, 2024
GRIT has formed a strategic partnership with Quangang Pharmaceutical (Quangang) to enhance research for solid tumour patients in China.
Outsourcing Pharma
JUNE 3, 2024
Mila, an artificial intelligence (AI) research institute based in Montreal, has positioned itself as a global leader in AI and machine learning.
Pharmaceutical Technology
JUNE 3, 2024
An inline density measurement system enables real-time, waste-free granule monitoring suitable for continuous manufacturing lines.
BioPharma Reporter
JUNE 3, 2024
Thousands of patients in England are set to be enrolled into groundbreaking trials for personalized cancer vaccines through an innovative NHS 'matchmaking' initiative aimed at saving lives.
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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.
Pharmaceutical Technology
JUNE 3, 2024
At the ASCO annual meeting, Tagrisso showed an improvement in progression free survival compared to placebo.
Fierce Pharma
JUNE 3, 2024
Thanks to a shortage of the isotope actinium, RayzeBio has temporarily halted new patient enrollment in its phase 3 study in neuroendocrine tumors.
Pharmaceutical Technology
JUNE 3, 2024
The European Commission will now decide whether to grant marketing authorisation in August this year.
XTalks
JUNE 3, 2024
Biocon Biologics’ Yesafili (aflibercept-jbvf) and Biogen and Samsung Bioepis’ jointly developed Opuviz (aflibercept-yszy) have been given the green light by the US Food and Drug Administration (FDA) as the first interchangeable biosimilars to blockbuster eye drug Eylea. Yesafili and Opuviz are approved to treat the same conditions as Regeneron’s vascular endothelial growth factor (VEGF) inhibitor Eylea — neovascular (wet) age-related macular degeneration (AMD), diabetic retinopathy, macular edem
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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
BioPharma Reporter
JUNE 3, 2024
With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu Gadgil shares insights into Enzene's journey, its innovative approach to biosimilars.
Fierce Pharma
JUNE 3, 2024
In the field of anti-CD38 treatment for multiple myeloma, Johnson & Johnson’s Darzalex casts a long shadow. Now, Sanofi hopes a first-in-class win will help its Sarclisa gain an edge. | In the field of anti-CD38 treatment for multiple myeloma, Johnson & Johnson’s Darzalex casts a long shadow. Now, Sanofi hopes a first-in-class win will help its Sarclisa gain an edge.
pharmaphorum
JUNE 3, 2024
The BIOSECURE Act is a proposed legislation that reflects the current strained US-Chinese relations, impacting biotech cooperation. Learn more about the implications and challenges.
Fierce Pharma
JUNE 3, 2024
As Japanese chemical giant Asahi Kasei continues its foray into the biopharma contract manufacturing space, the company’s biologics CDMO is expanding its offerings to include starting materials for | Asahi’s U.S. subsidiary Bionova Scientific is launching a new business line to provide services around plasmid DNA (pDNA), the companies announced Monday.
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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.
pharmaphorum
JUNE 3, 2024
GSK planning to refile anti-BCMA drug Blenrep in the US for multiple myeloma after reporting positive results from the DREAMM-8 trial at ASCO
Outsourcing Pharma
JUNE 3, 2024
In a resounding declaration of commitment to womenâs health, Discovery Park, Kentâs well-known life science and innovation community, has unveiled its latest cohort of trailblazing FemTech start-ups.
Fierce Pharma
JUNE 3, 2024
The decision of a Delaware judge on Friday to allow more than 75,000 Zantac lawsuits to go forward to jury trials has left four major drugmakers—GSK, Pfizer, Sanofi and Boehringer Ingelheim—vulnera | The decision of a Delaware judge on Friday to allow more than 75,000 Zantac lawsuits to go forward to jury trials has left four major drugmakers—GSK, Pfizer, Sanofi and Boehringer Ingelheim—vulnerable to costly awards, settlements and litigation fees as they try to resolve claims that the heartburn
pharmaphorum
JUNE 3, 2024
Join us for live coverage of BIO 2024, featuring Viola Davis and Brooke Baldwin on Day 1. Stay tuned for exclusive updates and highlights from the event.
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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.
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