Bio Pharma Dive
NOVEMBER 27, 2023
One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.
Pharmaceutical Technology
NOVEMBER 27, 2023
Olvi-Vec is currently being evaluated in a Phase III trial as a treatment for platinum- resistant/refractory ovarian cancer.
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Worldwide Clinical Trials
NOVEMBER 27, 2023
By: Amy Raymond, PMP, PhD, Senior Director, Therapeutic Strategy Lead, Cellular & Genetic Medicines On November 16, the British regulatory body, Medicines and Healthcare products Regulatory Agency (MHRA) approved exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease for patients ages 12 and up, becoming the first gene editing treatment to receive regulatory approval.
Rethinking Clinical Trials
NOVEMBER 27, 2023
The National Institutes of Health’s Office of Disease Prevention (ODP) issued a new funding opportunity to support implementation studies in treatment and prevention for alcohol, tobacco, and other drugs use and misuse in adult populations that experience health disparities. ODP and participating NIH Institutes and Centers are inviting applications for research projects that test innovative approaches to implementing screening, brief intervention, and referral to treatment or prevention fo
Bio Pharma Dive
NOVEMBER 27, 2023
Results from the second of two Phase 3 trials testing the blockbuster drug in the respiratory condition showed treatment could reduce attacks and improve lung function.
Pharmaceutical Technology
NOVEMBER 27, 2023
High-quality monitoring and trial oversight procedures are essential for avoiding the serious consequences that come protocol deviations, poor data quality, and regulatory issues.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 27, 2023
Mocravimod is currently being investigated in a global Phase III study in AML patients undergoing haematopoietic stem cell transplantation.
Bio Pharma Dive
NOVEMBER 27, 2023
The planned $2.3 billion investment follows an earlier $6 billion commitment to expand manufacturing for drugs like its in-demand medicine Wegovy.
Pharmaceutical Technology
NOVEMBER 27, 2023
AbbVie epcoritamab: The monoclonal antibody, approved to treat certain B-cell lymphomas, received an FDA breakthrough therapy designation.
BioPharma Reporter
NOVEMBER 27, 2023
It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.
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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
NOVEMBER 27, 2023
The UK NICE has recommended the usage of Alexion sebelipase alfa for the treatment of Wolman disease in infants and toddlers on the NHS.
BioSpace
NOVEMBER 27, 2023
Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
Pharmaceutical Technology
NOVEMBER 27, 2023
Sanofi and Regeneron plan to submit the supplemental data from the two Phase III trials of Dupixent to the US FDA by the end of 2023.
Antidote
NOVEMBER 27, 2023
The cornea is the outermost layer of the human eye, serving both as a protective covering and allowing light into the retina. To perform this function, the cornea is made up of several layers, the outermost of which is known as the epithelium.
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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
NOVEMBER 27, 2023
The UK MHRA has issued a recall of batches of carbomer-containing lubricating eye gels due to potential microbial contamination.
XTalks
NOVEMBER 27, 2023
The intersection of patient safety, technology and innovation in the pharmaceutical industry has given rise to substantial changes in medical information and pharmacovigilance. This dynamic landscape is marked by the integration of patient-centric approaches, real-world evidence and cutting-edge technologies. Pharmaceutical companies are navigating the challenges and opportunities presented by AI-driven analytics, wearable devices and patient-generated data, redefining how adverse events are det
Pharmaceutical Technology
NOVEMBER 27, 2023
Novartis has announced a voluntary recall of two lots of its 100mg/mL Sandimmune Oral Solution over crystallisation issues.
Fierce Pharma
NOVEMBER 27, 2023
After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. | After plotting $6 billion in production upgrades earlier this month, Novo Nordisk’s CEO Lars Fruergaard Jørgensen suggested the expansion outlay was just the start. Now, some three weeks later, he’s putting his company’s money where his mouth is.
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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
NOVEMBER 27, 2023
Everest Medicines has received approval from China's NMPA for its Nefecon to treat primary IgAN in adult patients.
Fierce Pharma
NOVEMBER 27, 2023
Eli Lilly’s fortunes have turned quickly. | It was the second straight quarter where the overwhelming success of blood sugar regulating treatments were the dominant story in the biopharma industry. Eli Lilly and Novo Nordisk delivered the highest revenue gains, at 38% and 29%, respectively.
Pharmaceutical Technology
NOVEMBER 27, 2023
Autolus Theraputics is forging ahead with its T-cell cancer therapy, obe-cel, aimed at treating persistant adult ALL.
Intouch Solutions
NOVEMBER 27, 2023
Attending college, choosing a major, and then finding a career that aligns with your education and evokes passion can be much more difficult than it seems. Many students may find their passion while in college but are unsure how that degree translates in the real world post-graduation. Simi Krishnan, Senior Vice President, Analytics, has worked in analytics for nearly 20 years and has grown her career in the field, starting as an analyst through data science and now in a leadership role.
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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.
XTalks
NOVEMBER 27, 2023
Amicus Therapeutics has recently received approval from the US Food and Drug Administration (FDA) for its drugs Pombiliti (cipaglucosidase alfa-atga) and Opfolda (miglustat) for adults living with late-onset Pompe disease (LOPD) who are not improving on their current enzyme replacement therapy (ERT). “FDA approval of Pombiliti and Opfolda is a testament to the power of science, medicine and our passionate determination to improve the lives of people living with Pompe disease.
FDA Law Blog
NOVEMBER 27, 2023
By Riëtte van Laack & Anne K. Walsh — Although the Consumer Product Safety Act (CPSA) has been around for over 50 years to “protect the public against unreasonable risks of injury associated with consumer products,” it was not until 2008 that the statute was amended to authorize the Consumer Product Safety Commission (“CPSC”) to impose criminal liability against individual directors, officers, or agents of a corporation for violating the CPSA.
Pharma Times
NOVEMBER 27, 2023
The IRP will bring life-saving medicines to UK patients from 1 January 2024 - News - PharmaTimes
pharmaphorum
NOVEMBER 27, 2023
EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.
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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
NOVEMBER 27, 2023
Following the historic approval of the world’s first CRISPR-based gene-editing therapy in the United Kingdom this month, Vertex Pharmaceuticals has tapped its long-time manufacturing partner Roslin | RoslinCT, the CDMO arm of the Roslin Institute, is set to manufacture Vertex and CRISPR Therapeutics’ exa-cel “across the world” as part of Vertex’s global production network.
XTalks
NOVEMBER 27, 2023
Solving the opioid epidemic long-term requires bringing new, safe and better treatments to market to replace the reliance on opioids in the clinical setting. The development of a non-addictive, non-opioid treatment or an adjunct treatment that could reduce the needed opioid dosage would revolutionize how we treat pain. However, the industry is facing significant challenges in developing these therapies, including the weak ability of preclinical data to predict clinical success and insufficient f
BioSpace
NOVEMBER 27, 2023
The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
Pharma Times
NOVEMBER 27, 2023
Around £330m will be invested in the software over the next seven years - News - PharmaTimes
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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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