Bio Pharma Dive
MAY 4, 2023
After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.
Pharmaceutical Technology
MAY 4, 2023
Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.
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Bio Pharma Dive
MAY 4, 2023
The $540 million offering adds to a small, but growing body of evidence suggesting young drugmakers may need to be well into clinical testing before going public.
Pharmaceutical Technology
MAY 4, 2023
Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 4, 2023
Scientists from the University of Michigan in the US have detected a surge of activity in the brains of two people as they transitioned into death, with the phenomenon similar to spikes of brain activity seen previously in animals whose hearts had stopped beating.
Bio Pharma Dive
MAY 4, 2023
U.S. suppl of Novo’s Wegovy will be “reduced temporarily,” while the Danish drugmaker gets a new contract manufacturer up and running, executives said Thursday.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 4, 2023
At more than $400 billion, Lilly’s market value is nearing J&J’s despite the company earning less than one-third as much revenue. Strong data for medicines donanemab and Mounjaro are why.
Pharmaceutical Technology
MAY 4, 2023
Magenta Therapeutics has signed a definitive merger agreement to combine its business with clinical-stage biotechnology firm Dianthus Therapeutics. The all-stock deal will see the creation of a new entity that will support further development of Dianthus’ new complement inhibitors pipeline, including DNTH103, which is currently in a Phase I study. The consolidated firm will run under the Dianthus Therapeutics brand and trade on the Nasdaq under the ‘DNTH’ ticker symbol.
Bio Pharma Dive
MAY 4, 2023
Separating out the consumer health division will leave J&J as a slimmed-down company focused on prescription drugs and medical devices.
Pharmaceutical Technology
MAY 4, 2023
Clinical-stage biotechnology firm ARTHEx Biotech has raised $46.36m (€42m) in a Series B financing round to advance its lead compound, ATX-01, to treat myotonic dystrophy type 1 (DM1), a rare progressive muscle-wasting disease. Led by Columbus Venture Partners, the financing round has seen the participation of existing investors the Centre for the Development of Industrial Technology (CDTI), AdBio Partners and Invivo Capital.
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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
Medical Xpress
MAY 4, 2023
Secondary bacterial infection of the lung (pneumonia) was extremely common in patients with COVID-19, affecting almost half the patients who required support from mechanical ventilation. By applying machine learning to medical record data, scientists at Northwestern University Feinberg School of Medicine found that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19.
Pharmaceutical Technology
MAY 4, 2023
Idorsia has received marketing authorisation from Health Canada for Quviviq (daridorexant) to manage insomnia in adult patients. The dual orexin receptor antagonist (DORA) Quviviq acts on orexin 1 and orexin 2 receptors equipotently. It blocks only the orexin receptors activation that promote wakefulness, rather than inducing sleep through broad inhibition of brain activity (sedation).
Medical Xpress
MAY 4, 2023
About a third of children with autism aren't able to speak—but that doesn't mean they're unable to listen and comprehend, a new study reports.
Pharmaceutical Technology
MAY 4, 2023
Bristol Myers Squibb has received approval from the European Commission (EC) for its cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel) to treat relapsed or refractory large B-cell lymphoma (LBCL) in adult patients. The therapy is indicated to treat diffuse LBCL (DLBCL) primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and follicular lymphoma grade 3B (FL3B) in adult patients whose disease relapsed within 12 months of completion of first-line chemoimmu
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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
Medical Xpress
MAY 4, 2023
Talking on a mobile for 30 minutes or more per week is linked with a 12% increased risk of high blood pressure compared with less than 30 minutes, according to research published today in European Heart Journal—Digital Health.
XTalks
MAY 4, 2023
Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. The symptoms of celiac disease can vary and may involve abdominal pain, bloating, diarrhea, weight loss, fatigue and anemia.
Medical Xpress
MAY 4, 2023
Neuropathic pain—abnormal hypersensitivity to stimuli—is associated with impaired quality of life and is often poorly managed. Estimates suggest that 3% to 17% of adults suffer from neuropathic pain, including a quarter of people with diabetes and a third of people with HIV.
Pharma Times
MAY 4, 2023
The treatment is a small molecule that activates endogenous retinal stem and progenitor cells
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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.
Medical Xpress
MAY 4, 2023
Monash University researchers have discovered a key mechanism in the body's immune system that helps control the inflammatory response to infection. The discovery could help pave the way for more targeted therapies in a range of inflammatory conditions, such as autoimmunity and neuroinflammatory disease.
Pharma Times
MAY 4, 2023
Patent will allow the development of an industrial biomarker analysis kit which could be available worldwide
Medical Xpress
MAY 4, 2023
The p53 gene is one of the most important in the human genome: the only role of the p53 protein that this gene encodes is to sense when a tumor is forming and to kill it. While the gene was discovered more than four decades ago, researchers have so far been unsuccessful at determining exactly how it works. Now, in a recent study published in Cancer Discovery, researchers at The Wistar Institute have uncovered a key mechanism as to how p53 suppresses tumors.
Outsourcing Pharma
MAY 4, 2023
Results from a multinational trial of trifluridine/tipracil, known as Lonsurf, with or without bevacizumab in refractory metastatic colorectal cancer (mCRC) have resulted in statistically significantly and clinically meaningful improvements.
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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.
Medical Xpress
MAY 4, 2023
Despite the astounding advances made in understanding the biologic underpinnings of cancer, many cancers are missing obvious genetic drivers. When scientists can't pinpoint the factors that drive cancer, treating it can be much more difficult.
Fierce Pharma
MAY 4, 2023
Moderna warns of severe sales slowdown in Q2, takes $378M charge amid lull in vaccinations aliu Thu, 05/04/2023 - 10:02
Medical Xpress
MAY 4, 2023
In a study of 17 people from five families, Johns Hopkins Medicine researchers say they found that ultra-lengthy DNA endcaps called telomeres fail to provide the longevity presumed for such people. Instead, people with long telomeres tend to develop a range of benign and cancerous tumors, as well as the age-related blood condition clonal hematopoiesis.
Fierce Pharma
MAY 4, 2023
J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58
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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.
Medical Xpress
MAY 4, 2023
University of Alberta researchers have identified a neurochemical marker related to the loss of motor function and communication breakdown between the primary motor cortex—the part of the brain that controls our muscles—and the rest of the brain in ALS patients. Knowing this, they're now aiming to find out whether the marker might also offer a test to evaluate new treatments to improve brain function.
Fierce Pharma
MAY 4, 2023
As Eylea sales fall again, Regeneron looks forward to approval of its longer-lasting follow-up kdunleavy Thu, 05/04/2023 - 11:00
Medical Xpress
MAY 4, 2023
Scientists from Singapore have demonstrated the critical role played by a special transporter protein in regulating the brain cells that ensure nerves are protected by coverings called myelin sheaths. The findings, reported by researchers at Duke-NUS Medical School and the National University of Singapore in the Journal of Clinical Investigation, could help to reduce the damaging impacts of ageing on the brain.
BioSpace
MAY 4, 2023
AstraZeneca, Pfizer Top 2023 Pharma List for Invention and Innovation 5/5/2023
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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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