Bio Pharma Dive
MAY 3, 2023
The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 3, 2023
Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinical trial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection.
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Bio Pharma Dive
MAY 3, 2023
The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.
Pharmaceutical Technology
MAY 3, 2023
Janssen Biotech and the Cellular Biomedicine Group (CBMG) have entered a global collaboration and licence agreement for the development of next-generation chimeric antigen receptor (CAR) T-cell therapies to treat B-cell malignancies. Janssen will gain exclusive rights to develop and commercialise CBMG’s CAR-T assets, C-CAR039 and C-CAR066, excluding the greater China region.
Bio Pharma Dive
MAY 3, 2023
The deal comes months after Magenta reported a clinical trial setback, began a strategy review of its business and laid off most of its workforce.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 3, 2023
The Department of Pharmaceuticals (DoP) has approved the applications of five medical devices companies under the production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices, in the category it has added through an amendment of guidelines in August, 2022.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
MAY 3, 2023
Dr. Joshua Denny, All of Us Research Program (Photo: Vanderbilt University Medical Center) In this Friday’s PCT Grand Rounds, Joshua Denny of the All of Us Research Program at NIH, will present “ All of Us Research Program: Improving Health Through Diverse Technology, Huge Cohorts, and Precision Medicine.” The Grand Rounds session will be held on Friday, May 5, 2023, at 1:00 pm eastern.
Bio Pharma Dive
MAY 3, 2023
Ron Renaud, who previously ran and sold two other biotechnology companies, will step in for Tony Coles and lead Cerevel, a Pfizer spinout developing a closely watched schizophrenia drug.
Pharmaceutical Technology
MAY 3, 2023
PharmaTher has submitted a fast track application for Ketarx (ketamine) to the US Food and Drug Administration (FDA) to treat levodopa-induced dyskinesia in Parkinson’s disease (LID-PD). The FDA-approved N-methyl-D-aspartate receptor-modulating (NDMA) drug ketamine is leveraged as an anaesthetic agent either alone or along with other anaesthetic agents.
Medical Xpress
MAY 3, 2023
Scientists of the Princess Máxima Center for pediatric oncology and Hubrecht Institute in the Netherlands have revealed new scientific insights into the features of fibrolamellar carcinoma (FLC), a rare type of childhood liver 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
Pharmaceutical Technology
MAY 3, 2023
Tay Therapeutics, a spin-off firm from the University of Dundee in the UK, has signed a licensing deal with VYNE Therapeutics for the development of its oral bromodomain and extra-terminal domain (BET) inhibitor as a possible treatment for immune-inflammatory and fibrotic disorders. Tay will receive $50m in upfront and milestone payments, along with royalties.
Medical Xpress
MAY 3, 2023
A new study shows that sleep spindles, brief bursts of brain activity occurring during one phase of sleep and captured by EEG, may regulate anxiety in people with post-traumatic stress disorder (PTSD).
Pharmaceutical Technology
MAY 3, 2023
BrightPath Biotherapeutics and Artisan Bio have signed a research and licensing agreement to expedite the former’s allogeneic next-generation invariant natural killer T (iNKT) cell therapies to clinic. BrightPath will obtain non-exclusive rights to the STAR-CRISPR editing platform of Artisan Bio for accelerating the development of BrightPath’s iNKT cells.
Medical Xpress
MAY 3, 2023
A team of researchers at Los Alamos National Laboratory recently published the most comprehensive study of global COVID-19 variant transitions, which showed significant diversity in variant spread around the globe related to vaccination rates, number of co-circulating variants and immunity from previous infection. The paper was published in eBioMedicine.
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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
MAY 3, 2023
Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares. The antibody received the designation as an investigational treatment to prevent flares in adolescents and adults. The Center for Drug Evaluation of China’s National Medical Products Administration has also awarded a BTD to spesolimab.
Medical Xpress
MAY 3, 2023
Antibiotics administered before and during surgery should be discontinued immediately after a patient's incision is closed, according to updated recommendations for preventing surgical site infections. Experts found no evidence that continuing antibiotics after a patient's incision has been closed, even if it has drains, prevents surgical site infections.
Pharmaceutical Technology
MAY 3, 2023
Aurinia Pharmaceuticals has received marketing authorisation from the Swiss Agency for Therapeutic Products (Swissmedic) for Lupkynis (voclosporin), along with a background immunosuppressive therapy. Lupkynis is a new structurally modified calcineurin inhibitor (CNI) indicated for the treatment of active class III, IV and V (including mixed classes III/V and IV/V) lupus nephritis (LN) in adult patients.
Medical Xpress
MAY 3, 2023
Researchers at the Department of Psychiatry and Psychology, Center for Behavioral Health, Neurological Institute at the Cleveland Clinic in Ohio have authored a case report on the positive effects of psilocybin on color blindness.
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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.
Fierce Pharma
MAY 3, 2023
ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win aliu Wed, 05/03/2023 - 14:50
Medical Xpress
MAY 3, 2023
A new Nature Immunology study led by University of Pittsburgh and National Institutes of Health researchers sheds light on how a rare type of helper T cell, called Th9, can drive allergic disease, suggesting new precision medicine approaches to treating allergies in patients with high levels of Th9.
Antidote
MAY 3, 2023
Every May is dedicated to Skin Cancer Awareness Month — a national observance designed to raise awareness around skin cancer and encourage people to practice smart prevention tactics as spring transitions into summer. Though skin cancer is the most common type of cancer , forming good sun safety habits can have a direct link to a reduction in its prevalence.
Medical Xpress
MAY 3, 2023
Heart conduction disorders can often lead to serious or fatal complications including complete heart block or heart failure. Left ventricular conduction disease occurs when there is an electrical blockage of the heart's normal electrical conduction system. Treatment to lessen its effects involves implanting a permanent pacemaker, but there have been no proven preventive strategies for this condition.
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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
MAY 3, 2023
Founded in 2020, ZOA Energy is a relatively new player in the energy drink market. The brand was created by Dwayne Johnson (“The Rock”), along with his business partners, John Shulman and Danny Garcia. The goal of ZOA Energy was to create a healthy, all-natural energy drink that would give consumers the boost they need without the negative side effects associated with many other energy drinks on the market.
Medical Xpress
MAY 3, 2023
Prostate cancer frequently metastasizes to the bone and is incurable. Moffitt Cancer Center researchers are working to identify new treatment options for this subset of patients. In a new article published today in Science Advances, a team of Moffitt scientists demonstrates that chimeric antigen receptor T-cell (CAR T) therapy is an effective antitumor approach in mouse models of bone metastatic prostate cancer.
Pharma Times
MAY 3, 2023
Recommendation applies across England and Wales and the treatment is available now
Medical Xpress
MAY 3, 2023
A treatment to prevent runaway inflammation in patients with severe COVID-19 is a step closer after a University of Queensland-led study into how immune cells respond to the virus.
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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.
Pharma Times
MAY 3, 2023
The wide-ranging research aims to unlock the potential of angiotensin II type 2 receptor agonists
Medical Xpress
MAY 3, 2023
"Mindfulness" practices may help parents of young children with autism manage their daily stressors, and it could benefit their kids in the process, a preliminary study suggests.
Fierce Pharma
MAY 3, 2023
EU countries lay out framework for combating drug shortages zbecker Wed, 05/03/2023 - 17:04
Medical Xpress
MAY 3, 2023
Scientists from the Lee Kong Chian School of Medicine (LKCMedicine) at Nanyang Technological University, Singapore (NTU Singapore) have found that Asians with an excess amount of visceral fat tend to have a poorer ability to think, learn, and remember.
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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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