Bio Pharma Dive
MAY 18, 2023
At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.
Pharmaceutical Technology
MAY 18, 2023
The European Medicines Agency (EMA) has published recommendations to increase communication and planning efforts in a bid stop the current medicine shortages becoming even worse. Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.
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AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 18, 2023
A new study reports something strange: When mice with Alzheimer’s disease inhale menthol, their cognitive abilities improve. It seems the chemical compound can stop some of the damage done to the brain that’s usually associated with the disease.
Bio Pharma Dive
MAY 18, 2023
The court's rejection of Amgen's arguments is a win for Regeneron in a long-running case over the companies' competing cholesterol drugs, and could have broad implications for the industry.
Pharmaceutical Technology
MAY 18, 2023
HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer. The application is supported by positive results from the Phase III CARES 310 randomised, open-label, international trial.
Bio Pharma Dive
MAY 18, 2023
The regulator is probing the business practices of two more drug purchasing organizations, deepening an investigation that began last year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 18, 2023
The biotech joins a score of other cell and gene therapy developers that, on the heels of a historic market downturn, have been forced to cut costs.
Pharmaceutical Technology
MAY 18, 2023
LAPIX Therapeutics has secured a US patent for LPX-TI641 , its orally administered Tim3/4 agonist for regulatory T cell (Treg) expansion for the treatment of autoimmune diseases. Patent number 11,648,225 has been issued by the US patent and trademark office. LPX-TI641 restores the Treg population using an antigen-agnostic method to treat autoimmune diseases.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 18, 2023
The Union health ministry has notified the standards of public and private healthcare institutions to ensure accessibility of healthcare facilities and services to the persons with disabilities.
Pharmaceutical Technology
MAY 18, 2023
The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment. This move shows the FDA’s determination to accept the NDA as a class 2 review that leads to a six-month evaluation period starting from the resubmission date.
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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 18, 2023
Diabetes researchers at Washington University School of Medicine in St. Louis have uncovered at least one reason insulin-secreting cells made from stem cells in the lab don't work as well as natural cells. The discovery could help speed progress toward making insulin-secreting cells—called islet beta cells—more effective in the treatment of insulin-dependent type 1 diabetes.
Pharmaceutical Technology
MAY 18, 2023
International non-profit research organisation IAVI and Zendal Group’s subsidiary Biofabri have signed an expanded deal to develop MTBVAC, a tuberculosis (TB) vaccine candidate. The organisation and the company initially collaborated in 2021 to advance the vaccine candidate into efficacy trials. MTBVAC is being developed by Biofabri along with IAVI, the University of Zaragoza and the Europe-based tuberculosis vaccine initiative (TBVI).
Outsourcing Pharma
MAY 18, 2023
A small molecule drug has been recommended by Englandâs National Institute for Health Care and Excellence (NICE) for the treatment of adults with moderate to severe chronic kidney disease (CKD)-associated pruritus in adult patients on haemodialysis.
Pharmaceutical Technology
MAY 18, 2023
Gate Neurosciences plans to start a Phase II study of its lead candidate zelquistinel in major depressive disorder (MDD) in Q4 2023, said Rob Houghtaling, Sr. Director of Corporate Development, in an interview with Pharmaceutical Technology. The company finished an initial Phase IIa efficacy study, which showed a rapid antidepressant signal of the compound, says Houghtaling.
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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
Pharma Times
MAY 18, 2023
The therapy is a brain-penetrant used in various combinations in patients with progressive glioblastoma
Pharmaceutical Technology
MAY 18, 2023
Non-profit organisations the Max Foundation and the BeiGene Foundation have partnered with global technology company BeiGene to offer access to Brukinsa (zanubrutinib) in 29 low and middle-income countries between 2023 and 2026. Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor that will be used to treat chronic lymphocytic leukaemia (CLL) in adult patients.
Medical Xpress
MAY 18, 2023
The mechanisms underlying the pathogenesis of epilepsy, a neurological disorder characterized by excessive electrical activity in the brain, remain unknown. Now, using a novel radiotracer ([11C]K-2, the first technology to visualize and quantify α-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor (AMPAR) in the living human brain), researchers from Japan have been able to offer insight into the role of AMPAR trafficking in epileptogenesis.
Pharmaceutical Technology
MAY 18, 2023
KSQ Therapeutics has announced the expansion of its immuno-oncology strategic partnership with Takeda for new tumour-intrinsic targets. This partnership will focus on the identification and validation of new targets to inform treatment developments that address resistance mechanisms in cancer patients. The agreement between KSQ and Takeda expands their ongoing collaboration focused on identifying natural killer (NK) and T-cell targets.
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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 18, 2023
Our bodies burn carbohydrates, proteins, and fat for fuel, and now, researchers at the Broad Institute of MIT and Harvard and the University of Lausanne have discovered another important energy source for cells: uridine, the chemical building block unique to RNA.
Pharmaceutical Technology
MAY 18, 2023
Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI). An investigational orally delivered biologic drug, LMN-201 is a cocktail of four therapeutic proteins that act synergistically to neutralise the C difficile bacterium and the toxin.
Intouch Solutions
MAY 18, 2023
Google’s new generative AI search integration, Search Generative Experience (SGE) is going to evolve the old familiar search results page. Codenamed Magi , right now it’s only experimental, and is only available for some searches, and only for users who opt into Search Labs. But what’s it look like, and where’s it going? Well, we’ve gathered some key points that healthcare search marketers should know, from this excellent article from The Verge and other sources!
Pharmaceutical Technology
MAY 18, 2023
Forbion European Acquisition has entered a definitive business combination agreement with biotechnology company enGene to create a combined biotechnology company to develop next-generation non-viral, locally administered gene therapies. The combined company will be named enGene Holdings and its common shares are expected to be listed on the Nasdaq. Funding for the deal includes $20m from the existing investment of Forbion Growth in FEAC Class A shares, along with PIPE investment, other private i
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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 18, 2023
Many people perceive that they are night owls or morning larks, and that can't be changed. It's called a chronotype—your body's need for sleep at a certain time—and it is generally considered to be unchangeable. However, a new study from researchers with Baylor University's Sleep Neuroscience and Cognition Laboratory shows that chronotypes are more flexible than originally thought.
Antidote
MAY 18, 2023
Clinical Trials Day takes place on May 20 each year, and is a day to celebrate the thousands of medical research volunteers who participate in trials for a wide range of conditions. It's also a day to raise awareness of the fact that even more volunteers are needed to push medical research forward.
Medical Xpress
MAY 18, 2023
Could we temporarily increase brain plasticity in adults to decrease fear and anxiety responses in people who have experienced trauma? CHU Sainte-Justine Neuroscientist Graziella Di Cristo and her team were determined to find out. In a new study on mice, she was able to control fear responses by inducing desensitization to fear memories simultaneously with a temporary increase in brain malleability through control of gene activation.
BioPharma Reporter
MAY 18, 2023
Sania Therapeutics, a new biotech company focused on developing genetic medicines for neural circuit dysfunction, has launched by unveiling its suite of proprietary patented platforms at the American Society of Gene & Cell Therapy (ASGCT) conference.
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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 18, 2023
A team of bioinformatics researchers affiliated with multiple institutions in the U.S. and Aarhus University in Denmark is proposing a new metric to quantify genetic dissimilarities between an individual and a training population. Their study is reported in the journal Nature. The editors at Nature have also published a Research Briefing in the same journal issue outlining the work done by the team on this effort.
Pharma Times
MAY 18, 2023
The approved drug has been developed to treat patients with moderate to severe Crohn’s disease
Medical Xpress
MAY 18, 2023
Every year, more people die of kidney disease than breast cancer. The Centers for Disease Control and Prevention estimates that 37 million people in the United States—15% of U.S. adults—have some form of chronic kidney disease.
Fierce Pharma
MAY 18, 2023
Teva's new CEO Francis lays out his 'pivot to growth' strategy kdunleavy Thu, 05/18/2023 - 11:24
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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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