Bio Pharma Dive
MAY 12, 2023
Advisers voted 8-6 in favor of an accelerated approval despite uncertainty around the treatment’s benefit. The agency is set to make a final decision by May 29.
Pharmaceutical Technology
MAY 12, 2023
The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. Blood cancer patients with E coli infection are at risk of bacteria infecting the bloodstream. An E coli infection can be fatal in these cases, with a 15-20% mortality rate.
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Bio Pharma Dive
MAY 12, 2023
Cyclerion Therapeutics has struck an agreement to sell two of its experimental drugs, known as sGC stimulators, to a newly formed company in exchange for cash and equity.
Pharmaceutical Technology
MAY 12, 2023
Takeda has reported a 12.8% increase in its reported revenue to $29.96bn (Y4,027bn) during the fiscal year 2022 (FY2022) compared to that reported in FY2021. At a constant exchange rate (CER), the company’s core revenue grew by 3.5% compared to the previous year. In the FY2022 ending 31 March 2023, the company also reported a 6.4% rise in its operating profit to $3.65bn (Y490.5bn) compared to 2021.
Bio Pharma Dive
MAY 12, 2023
The antibody reduced RSV infections requiring hospitalization by 83% in a large study, bolstering evidence for the drug ahead of a U.S. approval decision later this year.
Pharmaceutical Technology
MAY 12, 2023
Editas Medicine will release new efficacy and safety results of its gene therapy EDIT-301 in severe sickle disease as part of an oral presentation at the European Hematology Association’s (EHA) Hybrid Congress. The EHA Hybrid Congress will take place on June 8-11 in Frankfurt, Germany. Last month, the US Food and Drug Administration (FDA) granted the treatment an orphan drug designation for sickle cell disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 12, 2023
On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. The agent is a human epidermal growth factor receptor 2 (HER2)-targeting ADC that utilises Eisai’s chemotherapy Halaven (eribulin) as its payload. Under the agreement, BlissBio will receive an undisclosed sum in upfront and milestone payments, and the companies will codevelop BB-1701 through an option per
Medical Xpress
MAY 12, 2023
Identifying people at high risk for suicide is critical for applying lifesaving interventions and treatments. However, it is very difficult to identify who is at greatest risk and only modest improvements has been made in identifying high risk people over the last 50 years. One novel way to identify people at high risk of suicide is by investigating and identifying brain markers.
Pharmaceutical Technology
MAY 12, 2023
BioNTech has ended its research collaboration with Matinas after its oral mRNA vaccine failed to demonstrate preclinical activity. Matinas announced the news in a May 10 statement. The in vivo study, conducted in mice, involved a phosphatidylserine-containing nano-formulation of mRNA supplied by BioNTech, distinct from traditional lipid nanocrystals (LNCs).
Medical Xpress
MAY 12, 2023
Two specialized researchers, one with the Leibniz-Institut für Wissensmedien (the Knowledge Media Research Center), the other with the Applied Face Cognition Lab at the University of Lausanne, have validated reports that some people have super-recognizing abilities. In their study, reported in Proceedings of the National Academy of Sciences, Maren Mayer and Meike Ramon analyzed data from eyewitnesses of ongoing bank robberies in Fribourg, Switzerland, helping to identify two suspects.
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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 12, 2023
Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab. In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.
Medical Xpress
MAY 12, 2023
Alzheimer's disease (AD) is a progressive neurodegenerative disorder affecting tens of millions of people worldwide, and it is the most common cause of dementia. Early-onset AD is typically associated with mutations in the genes APP, PSEN1, and PSEN2, leading to a more aggressive form of the disease with atypical symptoms. In contrast, the newly discovered "Shanghai APP" mutation has been linked to LOAD, which affects a larger population of AD patients.
Pharmaceutical Technology
MAY 12, 2023
Early-stage life sciences investment fund NYBC Ventures has launched its new $50m fund to speed up developments in the fields of blood and cellular therapies and related technologies. The New York Blood Center (NYBC) has provided the investment for the inaugural fund. NYBC Ventures will focus on investment in therapeutics, devices and new technologies to address issues in benign haematology, transfusion medicine and infectious disease.
Medical Xpress
MAY 12, 2023
There's a glimmer of good news when it comes to the mental health of America's adolescents: Visits to U.S. emergency departments for psychiatric troubles declined among kids aged 12 to 17 by the fall of 2022, compared to a year prior.
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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 12, 2023
The Institute of Cancer Research (ICR), along with its hospital partner The Royal Marsden NHS Foundation Trust, has opened a new joint integrated pathology unit (IPU). The IPU is the first centre of its kind in England and aims to enhance cancer diagnosis and treatment by integrating digital imaging with artificial intelligence (AI). The IPU will support clinical trial research and will employ new technology to diagnose cancer in a faster and less expensive way.
Medical Xpress
MAY 12, 2023
A new editorial paper, titled "The senescence-associated secretory phenotype induces neuroendocrine transdifferentiation," was recently published in the journal Aging
Pharmaceutical Technology
MAY 12, 2023
Absci has collaborated with the University of Oxford’s Kennedy Institute of Rheumatology to expedite the development of AI-driven immunotherapies. The collaboration will use the integrated drug creation platform of Absci and the clinical immunology datasets from the Kennedy Institute to identify antibodies to immune-mediated inflammatory diseases and autoimmune conditions with unprecedented speed.
Medical Xpress
MAY 12, 2023
Head and neck cancer (HNC) is an overarching term used for several types of cancer, including the most common form called head and neck squamous cell carcinoma (HNSCC). HNC patients can be treated with a combination of surgery, radiotherapy and/or chemotherapy. Nevertheless, treatment is not always effective.
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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
MAY 12, 2023
Angelini Pharma has entered an exclusive global development and commercialisation deal with JCR Pharmaceuticals to develop and commercialise new biologic therapies to treat epilepsy. The partnership will combine Angelini Pharma’s expertise in neurological diseases with the scientific and technological strengths of JCR Pharmaceuticals for delivering biotherapeutics across the blood-brain barrier.
Medical Xpress
MAY 12, 2023
Physicists and bioengineers can manipulate magnetically driven guidewires by using remote magnetic steering with scope for minimally invasive medical procedures. Magnetic steering strategies are presently limited by low magnetic fields, thereby preventing their integration in medical systems operating at ultrahigh fields, including magnetic resonance imaging (MRI) scanners.
XTalks
MAY 12, 2023
Rett syndrome is a rare genetic disorder that predominantly affects girls and leads to severe physical and cognitive impairments. It affects around one in 10,000 girls born each year. Named after Austrian physician Andreas Rett, who first described the condition in 1966, Rett syndrome primarily manifests in early childhood, typically between six months and two years of age.
Medical Xpress
MAY 12, 2023
In Europe, epidemics of highly pathogenic avian influenza (HPAI) used to be a seasonal phenomenon associated with migratory waterfowl that were returning to their overwintering sites in the autumn. Since 2020, however, this picture has changed. HPAI viruses, particularly of the influenza A(H5) subtype, have caused the worst epidemics in birds observed to date, with more than 14,000 reported outbreaks and culling of roughly 96 million farmed birds in Europe.
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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.
Pharma Times
MAY 12, 2023
Confederation responds to generally positive statistics, including cancer backlog drop
Medical Xpress
MAY 12, 2023
Long COVID risk has been found to increase with low levels of vitamin D, according to research presented at the 25th European Congress of Endocrinology in Istanbul. The findings suggest that individuals should have their vitamin D levels checked after COVID-19.
Fierce Pharma
MAY 12, 2023
As pharma fights IRA, Senate moves forward basket of bills aimed at lower drug prices aliu Fri, 05/12/2023 - 10:48
Medical Xpress
MAY 12, 2023
Vivek Murthy, the US surgeon general, recently warned that "being socially disconnected" has a similar effect on mortality as smoking up to 15 cigarettes a day. This statement was widely reported in the media, including in the Washington Post, the Times and the Daily Mail. But where does this "15 cigarettes a day" figure come from?
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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 12, 2023
The first unit of its kind in England will identify biomarkers and diagnose cancer much faster
Medical Xpress
MAY 12, 2023
If you were one of the millions of people who watched HBO's TV series "The Last of Us," you probably have a heightened awareness of the threat that fungi can have to our health.
Fierce Pharma
MAY 12, 2023
Pfizer CEO Bourla slams Medicare IRA measure as 'negotiation with a gun to your head' kdunleavy Fri, 05/12/2023 - 10:32
Medical Xpress
MAY 12, 2023
Cardiologists at the UW Medicine Heart Institute recently performed a first-in-the-world procedure, detaching and retrieving a clip device from a patient's mitral valve and placing a replacement biologic valve—all through a catheter. Previously this sequence of tasks had been performed only via open surgery.
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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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