Bio Pharma Dive
MAY 16, 2023
Founded in early 2021, the company is using optogenetics to design treatments that could work across disease genotypes and in the later stages of vision loss.
Pharmaceutical Technology
MAY 16, 2023
The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. This news was announced during the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles.
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Bio Pharma Dive
MAY 16, 2023
The latest startup from one of biotech’s most prolific company creators has $50 million to explore a new way of designing medicines.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 16, 2023
A popular obesity drug has been found to restore the function of immune cells that target cancer, regardless of whether people lost weight with the treatment.
Bio Pharma Dive
MAY 16, 2023
The regulator’s challenge will test a more expansive view of how pharmaceutical mergers could harm consumers. Amgen remains confident it can complete the deal, however.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 16, 2023
In a move to strengthen the country’s health infrastructure and to integrate and mainstream Ayush sector, the Ministry of Ayush and the Indian Council of Medical Research (ICMR) have signed a Memorandum of Agreement (MoA).The MoA is for collaboration and cooperation in health research in the field of integrated medicine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 16, 2023
Backed by nearly $100 million, the public-private consortium aims to create a standard development roadmap for gene therapies using AAV viral vectors.
Pharmaceutical Technology
MAY 16, 2023
More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. This resulted in a 3.4% decline in total aggregate market capitalisation from $3.61 trillion in Q4 2022 to $3.49 trillion in Q1 2023, according to GlobalData’s pharma intelligence centre companies database. Although 12 of the top 20 players reported negative growth in market capitalisation, eight companies saw positive growth with five companies achieving double-digit growth to more
Medical Xpress
MAY 16, 2023
Researchers from the Department of Molecular Biology and Genetics at Koc University in Turkey and the Pole of Endocrinology, Diabetology and Nutrition, Institute of Experimental and Clinical Research at Université Catholique de Louvain in Belgium, have collaborated to interrogate the mechanisms behind a cancer-associated wasting syndrome—cachexia.
Pharmaceutical Technology
MAY 16, 2023
Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. The merged entity represents one of the biggest specialist generic injectable operations in Canada with local manufacturing facilities. It will benefit from Omega’s newly opened injectable manufacturing facility, which has received clearances from Health Canada and the US Food and Drug Administration, as well as from Juno’s commercial network and pr
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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
Bio Pharma Dive
MAY 16, 2023
The California-based company now has partnerships in place with Sanofi, Biogen and Lilly’s Prevail.
Pharmaceutical Technology
MAY 16, 2023
Dutch biopharmaceutical company Byondis has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics licence application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). The CRL states that the FDA is suspending its decision and requests additional information, which will need time and resources to consider that might extend beyond the present evaluation period.
Medical Xpress
MAY 16, 2023
Inspired by sutures developed thousands of years ago, MIT engineers have designed "smart" sutures that can not only hold tissue in place, but also detect inflammation and release drugs.
Pharmaceutical Technology
MAY 16, 2023
Bavarian Nordic has completed the acquisition of Emergent BioSolutions ’ travel vaccine portfolio for an upfront payment of $274m, with the potential for the total value to rise to $384m. The deal encompasses Vivotif and Vaxchora, both marketed vaccines for the prevention of typhoid fever and cholera respectively, and a Phase III vaccine candidate for the prevention of Chikungunya virus, which have now all been transferred to Bavarian Nordic.
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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 16, 2023
Artificial sweeteners, used to replace sugar in a vast range of products, do not help in losing weight and can have serious health effects, according to the World Health Organization.
Pharmaceutical Technology
MAY 16, 2023
Health Canada has accepted a new drug submission (NDS) for Eisai and Biogen ’s lecanemabto to treat early Alzheimer’s disease (AD). Lecanemab, the brand name of which is LEQEMBI in the US, is indicated to treat mild cognitive impairment caused due to AD and mild AD in people with confirmed presence of amyloid pathology in the brain. Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody directed against aggregated soluble (protofibril), as well as insoluble forms of Aβ.
Medical Xpress
MAY 16, 2023
A new paper published by leading Australian AI ethicist Stefan Harrer Ph.D. proposes for the first time a comprehensive ethical framework for the responsible use, design, and governance of Generative AI applications in health care and medicine.
Pharmaceutical Technology
MAY 16, 2023
ImmPACT Bio has received fast track designation (FTD) from the US Food and Drug Administration (FDA) for IMPT-314 to treat relapsed or refractory (R/R) aggressive B-cell lymphoma. IMPT-314 is indicated to treat B-cell mediated malignancies, including R/R aggressive B-cell lymphoma, high-grade B cell lymphoma (HGBCL), diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) and primary mediastinal B-cell lymphoma.
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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 16, 2023
How do our brains become capable of creating specific memories? In one of the first preclinical studies to examine memory development in youth, a research team at The Hospital for Sick Children (SickKids) may have identified a molecular cause for memory changes in early childhood.
Drug Patent Watch
MAY 16, 2023
On NPR’s All Things Considered, Sydney Lupkin asked DrugPatentWatch if drug patents could be used to identify injector pens which could then be swapped to fix drug shortages. Referring to… The post NPR and DrugPatentWatch – Can drug injector pens be swapped? appeared first on DrugPatentWatch - Make Better Decisions.
Medical Xpress
MAY 16, 2023
Children whose families participated in a program that helped them move from distressed neighborhoods to areas with lower rates of poverty and better public resources like schools and parks experienced significant improvements in severe asthma episodes, according to a new study led by a researcher at Dell Medical School at The University of Texas at Austin.
XTalks
MAY 16, 2023
Pulmonary fibrosis is a chronic and progressive lung disease characterized by the scarring and thickening of the lung tissues. This condition leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe and obtain an adequate oxygen supply. The term “pulmonary fibrosis” encompasses a group of disorders that share similar pathological changes in the lungs.
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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 16, 2023
Diet drinks often contain a mix of non-nutritive sweeteners that also enter the bloodstream after consumption. As a new pilot study shows, even dietary intake levels of saccharin, acesulfame-K and cyclamate are enough to modulate the copy rate of various genes in white blood cells.
ACRP blog
MAY 16, 2023
This is a sponsored message. Clinical trials have been the foundation of medical research for almost 250 years. James Lind, a Scottish naval surgeon and physician, is widely credited with performing the first comparative clinical trial. Dr. Lind’s study, which began on May 20, 1747, carefully evaluated different regimens, including citrus fruit, for the treatment of scurvy (vitamin C deficiency).
Medical Xpress
MAY 16, 2023
Primates are among the most intelligent creatures with distinct cognitive abilities. Their brains are relatively large in relation to their body stature and have a complex structure. However, how the brain has developed over the course of evolution and which genes are responsible for the high cognitive abilities is still largely unclear. The better our understanding of the role of genes in brain development, the more likely it will be that we will be able to develop treatments for serious brain
XTalks
MAY 16, 2023
Did you know that medical record management costs a staggering $125 billion per year in the US? This inefficient system is heavily based on paper records and is putting healthcare providers at a significant disadvantage. On average, clinical staff spends 20 percent of their daily time chasing down patient records. Moreover, paper medical records occupy valuable storage space in hospitals and offices.
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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 16, 2023
New research suggests that centenarians—people who live to be at least 100—have a diverse collection of viruses in their gut that could help protect them from infectious diseases. The findings, published May 15 in Nature Microbiology, shed light on some of the biological pathways that may help centenarians live long, healthy lives.
Pharma Tutor
MAY 16, 2023
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) : Making Quality Medicines Affordable and Accessible in India admin Tue, 05/16/2023 - 15:25 About Author Ramraj Choudhary M.Pharma, (Pharmaceutics) Dr. H.S Gour University, Sagar MP Current Position : Sr.
Medical Xpress
MAY 16, 2023
Breast cancer is resistant to immunotherapies; therefore, bioengineers and oncologists seek to develop a slew of therapeutic strategies to overcome this challenge. In a new report in Science Advances, Kerui Wu and colleagues in the departments of cancer biology, translation biology and breast surgery in the U.S., and China engineered active immunotherapy to create smart nanovesicles for personalized treatment.
Fierce Pharma
MAY 16, 2023
FTC seeks to block Amgen's $28B Horizon buy in 'broadly negative' move for biopharma M&A: report aliu Tue, 05/16/2023 - 09:41
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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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