Medical Xpress
MAY 17, 2023
After hearing firsthand from patients about how the disease impacted their lives, a team of researchers and graduate students at University of Western Ontario were inspired to investigate the symptoms associated with an understudied spine disease called diffuse idiopathic skeletal hyperostosis (DISH).
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.
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Pharmaceutical Technology
MAY 19, 2023
The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). Formerly known as NOV03, Miebo is a first-in-class eye drop designed for preventing the evaporation of excessive tears and restoring tear balance in evaporative DED patients.
Fierce Pharma
MAY 19, 2023
Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease zbecker Fri, 05/19/2023 - 16:25
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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 17, 2023
With scarce clinical resources unable to keep pace with elevated rates of mental illness, technological solutions could help decrease waitlists and disparities in access to therapy. Recent advances in artificial intelligence have fueled interest in the use of chatbots and virtual assistants for mental health treatment.
Bio Pharma Dive
MAY 17, 2023
Spun out of the lab of former UCSF researcher Nicole Paulk, the biotech is targeting brain and eye tumors with a new kind of treatment it has dubbed “immuno-gene therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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
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.
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 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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
MAY 19, 2023
Intercept's NASH dreams may be dashed after FDA panel votes against Ocaliva's approval bid fkansteiner Fri, 05/19/2023 - 17:30
Medical Xpress
MAY 17, 2023
Soil-transmitted helminth infections are caused by different species of parasitic worms, including whipworms, hookworms and roundworms. Worldwide, more than 1.5 billion people are infected with at least one soil-transmitted helminth, with most of the infected population living in low- and middle-income countries.
Bio Pharma Dive
MAY 19, 2023
The biotech, best known for its vaccine research, said its clinical trial is the first to report results of a messenger RNA therapeutic designed for intracellular protein replacement.
Pharmaceutical Technology
MAY 19, 2023
Myeloid Therapeutics has raised $73m to support the continued clinical development of its lead cell therapy programme, MT-101, in Phase I/II trials for T cell lymphoma. Led by Hatteras Investment Partners, the financing round has seen participation from existing investors, including 8VC, Alexandria Venture Investments and Newpath Partners, along with new investors Moore Strategic Ventures and ARCH Venture Partners.
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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.
Fierce Pharma
MAY 17, 2023
Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type aliu Wed, 05/17/2023 - 09:41
Medical Xpress
MAY 15, 2023
Fresh insights into the spread of damaging proteins that build up in the brains of people with Alzheimer's disease could hold the key to stopping the condition from progressing, a study says.
Bio Pharma Dive
MAY 15, 2023
The Dutch biotech sold a portion of royalties owed by CSL Behring on sales of Hemgenix, adding to a cash pile it has built since out-licensing the treatment.
Pharmaceutical Technology
MAY 19, 2023
Multiple sclerosis (MS) is a primary autoimmune disease in which inflammation is a core contributor to the degeneration of the central nervous system (CNS), leading to neurological disability and affecting sensory, visual, motor, and autonomic systems. While MS is not a terminal diagnosis, the effect of the disease on the CNS can significantly impact patients’ independence and disturb their daily lives.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
MAY 19, 2023
AbbVie, Genmab's lymphoma drug Epkinly snags FDA approval in heated blood cancer race aliu Fri, 05/19/2023 - 11:21
Medical Xpress
MAY 15, 2023
The traces of genetic material that humans constantly shed wherever they go could soon be used to track individual people, or even whole ethnic groups, scientists said on Monday, warning of a looming "ethical quagmire".
Bio Pharma Dive
MAY 17, 2023
The company said its “reversible” BTK inhibitor, which trails competitors from Sanofi and Merck KGaA, succeeded in Phase 2 testing without raising new safety concerns.
Pharmaceutical Technology
MAY 17, 2023
Chinook Therapeutics and Ionis Pharmaceuticals have entered a partnership to develop an antisense oligonucleotide (ASO) therapy to treat a rare, severe chronic kidney disease. The collaboration aims to discover, develop and commercialise an ASO therapy. It will use the precision medicine approach, as well as the deep expertise of Chinook Therapeutics in nephrology and knowledge of Ionis Pharmaceuticals in RNA-targeted therapeutics.
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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.
Fierce Pharma
MAY 19, 2023
Bausch + Lomb bags FDA approval for dry eye disease treatment Miebo zbecker Fri, 05/19/2023 - 09:39
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.
Bio Pharma Dive
MAY 17, 2023
The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.
Pharmaceutical Technology
MAY 15, 2023
The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. This marks the first-ever FDA approval of a nonhormonal neurokinin 3 (NK3) receptor antagonist for use against vasomotor symptoms caused by menopause.
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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 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
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.
Bio Pharma Dive
MAY 19, 2023
The panel voted 14-0 that Pfizer’s data showed its shot to be effective. The vaccine could be the first for protecting infants by maternal immunization.
Pharmaceutical Technology
MAY 17, 2023
The US Food and Drug Administration (FDA) has accepted and granted priority review to Takeda ’s biologics licence application (BLA) for its enzyme replacement therapy, TAK-755, to treat congenital thrombotic thrombocytopenic purpura (cTTP). By replacing the missing or deficient ADAMTS13 enzyme, TAK-755 offers targeted therapy for addressing an unmet medical need for thrombotic thrombocytopenic purpura patients.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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