Sat.May 13, 2023 - Fri.May 19, 2023

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New research sheds light on symptoms of understudied spine disease

Medical Xpress

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).

Research 119
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Teva puts rival to Prometheus, Pfizer drugs at center of turnaround plans

Bio Pharma Dive

At an investor day, executives highlighted an experimental inflammatory disease drug targeting the protein TL1A as important to their long-term growth prospects.

Drugs 360
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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

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.

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Eating Late Can Alter How You Burn Calories And Store Fat, Depressing Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

A recent study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Krystal's Vyjuvek becomes first topical gene therapy with FDA nod to treat rare skin disease

Fierce Pharma

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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Biotech startup Ray raises $100M for vision-restoring gene therapies

Bio Pharma Dive

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.

More Trending

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Mouse Study Reveals Unlikely Connection Between Menthol And Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Protein 242
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Tonsillectomy both cost- and clinically effective for adults, finds study

Medical Xpress

Scientists say tonsil removal is both cost- and clinically effective for adults who get recurrent severe sore throats.

Scientist 144
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UniQure sells royalty rights to hemophilia gene therapy

Bio Pharma Dive

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.

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EMA issues guidance amidst European medicine shortage

Pharmaceutical Technology

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”.

Medicine 249
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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New Alzheimer’s Drug Shows 35% Reduction in Cognitive Decline in Late-Stage Trial

AuroBlog - Aurous Healthcare Clinical Trials blog

American pharmaceutical company Eli Lilly announced last week that it had seen encouraging clinical trial results of its new Alzheimer’s medication. According to the company, their experimental drug, donanemab, was shown in a late-stage trial to slow cognitive decline by 35 percent.

Trials 238
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AI voice coach shows promise in psychotherapy for depression and anxiety

Medical Xpress

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.

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Siren emerges from stealth with plans to marry gene therapy to cancer immunotherapy

Bio Pharma Dive

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.

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Myeloid raises funds to support lead cell therapy programme

Pharmaceutical Technology

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.

In-Vivo 246
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Popular Obesity Drug Turns Out to Have a Secret Cancer-Killing Effect

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Drugs 234
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An elusive mechanism of wasting syndrome cachexia revealed

Medical Xpress

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.

Genetics 141
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Moderna reports ‘encouraging’ early data for one of its rare disease medicines

Bio Pharma Dive

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.

RNA 305
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MIF invests in Nectin to investigate multiple myeloma drug candidate

Pharmaceutical Technology

Multiple Myeloma Research Foundation’s (MMRF) venture philanthropy subsidiary Myeloma Investment Fund (MIF) has made an undisclosed investment in Nectin Therapeutics to assess the potential of NTX1088 to treat multiple myeloma. Along with the MIF’s investment, Nectin has so far secured more than $33m from aMoon, Peregrine Ventures, Israel Biotech Fund, Cancer Focus Fund and Integra.

Drugs 246
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How Machine Learning Drives Clinical Trial Efficiency

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.

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There’s One Critical Thing We Can All Do to Keep Alzheimer’s Symptoms at Bay

AuroBlog - Aurous Healthcare Clinical Trials blog

Deep sleep could be key to forestalling slow declines in brain health that may one day lead to Alzheimer’s disease, the most common form of dementia.

Research 233
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New treatment for human parasitic worm infections shows high efficacy

Medical Xpress

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.

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Roche pushes forward with MS drug amid rivals’ setbacks

Bio Pharma Dive

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.

Drugs 264
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Cost of disease-modifying therapies for multiple sclerosis continues to rise in US

Pharmaceutical Technology

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.

Marketing 246
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Ministry of Ayush and ICMR sign MoA for collaboration in research for integrated medicine

AuroBlog - Aurous Healthcare Clinical Trials blog

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.

Medicine 188
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Dementia study reveals how toxic proteins spread through brain

Medical Xpress

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.

Protein 138
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PTC’s drug for PKU succeeds in late-stage clinical trial

Bio Pharma Dive

The biotech plans to discuss the study results with regulators to determine next steps toward an approval application for the rare disease treatment.

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FDA gives go-ahead on labelling for Cumberland’s therapy for fever and pain in infants

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age. The newly approved label features information about the product’s indications and usage, suitable patient groups, clinical trial results, potential side effects and patient safety

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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ICMR successfully conducts trial run of blood bag delivery under the iDrone initiative

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Council of Medical Research (ICMR) has successfully conducted a trial run of blood bag delivery by drones under the iDrone initiative in continuance with the national mission of expanding drone ecosystem in India.

Trials 187
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Shift work may harm the health of men more than women

Medical Xpress

Working nights can be tough on the body, and a new study suggests it might take a particular toll on men's health.

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Nido debuts with $109M for its precision approach to brain drugs

Bio Pharma Dive

Backed by 5AM Ventures and Eli Lilly, the startup has advanced a drug for spinal and bulbar muscular atrophy into clinical testing.

Drugs 264
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Chinook and Ionis partner to develop ASO therapy for kidney disease

Pharmaceutical Technology

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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The New Age of Decentralized Clinical Trials

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.