AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 4, 2024
Diagnoses for sexually transmitted infections, or STIs, are increasing in older adults. The Centers for Disease Control and Prevention reports the number of people older than 65 diagnosed with chlamydia, gonorrhea or syphilis in the U.S. increased about three-, five- and sevenfold, respectively, from 2010 to 2023.
Bio Pharma Dive
AUGUST 6, 2024
Through a new deal, Roche has exclusive rights to Sangamo molecules designed to repress the gene that makes “tau,” a protein many scientists view as a main driver of Alzheimer’s.
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Pharmaceutical Technology
AUGUST 8, 2024
Novartis has secured US Food and Drug Administration (FDA) accelerated approval for Fabhalta (iptacopan) to treat igAN.
Rethinking Clinical Trials
AUGUST 7, 2024
In this Friday’s PCT Grand Rounds, Greg Simon and Susan Shortreed of the Kaiser Permanente Washington Health Research Institute (KPWHRI) will present “Does Starting Buprenorphine Prevent Suicidal Behavior? What Trial Should We Emulate?” The Grand Rounds session will be held on Friday, August 9, 2024, at 1:00 pm eastern. Simon is a senior investigator at KPWHRI and a research professor of psychiatry and behavioral sciences at the University of Washington.
Rethinking Clinical Trials
AUGUST 8, 2024
Speaking at the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, Commissioner of Food and Drugs Robert Califf and NIH Director Monica Bertagnolli discussed the intersection of pragmatic research and national health priorities. Califf and Bertagnolli spoke about the role the NIH Collaboratory can play in promoting scientifically rigorous, pragmatic clinical research that addresses the urgent need for better and faster implementation of research findings into pat
Bio Pharma Dive
AUGUST 9, 2024
The decision to turn down an application from Lykos Therapeutics comes at a pivotal time for psychedelics research, which, after decades of dismissal, has recently gained momentum.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2024
Last week, the Australian Therapeutic Goods Administration added intravenous (IV) fluids to the growing list of medicines in short supply. The shortage is due to higher-than-expected demand and manufacturing issues. Two particular IV fluids are affected: saline and compound sodium lactate (also called Hartmann’s solution). Both fluids are made with salts.
Worldwide Clinical Trials
AUGUST 9, 2024
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials. By allowing protocol adjustments based on interim data analysis, these designs preserve the integrity of studies while effectively addressing the unique challenges of multi-regional clinical trials (MRCTs).
Bio Pharma Dive
AUGUST 9, 2024
Recent data from J.P. Morgan indicates early-stage startups are getting smaller upfront payments in alliances than a few years ago, a trend industry insiders attribute to weaker leverage in deal talks.
Pharmaceutical Technology
AUGUST 6, 2024
Antengene received approval from the Malaysian National Pharmaceutical Regulatory Agency for XPOVIO NDA for two multiple myeloma indications.
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2024
Scientists think they may have found locations in the brain where schizophrenia first emerges, potentially making the neurological disorder’s onset easier to diagnose from a standard MRI brain scan.
Rethinking Clinical Trials
AUGUST 6, 2024
Materials and videocast recordings are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues. “ The 2-day workshop, hosted by the NIH, featured a keynote address by NIH Director Monica Bertagnolli exploring how to identify high-priority healthcare issues that require the effort, time, and funding of a clinical trial.
Bio Pharma Dive
AUGUST 6, 2024
The funding from Apple Tree Partners will help the startup advance an antiviral drug pipeline that includes a COVID treatment nearing mid-stage testing.
Pharmaceutical Technology
AUGUST 9, 2024
Days after competitor Novo Nordisk posted underwhelming Wegovy sales, Eli Lilly cited “strong performance” for Zepbound and Mounjaro.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2024
The Indian healthcare sector is now concerned on quality and accuracy of Point-of-Care (PoC) diagnostic test results. This apprehension is because of limited training or experience with these devices and those handling the same. Hands-on practice and ongoing education to remain updated with changes in technology are issues.
Fierce Pharma
AUGUST 5, 2024
While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market. | While Pfizer’s German mRNA partner BioNTech has high hopes for its post-COVID future, the company continues to feel the squeeze from the changeover to a seasonal vaccine market.
Bio Pharma Dive
AUGUST 8, 2024
Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.
Pharmaceutical Technology
AUGUST 5, 2024
The European Commission (EC) has granted orphan drug designation (ODD) for Amylyx Pharmaceuticals’ AMX0035 to treat Wolfram syndrome.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 5, 2024
Oral diseases, such as tooth decay and gum disease, are among the the most widespread chronic illnesses globally – affecting an estimated 3.5 billion people. They pose a significant problem not just because of how common they are, but because they can cause serious health complications.
Fierce Pharma
AUGUST 5, 2024
The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from | The family of a Baltimore woman whose cells were extracted for medical research without her consent more than 70 years ago has filed another lawsuit against drugmakers that allegedly profited from the discoveries they made using her genetic material.
Bio Pharma Dive
AUGUST 8, 2024
After months of supply strains, Lilly has begun to catch up with demand. Consumers may still need to wait for their prescriptions to be filled, however.
Pharmaceutical Technology
AUGUST 8, 2024
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' CREXONT extended-release capsules for PD.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 7, 2024
India continues to face significant challenges in boosting its organ donation rates, currently languishing at just over one per million population. Despite widespread public support, the country struggles to increase its organ donation rates, due in part to a combination of legal misconceptions, lack of awareness within the medical community, and cultural barriers.
Fierce Pharma
AUGUST 8, 2024
Following the commercial launch of Bavarian Nordic’s smallpox/mpox vaccine Jynneos earlier this year, the Danish company has locked up yet another supply agreement with the U.S. government. | The Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic $156.8 million to “partly replenish” Jynneos vaccine stocks in response to the 2022 outbreak of mpox, the disease formerly known as monkeypox.
Bio Pharma Dive
AUGUST 7, 2024
Quarterly revenue from Ozempic and Wegovy missed Wall Street estimates by about 9%, concerning some analysts and causing a stock sell-off costing the Danish drugmaker tens of billions in market value.
Pharmaceutical Technology
AUGUST 6, 2024
GSK has announced the win in the latest trial concerning allegations that its heartburn medication Zantac was linked to cancer.
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 5, 2024
The Drug Discovery & Development Workshop 2024 is set to be a cornerstone event for professionals and students in the pharmaceutical and biotechnology sectors. The workshop is organized by the National Institute of Animal Biotechnology (NIAB) and the Federation of Asian Biotech Associations (FABA), with the support of various institutional and knowledge partners.
pharmaphorum
AUGUST 6, 2024
Discover how the innovative geko device is driving clinical change in UK stroke care. Learn how this technology is revolutionising the treatment and management of stroke patients.
Bio Pharma Dive
AUGUST 7, 2024
Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.
Pharmaceutical Technology
AUGUST 8, 2024
Conduit plans to advance two assets, AZD1656 and AZD5658, into Phase II testing for autoimmune disorders.
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