5 FDA decisions to watch in the fourth quarter
Bio Pharma Dive
OCTOBER 2, 2023
The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.
Sat.Sep 30, 2023 - Fri.Oct 06, 2023
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Empowering patients: How to match to clinical trials
Antidote
OCTOBER 3, 2023
Clinical trials are an integral part of the medical industry, as they are required for any new treatment to be approved. Every medicine used today, whether prescription or over the counter, is a result of the rigorous research process that is a clinical trial — and for these trials to take place, volunteers are vital.
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Clinical Research Nurse Vs Clinical Trials Coordinator
ECRG Media's Clinical Research Podcast
OCTOBER 5, 2023
Clinical Research Nurse Vs Clinical Trails Coordinator Don't forget to Subscribe for new content! Merch: [link] Subscribe: / eliteclinicalresearch Email: eliteclinicalgroup@gmail.com Podcast: [link] Steemit: [link] Advertise: eliteclinicalgroup@gmail.com Watch: » Industry News: [link] » All Videos: [link] » Interview Recaps: [link] » Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Revi
How biotech IPOs performed in the third quarter
Bio Pharma Dive
OCTOBER 3, 2023
Only two of the eight biotech companies that priced offerings since July 1 trade at or above their debut share price, according to data from BioPharma Dive.
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
Navigating EAPs: Clinical trials and the path to investigational drugs
pharmaphorum
OCTOBER 4, 2023
Navigating EAPs: Clinical trials and the path to investigational drugs Mike.
Internship Program Boosts Clinical Research Workforce Development in Pennsylvania
ACRP blog
OCTOBER 3, 2023
Lessons learned from a new clinical research internship program held in central Pennsylvania last summer have helped prepare new and upcoming entrants for the research workforce, as well as to inform how the next generation of the program will evolve. As reported by the Penn State College of Medicine , six interns spent 11 weeks taking active roles in existing research projects, immersing themselves in the conduct of research, and learning more about careers in clinical research at the college’s
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Lilly to enter radiopharmaceutical drug field with $1.4B Point buyout
Bio Pharma Dive
OCTOBER 3, 2023
The deal will hand Lilly a pipeline of experimental radioligand therapies, including a potential rival to Novartis’ Pluvicto, as well as a valuable manufacturing plant.
Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
Advarra
OCTOBER 4, 2023
When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. A robust corrective and preventive action (CAPA) stands as a critical tool for proactively addressing those non-conformities. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfa
FDA lifts partial hold on Phase III plans for rare ataxia drug
Pharmaceutical Technology
OCTOBER 2, 2023
An NDA submission for EryDex is currently intended for Q4 2025, assuming positive Phase III study results.
Australian Seaweed Boosts Collagen Levels in Human-Like Skin Cells in The Lab
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 3, 2023
If you believe the headlines, seaweeds can do almost anything from storing tons of carbon and stopping cows from belching methane, to making biofuels and renewable plastics – all while sustaining vibrant coastal ecosystems and feeding communities.
NIH funds research for three experimental ALS drugs
Bio Pharma Dive
OCTOBER 6, 2023
The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.
October 2, 2023: Patient-Centered Outcomes Core Develops Tool Kit to Promote Health Equity in PROs
Rethinking Clinical Trials
OCTOBER 2, 2023
The Patient-Centered Outcomes Core has developed a new tool kit to provide resources to support the capture of patient-reported outcome (PRO) measures in diverse study populations. The tool kit is intended for research teams conducting pragmatic clinical trials, including those participating in the NIH Pragmatic Trials Collaboratory’s Demonstration Projects.
Lumicell co-founder wins Nobel Prize in Chemistry
Pharmaceutical Technology
OCTOBER 5, 2023
Lumicell co-founder, Moungi Bawendi, has been awarded the accolade alongside two others for his research into quantum dots.
Amazing Advance in Spinal Repair Allows Injured Mice to Walk Again
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 2, 2023
Researchers have reversed ‘irreversible paralysis’ in mice with complete spinal cord injuries using gene therapy. The team found that regrowing neurons is not enough to fully restore walking and that regenerative therapies must target specific neurons and guide them back to where they belong, which was previously unknown.
The New Age of Decentralized Clinical Trials
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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
Moderna claims positive results in early study for combo COVID, flu shot
Bio Pharma Dive
OCTOBER 4, 2023
The company is planning to start a Phase 3 trial of the vaccine this year, and is targeting a regulatory approval in 2025.
Fewer MS patients are prescribed DMTs in UK compared to Europe
Pharma Times
OCTOBER 2, 2023
The study analysed and compared information from 65,000 MS patients - News - PharmaTimes
Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines
Pharmaceutical Technology
OCTOBER 2, 2023
The Physiology and Medicine Prize has gone to two researchers whose work laid the foundation for Pfizer and Moderna’s Covid-19 vaccines.
Rising Addiction to Milk Tea Linked to Depression in Adolescents
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 5, 2023
Milk teas – a variety of sweet drinks including bubble tea – have become phenomenally popular in China and other parts of Asia in recent years, and a new study has highlighted some worrying links between the beverage and mental health issues.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Orchard sells to Kyowa Kirin in gene therapy buyout
Bio Pharma Dive
OCTOBER 5, 2023
Kyowa will pay nearly $400 million to acquire Orchard, which sells the gene therapy Libmeldy in Europe but has struggled to find paths to market for other experimental treatments.
AstraZeneca reveals new research to improve drug discovery
Pharma Times
OCTOBER 6, 2023
The study used data from 50,000 people in the UK Biobank - News - PharmaTimes
Ocular launches ocular implant trial to combat macular degeneration
Pharmaceutical Technology
OCTOBER 6, 2023
Ocular Therapeutix has confirmed the launch of a trial of an intravitreal eye implant intended to combat macular degeneration.
AI Identifies Brain Signals Associated With Recovering From Depression
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 4, 2023
It could soon be possible to measure changes in depression levels like we can measure blood pressure or heart rate. In a new study, 10 patients with depression that had resisted treatment were enrolled in a six-month course of deep brain stimulation (DBS) therapy.
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.
Apellis sales numbers show steady demand for new eye drug, despite safety worries
Bio Pharma Dive
OCTOBER 5, 2023
The company says Syfovre prescriptions accelerated again in August after a rocky summer of side effect probes.
October 5, 2023: GRACE Trial Featured on CBS News Chicago for Sickle Cell Awareness Month
Rethinking Clinical Trials
OCTOBER 5, 2023
The GRACE trial, an NIH Pragmatic Trials Collaboratory Demonstration Project, was featured in a segment on CBS News Chicago. Co–principal investigator Ardith Doorenbos was interviewed for the segment as part of the news program’s observance of Sickle Cell Awareness Month. “Millions of people around the world with sickle cell disease really suffer from very serious chronic pain, which impacts all their life experiences,” Doorenbos said. “What the GRACE trial is doing is ta
Viatris announces plan to divest some businesses for $3.37bn
Pharmaceutical Technology
OCTOBER 3, 2023
Drug manufacturer Viatris has announced the divestment of a number of businesses owned by the company in a $.37bn deal.
Advanced, portable & intuitive diagnostic tools aid accurate dengue & malaria test reports
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 5, 2023
Advanced, portable and intuitive diagnostic tools are considerably benefiting the Indian healthcare to tackle diseases such as dengue and malaria. Easily transportable and convenient diagnostics systems are invaluable in remote areas, aiding timely diagnosis and patient care.
Regeneron, Intellia target neurological diseases in expanded gene editing deal
Bio Pharma Dive
OCTOBER 3, 2023
The longtime partners believe that, by combining their technologies, they can create “in vivo” genetic medicines for nervous system and muscular disorders.
October 4, 2023: Special Biostatistics Grand Rounds Series Begins Friday With Rigorous Methods for Hybrid Studies
Rethinking Clinical Trials
OCTOBER 4, 2023
In this Friday’s PCT Grand Rounds, David Murray of the NIH Office of Disease Prevention will kick off our special series, Advances in the Design and Analysis of Pragmatic Clinical Trials, with his presentation, “Hybrid Studies Should Not Sacrifice Rigorous Methods.” The session will be held on Friday, October 6, at 1:00 pm eastern and will be moderated by Jonathan Moyer.
Strides Pharma gets FDA greenlight to market HIV treatment
Pharmaceutical Technology
OCTOBER 4, 2023
Strides earned market approval in the US as part of a larger government endeavor to address HIV worldwide.
Health ministry issues notification to include antiviral drugs oseltamivir & zanamivir into Schedule H1
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 4, 2023
The Union health ministry has issued a draft notification to include antiviral drugs oseltamivir and zanamivir into the Schedule H1 of the Drug Rules, 1945, allowing the retailers to store and sell the drug against prescription by maintaining a separate record for the details of the particular sales.
The New Age of Decentralized Clinical Trials
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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.
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