BioSpace
OCTOBER 8, 2023
Recent FDA approvals of novel drugs based on less-than-stellar clinical evidence point to a trend toward regulatory flexibility—particularly in indications with very high unmet need.
pharmaphorum
OCTOBER 30, 2023
Clinical trial disparities and how to build a more inclusive future Mike.
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Fierce Pharma
OCTOBER 25, 2023
After misconduct at a key trial site raised questions of | The FDA previously uncovered evidence of forged emails and trial misconduct in the company's phase 3 Alzheimer's disease agitation study. Now, with a third-party audit in hand, BioXcel looks to push forward with the drug.
BioSpace
OCTOBER 26, 2023
New platforms are emerging to help biopharma companies fill their human studies more efficiently, but barriers remain to their successful implementation.
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
pharmaphorum
OCTOBER 27, 2023
On a journey to diverse, inclusive, and more efficient rare disease trials Mike.
BioSpace
OCTOBER 31, 2023
Optimizing Biomarker Assays to Bridge the Clinical Trial Participation Gap - read this article along with other careers information, tips and advice on BioSpace
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Antidote
OCTOBER 20, 2023
Since 1999, October has been designated as Health Literacy Month , a month dedicated to promoting patient-centricity in healthcare communications across the industry. Health literacy refers to a person’s ability to find, understand, and use health-related services and make informed decisions for themselves and others.
pharmaphorum
OCTOBER 27, 2023
Evolving with the patient: Optimising CAGT post-trial long-term follow-up Mike.
Bio Pharma Dive
OCTOBER 10, 2023
There have been few bigger-ticket acquisitions recently. But a string of deals announced in early October may affirm the forecasts of analysts who expect M&A to tick up in the coming months.
Pharmaceutical Technology
OCTOBER 18, 2023
The FDA approved Hyloris’s non-opioid painkiller as the agency increases efforts to mitigate an opioid crisis.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2023
In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.
Worldwide Clinical Trials
OCTOBER 31, 2023
Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. However, with a greater number of trials, sponsors and CROs face an increased risk of operational challenges, and sites continue to feel the widespread effects of the COVID-19 pandemic. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.
Rethinking Clinical Trials
OCTOBER 12, 2023
In a new article published this week in Contemporary Clinical Trials Communications, the GRACE Demonstration Project team recommends that suicidality should be monitored in pragmatic clinical trials that measure depression as an outcome. The work builds on their experience conducting research involving patients with sickle cell disease and on previous work from the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.
Fierce Pharma
OCTOBER 16, 2023
As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.
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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
OCTOBER 11, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
Pharmaceutical Technology
OCTOBER 24, 2023
SpeechDx will contain recorded voice samples and other data, which will be used to develop algorithms for creating new speech biomarkers.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 31, 2023
After a bump, we can expect a bruise. But what if we find ourselves bruising without any noticeable cause? What might be behind it? Should we worry? Around 18 percent of adults report easy bruising. As hematologists (blood doctors), we are often asked for advice when people are worried they might bruise too easily.
Pharma Mirror
OCTOBER 30, 2023
Indonesia, being the fourth most populous country in the world, presents a significant market opportunity for medical device manufacturers. The Indonesia medical device registration process is a necessary pathway for any foreign manufacturer looking to supply their products in this burgeoning market. The growth potential is immense due to the increasing healthcare expenditure and growing awareness about advanced medical technologies among the population.
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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.
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.
Fierce Pharma
OCTOBER 30, 2023
Editor's note: This story has been updated with a comment from Pfizer. An earlier version of the story stated that nearly 800 jobs would be affected. | After plunging COVID revenues prompted Pfizer to embark on a cost-cutting crusade, more details about the company's savings efforts are coming into focus.
Bio Pharma Dive
OCTOBER 23, 2023
The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.
Pharmaceutical Technology
OCTOBER 18, 2023
Lisata has received orphan drug designation from the EMA's Committee for Orphan Medicinal Products for LSTA1 to treat pancreatic cancer.
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
OCTOBER 29, 2023
For those with stubbornly resistant forms of severe depression, ketamine was looking more and more like a solution. Years of research has hinted at the dissociative anesthetic’s treatment potential where other medications failed, promising the benefits of electroshock therapy with far fewer risks.
Worldwide Clinical Trials
OCTOBER 24, 2023
In the US, a rare disease is one with 200,000 or fewer patients. Rare diseases exist in every therapeutic area and are often the more complex indications of each therapeutic area. While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.
Rethinking Clinical Trials
OCTOBER 31, 2023
The NIH Pragmatic Trials Collaboratory is excited to announce the addition of 5 new large-scale pragmatic clinical trials to its portfolio of innovative Demonstration Projects, which will extend the program’s mission to strengthen the national capacity to implement cost-effective, large-scale research studies that engage healthcare delivery organizations as research partners.
Fierce Pharma
OCTOBER 16, 2023
Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Bio Pharma Dive
OCTOBER 13, 2023
Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.
Pharmaceutical Technology
OCTOBER 17, 2023
In October 2023, Novo Nordisk announced that its trial studying Ozempic (semaglutide) in diabetic CKD patients, will come to a halt almost a year prior to its planned completion.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 9, 2023
Getting up at least 50 steps a day is associated with a more than 20 percent cut in the risk of cardiovascular disease, new research shows – so you may only need to climb five flights of stairs per day to significantly boost your heart health.
Pharma Mirror
OCTOBER 16, 2023
Van Nieuwenhove succeeds Mark Egerton, who retires after 18 years in the role Wayne Hewett also joins Quotient Board of Directors as Non-Executive Chairman NOTTINGHAM, UK: Quotient Sciences (“Quotient” or the “Company”), a leading global pharmaceutical drug development and manufacturing accelerator, is pleased to announce the appointment of Thierry Van Nieuwenhove as its new Chief Executive Officer (CEO), effective 16th October 2023.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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