Sat.Nov 16, 2024 - Fri.Nov 22, 2024

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Scientists Say This One Particular Diet May Slow The Decline of The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

(Flavio Coelho/Moment/Getty Images) While it’s not possible to stop the brain from aging – at least not yet – there might be ways to slow down its decline, and a new study shows the vital role blood sugar levels play in how rapidly the brain ages.

Scientist 163
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FDA endorses speedy approval path for Regenxbio Duchenne gene therapy

Bio Pharma Dive

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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Sage’s string of research failures continues

Bio Pharma Dive

Negative results from a Huntington’s trial add to a calamitous year for Sage, which last month decided to overhaul its research, reconfigure its executive team and lay off a third of its staff.

Research 154
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FDA approves Syndax’s Revuforj to treat leukaemia

Pharmaceutical Technology

The US FDA has approved Syndax Pharmaceuticals' Revuforj (revumenib) for treating acute leukaemia with KMT2A translocation.

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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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November 20, 2022: In This Week’s PCT Grand Rounds, the HeLiX Pragmatic Trial in Patients Undergoing Liver Resection

Rethinking Clinical Trials

Dr. Paul Karanicolas In this Friday’s PCT Grand Rounds, Paul Karanicolas of the University of Toronto will present “Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, November 22, 2024, at 1:00 pm eastern. Karanicolas is a professor of surgery at the University of Toronto and the Sherif and Mary-Lou Hanna Chair in Surgical Oncology Research, a joint appointment at the Sunnybrook Research

Trials 163
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Memory Is Not Confined to Our Brains, Scientists Discover

AuroBlog - Aurous Healthcare Clinical Trials blog

Mouse cortical neurons. (ALol88/Wikimedia Commons/CC by 4.0) Our brain isn’t the only place memories form in our body. New York University (NYU) researchers have discovered learning through repetition may be fundamental to all of our cells. The process may also help explain why taking breaks is such a powerful learning tool.

Scientist 201

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Health Canada issues NOC to J&J’s CARVYKTI for multiple myeloma

Pharmaceutical Technology

Health Canada has issued a Notice of Compliance (NOC) for Johnson & Johnson’s (J&J) CARVYKTI for multiple myeloma treatment.

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November 21, 2024: Are Pragmatic Trials Living Up to the Promise of Improving Representativeness?

Rethinking Clinical Trials

In a new commentary, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core explore the potential of pragmatic trials to improve demographic representativeness and health equity in clinical research. The article, “Untapped Potential? Representativeness in Pragmatic Clinical Trials,” was published online ahead of print in JAMA.

Trials 317
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Algae That Can Cause Memory Loss Found Lurking in Seafood

AuroBlog - Aurous Healthcare Clinical Trials blog

(encrier/Getty Images) The tropical waters that flow between the Philippines archipelago contribute more than four million tonnes of seafood to global markets, positioning the country as the 11th largest seafood producer in the world.

Scientist 190
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BridgeBio heart drug approved by FDA, setting up battle with Pfizer

Bio Pharma Dive

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

Drugs 271
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 

Pharmaceutical Technology

The UK’s NICE has rejected a deal for the reimbursement of Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu for the third time.

Drugs 253
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November 21, 2024: JAMA Commentary Highlights Need for Virtual Vigilance in Decentralized Clinical Trials

Rethinking Clinical Trials

In a JAMA Viewpoint published online this week , coauthors Adrian Hernandez and Chris Lindsell caution that, although the use of decentralized trials creates meaningful efficiencies, there are major threats to the validity of these trials not captured by traditional monitoring and oversight practices. In a decentralized clinical trial, some or all of the trial-related activities take place at locations other than the trial site, which can result in decrease in travel, time, and burden for patien

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Study Finds Eggs Might Protect Brain Health And Lower Cholesterol

AuroBlog - Aurous Healthcare Clinical Trials blog

(SimpleImages/Getty Images) A high-cholesterol animal product eaten by billions of people worldwide is not as bad for your health as it’s often cracked up to be. It might even be good for you.

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Flagship, Pfizer alliance yields two more startup deals

Bio Pharma Dive

Pfizer will work with Ampersand Biomedicines and Montai Therapeutics to find drugs for obesity and lung cancer, respectively, adding to collaborations it previously formed with other Flagship startups.

Drugs 288
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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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Kura Oncology partners Kyowa Kirin to advance AML treatment

Pharmaceutical Technology

Kura has partnered Kyowa Kirin in a strategic global collaboration for developing and commercialising oral ziftomenib to treat AML

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November 19, 2024: NIH Collaboratory’s Greg Simon to Receive Inaugural HCSRN Founders’ Award

Rethinking Clinical Trials

Dr. Greg Simon Greg Simon, a longtime member of the Coordinating Center leadership team for the NIH Pragmatic Trials Collaboratory, was selected by the Health Care Systems Research Network (HCSRN) Governing Board of Directors to receive the organization’s inaugural Founders’ Award. The new award recognizes individuals who best exemplify the spirit of the HCSRN’s early founders in their service and lasting contributions to the network.

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Dr. Nimmy VS of Vaidyaratnam Ayurveda College wins first prize in All India Ayurveda Thesis Competition 2024

AuroBlog - Aurous Healthcare Clinical Trials blog

Dr Nimmy VS, a faculty member of the Vaidyaratnam Ayurveda College in Thrissur, has won the first prize in the 56th All India Ayurveda Thesis Competition 2024, conducted by the Kottakkal Aryvaidyasala (KAVS) in Malappuram district in Kerala. The award carries a cash prize of Rs 60,000 and a memento. Dr.

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Biotech startups are built on venture capital. Track funding rounds here.

Bio Pharma Dive

Venture capital firms incubate, grow and finance dozens of new drug companies each year. Follow the money they channel into the industry with this database.

Drugs 274
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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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Wes Streeting says patients should view data sharing ‘the same as taxes’

Pharmaceutical Technology

UK Health Secretary Wes Streeting outlaid the key shifts needed to fix a “fragmented” NHS at the Jefferies London Healthcare Conference.

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AstraZeneca to go on defense for Andexxa as FDA questions bleeding reversal agent's safety ahead of adcomm

Fierce Pharma

As a council of outside experts prepares to meet Thursday to discuss AstraZeneca’s Andexxa, the FDA has flagged “major safety findings” linked to the British drugmaker’s bleeding reversal agent.

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Biopharma & medical devices cos view advanced infrastructure to propel manufacturing & new drug development

AuroBlog - Aurous Healthcare Clinical Trials blog

Critical infrastructure in biopharma and medical devices plays a vital role in enabling innovation, bolstering research and development, and ensuring the production of novel drugs and products. It ensures scalability, quality control, and regulatory compliance.

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CRISPR therapy from Intellia may ameliorate rare heart disorder, data suggest

Bio Pharma Dive

Phase 1 data indicate Intellia’s medicine could be a powerful treatment for a cardiac form of ATTR amyloidosis. But rival drugs are further ahead.

Medicine 288
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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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AHA 2024: Plozasiran demonstrates promising Phase III results in FCS adults

Pharmaceutical Technology

During AHA 2024, data were presented from the Phase III trial of plozasiran targeting adults with genetically or clinically diagnosed FCS,

Genetics 246
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Johnson & Johnson, Merck lay off workers in China as local headwinds take a toll

Fierce Pharma

Johnson & Johnson and Merck are laying off workers in Chi | Johnson & Johnson and Merck are laying off workers in China, according to a story from Bloomberg which cites reports from Chinese news outlets.

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‘Brain Training’ May Not Work, But There Is a Way to Boost Your Cognition

AuroBlog - Aurous Healthcare Clinical Trials blog

(Stefania Pelfini, La Waziya Photography/Getty Images) Some 2.3 million of U.S. adults over 65 – more than 4% – have a diagnosis of dementia. But even without a diagnosis, a certain amount of cognitive decline is normal as age sets in.

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Amgen picks prolific biotech founder Chang as new top scientist

Bio Pharma Dive

Howard Chang will take over as chief scientific officer and senior VP of research as the biotech searches for more ways to overcome the looming loss of exclusivity for some of its top-selling medicines.

Scientist 220
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AbbVie’s Elahere wins European approval for certain ovarian cancers

Pharmaceutical Technology

The decision in Europe follows an approval granted by the US Food and Drug Administration (FDA) in March this year.

Drugs 255
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Printable organic X-ray sensors may transform treatment for cancer patients

Medical Xpress

An international research team, led by the University of Wollongong (UOW), has found wearable organic X-ray sensors could offer safer radiotherapy protocols for cancer patients.

Research 112
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New technologies and treatments revolutionizing diabetes care: Dr Ajay Aggarwal

AuroBlog - Aurous Healthcare Clinical Trials blog

As diabetes continues to rise globally, healthcare experts are increasingly turning to innovative tools and treatments to manage the condition. Dr Ajay Aggarwal, chairperson of the Department of Endocrinology & Metabolism at Sir Ganga Ram Hospital, sheds light on the latest advancements in diabetes care and emphasizes the importance of personalized treatment strategies.

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Novartis wagers more than $1B on gene therapies for the nervous system

Bio Pharma Dive

In buying Westlake-backed Kate Therapeutics, Novartis gets a handful of preclinical gene therapies targeting diseases like Duchenne muscular dystrophy and myotonic dystrophy type 1.

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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.