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 240
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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 157
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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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How to Turn “Check-the-Box” Compliance Trainings Into Real Learning

Speaker: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group

Let’s face it—most ethics and compliance trainings aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, relevant, and maybe even enjoyable! Join expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training programs. You’ll discover creative strategies to turn traditionally dry topics into meaningful learning experiences that resonate and drive real change.

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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 173
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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.

More Trending

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First To Know Syphilis Test Offers At-Home Diagnosis in 15 Minutes

XTalks

Traditional syphilis testing often requires clinic or lab visits, posing challenges for individuals seeking privacy or with limited healthcare access. NOWDiagnostics’ First To Know Syphilis Test circumvents these barriers with a convenient, in-home solution offering results in just 15 minutes. The test, the first of its kind approved for over-the-counter (OTC) use in the US, detects antibodies for Treponema pallidum , the bacterium responsible for syphilis.

Bacterium 104
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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 316
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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 264
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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 307
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Clinical Research White Paper – Enhancing Transparency & Efficiency Throughout the Trial Lifecycle

Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness

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Ultromics’ EchoGo Amyloidosis Tackles Cardiac Amyloidosis Underdiagnosis with AI

XTalks

The US Food and Drug Administration (FDA) has granted Breakthrough Device clearance to Ultromics’ EchoGo Amyloidosis device through its Total Product Lifecycle Advisory Program (TAP). Cardiac amyloidosis, a serious and often underdiagnosed heart condition, poses significant diagnostic challenges even for experienced clinicians. It is characterized by the build-up of abnormal protein deposits in the heart tissue, leading to stiffening of the heart walls and impairing its ability to pump blood eff

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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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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 257
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Versant startup sets out to make a new type of obesity drug

Bio Pharma Dive

The startup, Pep2Tango, is combining four methods of accelerating weight loss into one medicine in the hopes of developing a treatment that can improve upon drugs like Wegovy and Zepbound.

Drugs 307
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Tirzepatide gets a big win in obesity-related heart failure

pharmaphorum

Eli Lilly's tirzepatide has been shown to significantly cut cardiovascular risks in patients with obesity and a form of heart failure with few treatment options, in another big win for the GLP-1 receptor agonist class.The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly's drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.

Trials 97
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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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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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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 293
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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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Diversity Action Plans (DAPs) in Clinical Trials Are No Longer a “Nice-to-Have” — Are You Ready?

XTalks

In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinical trial outcomes. The integration of diverse patient populations ensures that therapeutic interventions are effective across different demographics, reflecting real-world settings. The need for adequate representation has given rise to several initiatives, the most notable and recent among which is the US Food and Drug Administration

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ICMR invites bids for advanced online intellectual property management software

AuroBlog - Aurous Healthcare Clinical Trials blog

In a move to streamline its growing intellectual property (IP) management needs, the Indian Council of Medical Research (ICMR) has issued an Expression of Interest (EOI) for the procurement of an online intellectual property management software. Technical proposals must be submitted by November 22, 2024, by 9:00 am.

Research 187
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“No magic wand” for Novo Nordisk, as CagriSema pen supply rumours swirl

Pharmaceutical Technology

Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.

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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 292
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Can Your Organization Spot a Conflict Before It’s a Crisis?

Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk

In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?

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Cloudbyz Recognized in Everest Group’s 2024 PEAK Matrix® for Life Sciences CTMS Solution

Cloudbyz

Cloudbyz Achieves Key Recognition in Everest Group’s 2024 PEAK Matrix® for Life Sciences Clinical Trial Management System (CTMS) Products Naperville, IL, November 22, 2024 – Cloudbyz, a leader in cloud-based clinical trial management solutions, proudly announces its recognition in the 2024 Everest Group PEAK Matrix® for Life Sciences Clinical Trial Management System (CTMS) solutions.

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New PAGB research highlights importance of self-care for easy-to-treat conditions

Pharma Times

The census found that 56% of people visit their GP for a UTI and 27% for thrush

Research 134
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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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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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White Paper - A Roadmap to AI Data Readiness in R&D Labs

Download this comprehensive guide to AI and ML in the R&D Laboratory Setting.

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One of the ASCRT Program’s Earliest Recipients Goes the Distance

ACRP blog

A scholarship powered by the long-distance cycling adventures of some of the ACRP Community’s greatest equity champions and their backers has gone the distance on the other side of the globe this year, resulting in a completed prostate cancer project for Esther Samuel in Nigeria, who was among the initial recipients of ACRP Access for Students to Clinical Research Training (ASCRT) program support.

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Ardena’s expanded nanomedicine facility granted full GMP approval

Pharma Times

The Netherlands facility is designed to handle a wide range of nanomedicines, including lipid-based nanoparticles

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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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Lexicon to disband sales team, lay off 60% of staff

Bio Pharma Dive

The restructuring follows the company's receipt of a letter from the FDA citing "deficiencies" in its approval application for diabetes drug Zynquista.

Sales 261
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model