Sat.Feb 08, 2025 - Fri.Feb 14, 2025

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Radical Study Proposes a Single Cause to Explain Alzheimer’s Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

(koto_feja/E+/Getty Images) A new model of Alzheimer’s disease has been proposed, which could speed up efforts to understand and cure the complex condition while bringing all manifestations of the condition under one unifying theory.

RNA 195
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February 12, 2025: Results of ACP PEACE, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).” The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.

Trials 146
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Brain cells mimic muscle signaling to enhance learning and memory

Medical Xpress

New research details the subcellular structures in neurons that enable signals to be transmitted from where they are received at specific sites on dendrites to the decision-making cell body located hundreds of micrometers away. The new research finds that the endoplasmic reticulum and the plasma membrane form contact sites where specialized molecules control the release of calcium, which regulates the signals sent along the dendrite to the soma.

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FDA approves Gomekli as first neurofibromatosis drug for adults

Pharmaceutical Technology

Merck acquisition target SpringWorks will go toe-to-toe with AstraZeneca in the US neurofibromatosis market.

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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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AbbVie, Pfizer gain FDA OK for novel antibiotic

Bio Pharma Dive

The drug is cleared to treat complicated intra-abdominal infections, including those caused by tough-to-control, gram-negative bacteria.

Bacteria 248
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Panel recommends developing comprehensive long-term strategic plan for mental healthcare and research

AuroBlog - Aurous Healthcare Clinical Trials blog

Identifying a significant gap in the Ministry’s actions in addressing the funding and resource challenges in the premier mental health institutions, the Department-Related Parliamentary Standing Committee on Health and Family Welfare has recommended various measures including development of a comprehensive long-term strategic plan for mental healthcare, research and infrastructure development.

More Trending

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Novartis signs agreement to acquire Anthos for $925m upfront

Pharmaceutical Technology

Novartis has agreed to acquire Anthos Therapeutics, a Boston-based clinical-stage biopharmaceutical company, for an upfront payment of $925m.

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New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings

Bio Pharma Dive

A small semaglutide trial suggests the medicine's suppression of appetite may extend to alcohol, but larger tests are needed to establish a conclusive benefit.

Medicine 196
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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

By Lisa M. Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).

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Can a Supplement Really Help You Control Your Pesky Eye Floaters?

AuroBlog - Aurous Healthcare Clinical Trials blog

(Filipp Romanovski/Unsplash) If you look up at the sky on a clear day, you might notice little cobweb-like structures drifting across your field of vision.

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

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Obesity market to reach $173.5 billion by 2031

Pharmaceutical Technology

Given the number of comorbidities associated with obesity, the market's growth will impact the entire cardiometabolic disease space.

Marketing 255
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A brain biotech launches with Roche’s spare parts

Bio Pharma Dive

Backed by Goldman Sachs, Novo Nordisk’s parent company and others, Newleos Therapeutics debuted Thursday with $94 million and a plan to develop drugs for brain function and health.

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LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance

XTalks

LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. The FDA has set a prescription drug user fee act (PDUFA) target action date of December 12, 2025, and currently does not plan to hold an advisory committee meeting regarding the application.

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There’s Never Been a More Dangerous Time to Use Street Drugs. Here’s Why

AuroBlog - Aurous Healthcare Clinical Trials blog

In the early hours of September 14 2021, three men parked in a quiet car park in the southern English market town of Abingdon-on-Thames. The men, returning from a night out, had pulled over to smoke heroin.

Drugs 147
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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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Fourth person receives eGenesis’ gene-edited pig kidney transplant

Pharmaceutical Technology

Tim Andrews underwent the procedure with the pig kidney as part of a three-person compassionate use study.

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Axsome secures top drug’s future with Teva patent settlement

Bio Pharma Dive

Shares in the brain drug developer rose by more than 20% Monday on news of the deal, which will forestall Teva's generic copy of Auvelity from entering the U.S. market until at least 2038.

Marketing 180
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Research shows sotagliflozin is the first medication of its kind to significantly reduce both heart attacks and strokes

Medical Xpress

Sotagliflozin, a drug recently approved by the Food and Drug Administration to treat type 2 diabetes and kidney disease with additional cardiovascular risk factors, can significantly reduce heart attack and stroke among these patients, according to results from an international clinical trial led by a Mount Sinai researcher.

Research 139
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India needs to develop strategies to mitigate the impact of USAID funding freeze

AuroBlog - Aurous Healthcare Clinical Trials blog

Indian pharmaceutical industry plays a crucial role in the global drug supply chain, particularly in the US. Yet India needs to develop strategies to mitigate the impact of USAID funding freeze for Indian pharma companies.

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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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Super Bowl ad for copycat weight loss drugs stokes pharma power debate

Pharmaceutical Technology

Controversy surrounded Him & Hers commercial, called Sick of the System, in the lead up to Americas biggest sporting event.

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‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public

Bio Pharma Dive

Speaking this week at BIO CEO, the heads of Septerna, Upstream Bio and Actuate Therapeutics shared lessons from going public in a challenging market for biotech stocks.

Marketing 173
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Project Management Workshop Hones Skills: Core Competencies are Useful for All Roles

ACRP blog

People who are entering the clinical research profession can come from many other fields and with very diverse backgrounds. No matter their role, everyone acknowledges project management as an essential and invaluable skill set. Project management requires leadership, communication, and management skills that can be applied in any role across clinical research.

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Scientists peel away the mystery of JAK enzymes, which play roles in everything from eczema to ulcerative colitis

Medical Xpress

Pharmaceutical ads are difficult to avoid in American television programming and a growing number of them promote a class of medications called JAK inhibitors, using an acronym that assumes the average TV watcher knows exactly what JAK stands for.

Scientist 139
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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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WHO and St Jude start distributing paediatric cancer medicines amid US aid cuts

Pharmaceutical Technology

The World Health Organization and St Jude Children's Research Hospital have kicked off a programme to distribute cancer medicines to LMICs.

Medicine 200
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Novartis pays $925M to reel in a startup it helped launch

Bio Pharma Dive

The acquisition of Anthos Therapeutics could be worth up to $3.1 billion and returns to Novartis a blood thinner it licensed to the Blackstone-backed startup six years ago.

Licensing 173
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Delivering Compassionate Care Can Transform Lives in Clinical Research

ACRP blog

Many times, individuals who have triumphed over frightening, or even near-death, situations will say that the experience has given them a new and more positive outlook on life. Allison Massari, a two-time survivor of such scenarios, has an additional and unique insightand its on the patient experience. She celebrates how healthcare professionals have an exceptional power to transform lives, and will share her perspective on how compassionate care can be incorporated into clinical research in a S

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Mitochondria's role in diabetes: Could reversing damage offer a cure?

Medical Xpress

Mitochondria are essential for generating energy that fuels cells and helps them function.

Research 138
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Newleos secures $93.5m for neuropsychiatric treatments

Pharmaceutical Technology

Newleos has closed an oversubscribed Series A financing round, raising $93.5m to revolutionise neuropsychiatric disorder treatments.

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Aardvark prices $94M IPO to fund Prader-Willi, obesity drug work

Bio Pharma Dive

Proceeds will support testing of drugs designed to suppress hunger in people with the tough-to-treat rare disease and, potentially, more common obesity-related conditions.

Drugs 164
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Hemgenix shows efficacy among haemophilia B patients

Pharma Times

CSL Behring's study reveals significant long-term benefits

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New Strain of Bird Flu in Nevada Reveals a Concerning Mutation

AuroBlog - Aurous Healthcare Clinical Trials blog

(Dusty Pixel photography/Getty Images) An emerging strain of highly pathogenic avian influenza has spilled over from wild birds to dairy cows in the state of Nevada, and officials at the US Department of Agriculture (USDA) and some scientists are concerned by a mutation they are seeing. The viral variant, called genotype D1.

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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.