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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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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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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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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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 255
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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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The link between headache disorders and suicide—a 25-year Danish cohort study

Medical Xpress

New evidence from a large population-based cohort analysis indicates an increased risk of both attempted and completed suicide among individuals diagnosed with headache disorders. Researchers at Aarhus University in Denmark found that individuals diagnosed with migraine, tension-type headache, posttraumatic headache, and trigeminal autonomic cephalalgia face an increased risk of suicide.

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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 205
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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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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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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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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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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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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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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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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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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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 189
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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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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.

Drugs 205
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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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‘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 182
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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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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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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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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 182
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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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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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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 132
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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 173
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Capgemini unveils AI breakthrough to boost bioeconomy

Pharma Times

New methodology may boost innovation in protein engineering

Engineer 133
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EU reshapes HTAs: is the industry ready for it?

Pharmaceutical Technology

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

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Clot-busting meds may be effective up to 24 hours after initial stroke symptoms

Medical Xpress

The clot-dissolving medication, alteplase, improved stroke patients' recovery by more than 50% when given up to 24 hours after the beginning of an ischemic stroke, according to preliminary late-breaking science presented today at the American Stroke Association's International Stroke Conference 2025. The conference, in Los Angeles, Feb. 5-7, 2025, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

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Pliant shares collapse as company halts fibrosis drug study

Bio Pharma Dive

In what one analyst called a “unique situation,” the company stopped dosing patients on the recommendation of trial monitors, but doesn’t yet know what led to their decision.

Drugs 173
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Illuccix therapy gets approval in the UK

Pharma Times

Imaging agent to improve prostate cancer detection

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Eton secures US patent for diabetes insipidus treatment

Pharmaceutical Technology

Eton has secured a patent from the USPTO for its ET-600 product candidates desmopressin oral solution formulation for diabetes insipidus.