Sat.Sep 21, 2024 - Fri.Sep 27, 2024

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Pancreatic cancer: The clinical trial landscape and progress for 2024 

Pharmaceutical Technology

Pancreatic cancer is resistant to conventional therapies, but cutting-edge research may improve survival rates and patient quality of life.

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Bristol Myers schizophrenia drug, the first of its kind, approved by FDA

Bio Pharma Dive

In testing, Cobenfy eased schizophrenia symptoms without some of the disruptive side effects typical of existing drugs. The results have been met with excitement, as well as caution.

Drugs 332
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These Tiny Robots Can Patch Up Deadly Bleeds in Animal Brains

AuroBlog - Aurous Healthcare Clinical Trials blog

(Wang et al., Small, 2024) Swarms of spherical nanobots barely larger than a virus could one day save hundreds of thousands of lives globally each year by staunching deadly bleeds in the brain.

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September 24, 2024: GRACE Team Identifies Barriers to Integrating Acupuncture Into US Healthcare System

Rethinking Clinical Trials

In a systematic review of the literature, researchers from the GRACE trial identified and categorized barriers and facilitators related to integrating acupuncture into the US healthcare system. The review was published online ahead of print in the Journal of Integrative and Complementary Medicine. Acupuncture is widely practiced in the United States and has been shown to be effective in multiple clinical applications for a variety of conditions.

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

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Biogen, UCB get the lupus data they’ve waited two decades for

Bio Pharma Dive

The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.

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“PBMs favour high list prices”- Novo Nordisk CEO targets PBMs in US Senate hearing

Pharmaceutical Technology

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

Insulin 312

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September 25, 2024: Randomizing Entire Countries, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Tom Lietman of the University of California, San Francisco, will present “Azithromycin for Childhood Mortality: Randomizing Entire Countries.” The Grand Rounds session will be held on Friday, September 27, 2024, at 1:00 pm eastern. Lietman is the Ruth Lee and Phillips Thygeson Distinguished Professor in the Department of Ophthalmology and the Department of Epidemiology and Biostatistics at the University of California, San Francisco, and the d

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Arch raises another $3B biotech fund in pursuit of ‘coolest’ new science

Bio Pharma Dive

Despite working in a restrictive funding climate, the prolific startup creator is “in the ‘taking lots of risk’ mode,” said co-founder and managing director Robert Nelsen.

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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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Expert Explains Why You Should Clean Your Tongue Twice a Day

AuroBlog - Aurous Healthcare Clinical Trials blog

(Science Photo Library/Getty Images) Has your doctor asked you to stick out your tongue and say “aaah”? While the GP assesses your throat, they’re also checking out your tongue, which can reveal a lot about your health. The doctor will look for any changes in the tongue’s surface or how it moves.

Doctors 199
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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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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

Marketing 135
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Novo CEO pressed by Senate to cut prices of obesity, diabetes drugs

Bio Pharma Dive

CEO Lars Fruergaard Jørgensen told lawmakers the company would consider new talks with insurers about the list prices of Wegovy and Ozempic if they pledge to keep the medicines on their formularies.

Medicine 284
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EMA CHMP recommends AstraZeneca’s Fasenra to treat EGPA

Pharmaceutical Technology

The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).

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Deadly Fungal Infections Causing a ‘Silent Pandemic’, Scientists Warn

AuroBlog - Aurous Healthcare Clinical Trials blog

(Tanja Ivanova/Getty Images) The world is in the midst of an antibiotic resistance crisis that contributes to the death of nearly 5 million people a year. But bacteria aren’t the only mutating pathogens we need to worry about.

Scientist 173
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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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Grand Rounds September 20, 2024: Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials (John Fortney, PhD)

Rethinking Clinical Trials

                      Speaker John Fortney, PhD Professor Department of Psychiatry and Behavioral Sciences University of Washington Senior Research Career Scientist HSR Center of Innovation for Veteran-Centered and Value-Driven Care VA Puget Sound Health Care System Slides Keywords Pragmatic; Implementation; Hybrid-Effectiveness; Trial Types Key Points Pragmatic trials are primarily designed to determine the effectiveness of a clinical intervention under the usual condition

Trials 130
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FDA, after delay, clears Regeneron and Sanofi drug for COPD

Bio Pharma Dive

Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.

Medicine 301
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Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services 

Pharmaceutical Technology

West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.

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Scientists Just Identified Hundreds of Genes That Could Cause Cancer

AuroBlog - Aurous Healthcare Clinical Trials blog

(Richard Jones/Science Photo Library/Getty Images) Scientists have discovered hundreds of genes that could potentially promote cancer, new research shows. Cancer is typically triggered by some kind of change to our genetic coding that interferes with a cell’s ability to manage its growth.

Scientist 173
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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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Grand Rounds June 28, 2024: Using ChatGPT to Facilitate Truly Informed Medical Consent (Fatima N. Mirza, MD, MPH)

Rethinking Clinical Trials

                      Speaker Fatima N. Mirza, MD, MPH Chief Resident Department of Dermatology Warren Alpert Medical School of Brown University Slides Keywords Artificial Intelligence; ChatGPT; Informed Consent Key Points Artificial Intelligence (AI), when implemented thoughtfully in clinical settings, can lead to meaningful results for patients.

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After setback, Biohaven to seek approval of neurological disorder drug

Bio Pharma Dive

With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.

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EC authorises LEO Pharma Anzupgo cream for chronic hand eczema

Pharmaceutical Technology

The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.

Marketing 246
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India’s bioeconomy in right direction to cross $300 billion mark by 2030: Report

AuroBlog - Aurous Healthcare Clinical Trials blog

The Association of Biotechnology Led Enterprises (ABLE) plays an intrinsic role as India’s bioeconomy propels innovation to leap towards the next phase of bio-manufacturing potential.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

Drugs 121
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An Italian biotech gets $52M to advance pediatric gene therapies

Bio Pharma Dive

The financing will support a technology designed to make delivery of lentiviral gene therapies, which are typically administered through a complex process, more convenient.

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Pharmaceutical Packaging Companies in Contract Manufacturing for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading Pharmaceutical Packaging Companies, Suppliers & Solutions. Download the free Buyer's Guide today for full details.

Packaging 239
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PvPI and ADR monitoring & reporting should be made part of pharmacy curriculum: Dr B Suresh

AuroBlog - Aurous Healthcare Clinical Trials blog

Since the Pharmacovigilance Programme of India (PvPI) is taking momentum in the health sector today, the PvPI and the Adverse Drug Reaction (ADR) monitoring and reporting should be made part of the curriculum of the pharmacy education.

Pharmacy 151
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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.

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Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

Fierce Pharma

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.

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Pfizer to pull sickle cell drug from market, shut down trials

Bio Pharma Dive

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S. in 2019.

Trials 275
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BMS wins approval for schizophrenia drug acquired from Karuna

Pharmaceutical Technology

The FDA has approved the first treatment for schizophrenia that targets cholinergic receptors rather than dopamine receptors.

Drugs 246
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MCura revolutionizing OPD value chain for patient safety through digital initiatives: Madhubala Radhakrishnan

AuroBlog - Aurous Healthcare Clinical Trials blog

Healthcare technology company MCura is transforming outpatient department (OPD) services across India through its innovative digital solutions aimed at improving patient safety, medication adherence, and overall treatment transparency.

Drugs 142
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.