Sat.Apr 27, 2024 - Fri.May 03, 2024

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What’s Next for Obesity Therapeutics? Higher Quality Weight Loss

BioSpace

With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.

Drugs 117
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From banking to biotech - Renée Aguiar-Lucander's unique path in science

BioPharma Reporter

RenÃe Aguiar-Lucander, CEO of Calliditas, is driving the advancement and launch of TARPEYO â the companyâs medication targeting rare disease IgA nephropathy. We spoke with RenÃe about her journey from investment banking to science and the joy of bringing therapies to patients.

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California to sell state-branded Narcan generic to cut costs

pharmaphorum

California will start selling its own generic of overdose reversal agent naloxone in another example of the use of government-level purchasing power to reduce drug prices

Branding 114
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Breakthrough: Rare Gene Mutation Offers Clues to Preventing Type 1 Diabetes

AuroBlog - Aurous Healthcare Clinical Trials blog

A unique genetic mutation in two siblings – that has never been seen in anyone else – has been discovered by UK researchers at the University of Exeter, pointing the way towards new treatment options for type 1 diabetes.

Gene 178
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Cell and gene therapy companies trip at scalability hurdle

Pharmaceutical Technology

Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.

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FDA defends lab test rule, as critics fear industry upheaval

Bio Pharma Dive

The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burden could slow access to testing.

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Study reveals vitamin D-altered mouse gut bacteria provides better cancer immunity

Pharma Times

Bacteroides fragilis in the gut improves immunity and immunotherapy treatment responses

Bacteria 118
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The Day the Electronic Medical Records System Went Down

JAMA Internal Medicine

This essay describes the author’s experience of improved patient care and collaboration the day the the electronic medical records system went down.

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UK health offers course for professionals to learn from the forefront of psychedelic research hub

Outsourcing Pharma

Clerkenwell Health is proud to announce the launch of its foundation course for Psychedelic-Assisted Therapy, a comprehensive 30-hour program that brings together leading experts in the field.

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AstraZeneca admits Covid-19 vaccine may cause blood clots in “very rare” cases

Pharmaceutical Technology

AstraZeneca has maintained that while the vaccine may, in “very rare” cases, cause TTS, the casual mechanism for this effect remains unknown.

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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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CG follows big IPO with new results for bladder cancer drug

Bio Pharma Dive

Newly disclosed Phase 3 results presented Friday match findings the biotech disclosed last year, while offering a more comprehensive look at how its drug stacks up to rival therapies.

Drugs 306
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Florida Man’s Mystery Migraine Traced to Rare Case of Parasite in His Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

A 52-year-old Florida man presented to hospital with complaints that his usual migraines had worsened over the past four months. On closer inspection using a CT scan, the doctors discovered his severe headaches were the result of several cysts throughout his brain.

Doctors 190
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Navigating Varying Regulatory Feedback in Clinical Oncology Trials: A Guide for Clinical Research Professionals

Worldwide Clinical Trials

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge. For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations.

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ESCMID 2024: Using AI in infection prevention and control

Pharmaceutical Technology

Artificial intelligence tools can be used for infection control through facial recognition systems designed to identify proper face mask use within hospitals.

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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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Reunion raises over $100M to build a better psychedelic drug

Bio Pharma Dive

The funding will help Reunion pay for a mid-stage study testing its most advanced medicine — essentially a synthetic version of the hallucinogenic psilocin — in women with postpartum depression.

Medicine 300
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Breakthrough Vaccine Shows High Protection Against Drug-Resistant Superbug in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have developed a vaccine against a notorious drug-resistant superbug, targeting molecules on its surface that are also found on other bacteria and fungi.

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May 1, 2024: PKIDS Pragmatic Trial to Be Featured in PCT Grand Rounds

Rethinking Clinical Trials

Dr. Gregory Tasian In this Friday’s PCT Grand Rounds, Gregory Tasian of the Children’s Hospital of Philadelphia will present “Comparative Effectiveness of Kidney Stone Surgery in Pediatric Patients: The PKIDS Trial.” The Grand Rounds session will be held on Friday, May 3, 2024, at 1:00 pm eastern. The Pediatric Kidney Stone (PKIDS) Care Improvement Network Trial is a patient-centered, pragmatic clinical trial comparing the effectiveness of stone clearance for 3 surgical m

Trials 147
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The top pharmaceutical companies by R&D expenditure

Pharmaceutical Technology

From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.

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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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Delphia starts up with $67M to make a new type of cancer drug

Bio Pharma Dive

Delphia is developing medicines designed to overstress certain cellular pathways to the point tumor cells die, an approach the biotech calls “activation lethality.

Medicine 298
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CDSCO releases draft guidance document on stability studies of IVD Medical Devices

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.

In-Vitro 172
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5 Mid-Stage ALS Drugs to Watch

BioSpace

As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.

Drugs 138
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Angle signs AstraZeneca deal to develop prostate cancer assay

Pharmaceutical Technology

UK liquid biopsy company, Angle, has agreed a supplier agreement with AstraZeneca to develop a Parsotix-based Androgen Receptor (AR) assay for use in prostate cancer studies.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Enlaza gets JP Morgan, Regeneron backing for covalent biologics

Bio Pharma Dive

The funds will help the cancer-focused startup Enlaza bring “several development candidates” towards human testing in the next few years, its CEO said.

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Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports

AuroBlog - Aurous Healthcare Clinical Trials blog

Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).

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Prevention revolution: How digital tools can help us get ahead of health problems

pharmaphorum

Discover how digital tools can provide insights to help us. Digital technology could be a game-changer that offers the elusive promise of tackling the root cause, not just the conditions themselves, when it comes to human health.

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ESCMID 2024: The infectious consequences of climate change

Pharmaceutical Technology

Dengue fever is now found in over 120 countries compared to nine that experienced severe epidemics in the 1970s given the spread of infectious diseases due to climate change.

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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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GSK raises forecasts on strong vaccine, HIV drug sales

Bio Pharma Dive

Sales of the shingles vaccine Shingrix and the RSV shot Arexvy helped fuel quarterly revenue totals that surpassed analyst expectations, though the company warned momentum could slow in the months ahead.

Sales 286
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Common Blood Pressure Drug Increases Lifespan And Slows Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Previous research has shown rilmenidine mimics the effects of caloric restriction on a cellular level.

Drugs 163
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Pace, acceleration, and precision are the name of the game

pharmaphorum

Security and privacy within biotech are critical points of consideration and discussion as the industry continues to innovate at speed, and it is such aspects that are central to today’s podcast with Zach Powers, chief information security officer at Benchling, the R&D cloud platform for the biotech industry.

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FDA grants RMAT designation to Taysha’s Rett syndrome gene therapy 

Pharmaceutical Technology

The FDA has awarded the designation following a review of initial safety and efficacy data from two Phase I/II clinical trials.

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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.