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 101
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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 110
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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 189
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 113
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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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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 271
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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 172
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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 141
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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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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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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 182
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Funding Rehab: Knowing Your Options

Pharma Mirror

Addiction is affecting a large portion of people’s lives at the minute, but one of the things people often struggle with is knowing how to afford rehab. There’s a common misconception that it costs thousands upon thousands of pounds and is entirely unattainable for people in some circles of society. However, that’s precisely what it is, a misconception, and many options can help people, no matter how wealthy or poor they are.

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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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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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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 249
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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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Walmart retreats from healthcare, closing clinics across US

pharmaphorum

For the last few years, Walmart has been promising to disrupt the US healthcare sector with a national network of clinics providing low-cost care and telehealth services. Now, it is reining back on those plans.

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Eli Lilly reports 67% increase in Q1 2024 net income

Pharmaceutical Technology

Eli Lilly has announced that its net income rose to $2.24bn in Q1 2024, a 67% increase from $1.34bn in the same period of 2023.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Pfizer’s strong Vyndaqel sales draw attention to rare disease drug’s patent life

Bio Pharma Dive

Sales of the transthyretin amyloidosis treatment widely beat Wall Street forecasts in the first quarter. The company aims to extend its patent exclusivity.

Sales 280
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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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Pfizer sets up DTC marketing platform as Q1 sales beat expectations

Fierce Pharma

Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. | Following the lead of Eli Lilly, Pfizer will establish a direct-to-consumer service, selling some of its medicines online and avoiding industry middlemen. The company plans to sell products such as its COVID treatment Paxlovid and a migraine nasal spray in this way, it told the Financial Times.

Sales 110
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Pfizer receives FDA approval for haemophilia B gene therapy

Pharmaceutical Technology

Pfizer has received approval from the US Food and Drug Administration (FDA) for its one-time gene therapy BEQVEZ for haemophilia B.

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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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Lilly hikes revenue forecast by $2B as GLP-1 drug sales climb

Bio Pharma Dive

Supply continues to be tight, however, and the company anticipates further sales growth to be limited by how quickly it can bring on additional production capacity.

Sales 281
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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 141
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Insights from the 18th Annual Canadian Summit on Food Safety in 2024

XTalks

The 18th Annual Canadian Summit on Food Safety , held last week, brought together industry leaders, regulatory experts and innovators to discuss the current state and future of food safety. The event spanned two days packed with keynote speeches, panel discussions and networking opportunities aimed at enhancing food safety practices across the country.

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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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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.