BioSpace
APRIL 28, 2024
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.
BioPharma Reporter
MAY 1, 2024
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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pharmaphorum
APRIL 30, 2024
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
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
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.
Pharmaceutical Technology
APRIL 29, 2024
Experts hold scalability challenges and high costs accountable for market failures within the cell and gene therapy landscape.
Bio Pharma Dive
APRIL 30, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
MAY 2, 2024
Bacteroides fragilis in the gut improves immunity and immunotherapy treatment responses
JAMA Internal Medicine
APRIL 28, 2024
This essay describes the author’s experience of improved patient care and collaboration the day the the electronic medical records system went down.
Outsourcing Pharma
MAY 2, 2024
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.
Pharmaceutical Technology
MAY 1, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
MAY 3, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 30, 2024
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.
Rethinking Clinical Trials
MAY 1, 2024
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
Pharmaceutical Technology
APRIL 28, 2024
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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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.
Bio Pharma Dive
MAY 2, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 1, 2024
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.
BioSpace
APRIL 28, 2024
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.
Pharmaceutical Technology
MAY 2, 2024
From Merck & Co to Sanofi, Pharmaceutical Technology lists the leading pharmaceutical companies spending the most on R&D in 2023.
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.
Bio Pharma Dive
MAY 2, 2024
Delphia is developing medicines designed to overstress certain cellular pathways to the point tumor cells die, an approach the biotech calls “activation lethality.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 30, 2024
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.
Fierce Pharma
APRIL 30, 2024
The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. | The U.S. FTC is not done with its crackdown on what it views as improper listing of patents in the FDA Orange Book. After an initial round of challenge launched in November against more than 100 patents, the FTC is back targeting another 300-plus patent listings by eight pharma firms.
Pharmaceutical Technology
MAY 3, 2024
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.
Bio Pharma Dive
APRIL 30, 2024
The funds will help the cancer-focused startup Enlaza bring “several development candidates” towards human testing in the next few years, its CEO said.
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
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).
Fierce Pharma
APRIL 30, 2024
Biopharma companies and industry lobbying groups are striking out in their legal efforts to challenge price-cutting measures in the Inflation Reduction Act. | A federal judge tossed lawsuits by Bristol Myers Squibb and Johnson & Johnson, which questioned the constitutionality of the U.S. government requiring drugmakers to negotiate with Medicare on drug pricing.
Pharmaceutical Technology
APRIL 30, 2024
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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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.
Bio Pharma Dive
MAY 1, 2024
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 2, 2024
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.
Fierce Pharma
MAY 1, 2024
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.
Pharmaceutical Technology
MAY 3, 2024
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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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.
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