AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 26, 2025
Breast cancer cases in the US among women aged under 40 are jumping up by nearly half a percent each year, though new research by scientists at Columbia University suggests the rise isn’t spread evenly across the country.
Bio Pharma Dive
FEBRUARY 24, 2025
Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.
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Pharmaceutical Technology
FEBRUARY 24, 2025
With Novo Nordisks blockbuster drugs Wegovy and Ozempic back in stock, copycat versions are no longer allowed for now.
Rethinking Clinical Trials
FEBRUARY 24, 2025
Updated study snapshots and ethics and regulatory documentation are now available for the AIM-CP, ARBOR-Telehealth, and RAMP trials. The 3 NIH Collaboratory Trials, all supported through the NIH HEAL Initiative, or Helping to End Addiction Long-Term Initiative, reflect a special emphasis on developing strategies for the management of chronic pain in rural and remote populations. “There are many known disparities between urban and rural populations,” said Karen Kehl, a program directo
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
FDA Law Blog
FEBRUARY 27, 2025
By Julie Kim & Deborah L. Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).
Bio Pharma Dive
FEBRUARY 25, 2025
Ten of 11 children born with a rare form of congenital hearing loss experienced improvements after receiving the company’s treatment, new data show.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
FEBRUARY 25, 2025
Texas Childrens Hospital and The University of Texas MD Anderson Cancer Center have announced a collaboration dedicated to fighting childhood cancer. The first-of-its-kind joint venture, approved by both the Texas Childrens Board of Trustees and the UT System Board of Regents, marks a historic step toward building what leaders are calling the worlds preeminent pediatric cancer center.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 23, 2025
Artist’s impression of a planetary alignment event, not to scale. (buradaki/Getty Images) A very rare treat is about to grace Earth’s night skies.
Bio Pharma Dive
FEBRUARY 25, 2025
Telehealth provider Hims & Hers said it will tell consumers they need to seek “alternative options on the commercial dosing,” but in earnings Monday still forecast higher revenue and profits in 2025.
Pharmaceutical Technology
FEBRUARY 25, 2025
Samsung Bioepis has now allegedly sub-licensed its Stelara biosimilar rights to a health conglomerate, breaching a previous settlement.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
XTalks
FEBRUARY 28, 2025
Medtronic has received FDA approval for its BrainSense Adaptive Deep Brain Stimulation (aDBS) system. Medtronic says the technology represents the worlds first closed-loop deep brain stimulation (DBS), brain-computer interface (BCI) technology that adjusts therapy in real-time based on an individuals brain activity, offering a more personalized approach to managing Parkinsons symptoms.
ACRP blog
FEBRUARY 25, 2025
[ Editors Note: In recognition of Rare Disease Day being observed on February 28, ACRP is pleased to present this, the second of two blogs contributed by subject matter experts offering insights on how rare diseases are being focused on by the clinical research enterprise. The first blog highlights how Net Treatment Benefit assessments may be used to support rare disease research. ] Randomized controlled clinical trials are considered the gold standard for understanding treatment safety and eff
Bio Pharma Dive
FEBRUARY 27, 2025
The meeting, which helps the FDA give guidance to vaccine makers on which flu strains to target, is the second to be disrupted since Robert F. Kennedy Jr. was sworn in as health secretary.
Pharmaceutical Technology
FEBRUARY 24, 2025
PHARMAP 2025 takes place on 14-15 April 2025 in Berlin, Germany.
XTalks
FEBRUARY 25, 2025
A recent survey by 9amHealth has revealed a significant trend in employee health benefits: employer-sponsored GLP-1 drug coverage is emerging as a pivotal factor in attracting and retaining top talent. As the competitive landscape for skilled professionals intensifies, companies are re-evaluating their health benefits packages to include innovative treatments that go beyond traditional healthcare offerings.
Pharma Times
FEBRUARY 26, 2025
Updated data from phase 2 study reveals survival benefit
Bio Pharma Dive
FEBRUARY 24, 2025
An industry source said “most, if not all” of the people at CDRH who were recently dismissed are now being asked to return.
Pharmaceutical Technology
FEBRUARY 26, 2025
Eikons lead candidate EIK1001 is being investigated for melanoma in combination with MSDs Keytruda in a Phase III trial.
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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
XTalks
FEBRUARY 28, 2025
Eli Lilly has announced it is slashing the price of Zepbound (tirzepatide) its hugely popular GLP-1/GIP-1 weight-loss medication and is introducing higher-dose vials of it. The initiative aims to provide more affordable options for patients paying out-of-pocket and to counter the growing market of compounded versions of weight-loss drugs. Eli Lilly has unveiled 7.5 mg and 10 mg single-dose vials of Zepbound, each priced at $499 for a months supply when refilled within 45 days through Lillys ne
pharmaphorum
FEBRUARY 25, 2025
Ten out of 11 children with congenital deafness treated with a gene therapy developed by Regeneron have seen "notable" improvements in hearing
Bio Pharma Dive
FEBRUARY 24, 2025
Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.
Pharmaceutical Technology
FEBRUARY 24, 2025
In an anonymous post in the BMJ, the author claims that words relating to DEI could lead to grants being taken away.
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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.
XTalks
FEBRUARY 25, 2025
Mirum Pharmaceuticals, a biotech innovator known for developing therapies for rare metabolic disorders, now has FDA approval for its new treatment, Ctexli (chenodiol) tablets the first and only medication approved for cerebrotendinous xanthomatosis (CTX) in adults. CTX is a rare, progressive genetic disorder caused by mutations in the CYP27A1 gene, which disrupts the livers ability to produce chenodeoxycholic acid, a bile acid.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 24, 2025
Bio Asia, Asia’s premier life sciences and health tech forum, has a line-up of inspirational speakers and industry luminaries to ignite a discussion with participating leaders, MSMEs and start-ups to inspire and make India an undisputed leader in the life sciences space.
Bio Pharma Dive
FEBRUARY 28, 2025
European regulators “reaffirmed” a positive view of Eisai and Biogen’s Alzheimer’s drug after conducting a new safety review.
Pharmaceutical Technology
FEBRUARY 24, 2025
MeiraGTxs investigational gene therapy AAV-AIPL1 has improved the sight of 11 children who were born blind.
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.
pharmaphorum
FEBRUARY 27, 2025
An FDA advisory committee due to be held in March to discuss the formulation of influenza vaccines for the 2025/26 flu season has been cancelled.
Medical Xpress
FEBRUARY 28, 2025
Neuroblastoma is a solid tumor that occurs in children. When high-risk, the disease has a poor prognosis. Decades ago, adding the drug retinoic acid to neuroblastoma treatment increased survival by 1015%. However, this effect was only evident in post-chemotherapy consolidation after bulky primary tumors had largely been eliminated. Why retinoic acid is effective in this setting but not against primary tumors, has been speculated about for nearly 50 years.
Bio Pharma Dive
FEBRUARY 24, 2025
The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially landscape-changing combinations.
Pharmaceutical Technology
FEBRUARY 25, 2025
Gilead Sciences has announced EMA validation for a parallel accelerated review of lenacapavirs MAA and EU-M4all applications.
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