AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 28, 2025
A type of Trema micrantha. (Daniel Pineda Vera/iNaturalist/CC BY 4.0) Scientists have discovered cannabidiol, a compound in cannabis known as CBD, in a common Brazilian plant, opening potential new avenues to produce the increasingly popular substance.
Bio Pharma Dive
JANUARY 30, 2025
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a major hangup for insurers, potentially limiting patients’ ability to access it.
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Rethinking Clinical Trials
JANUARY 29, 2025
In this Friday’s PCT Grand Rounds, Richard Skolasky and Kevin McLaughlin of Johns Hopkins University will present “Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned.” The Grand Rounds session will be held on Friday, January 31, 2025, at 1:00 pm eastern. ARBOR-Telehealth, an NIH Collaboratory Trial, is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clini
FDA Law Blog
JANUARY 30, 2025
By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). That post largely focused on endpoints as well as the broader context for when accelerated approval is appropriate. However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
Pharmaceutical Technology
JANUARY 31, 2025
The FDA has approved Vertex Pharmaceuticals oral Journavx (suzetrigine) to treat adults with moderate-to-severe acute pain.
Bio Pharma Dive
JANUARY 28, 2025
The startup says its specially constructed RNAi therapies can get deep into brain tissue, yielding new ways to treat neurological conditions like Huntington’s.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
JANUARY 29, 2025
The Hidden Costs Behind Your Generic Medications: What's Driving the Price? As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. But the truth is, there's more to it than meets the eye. The cost of producing generic drugs is influenced by a multitude of factors, and understanding these dynamics can help us better appreciate the affordability of these e
Pharmaceutical Technology
JANUARY 31, 2025
Sanofi has announced an increase in net income from continuing operations for the fourth quarter (Q4) of 2024, reaching 880m ($833m).
Bio Pharma Dive
JANUARY 31, 2025
After decades of research, Vertex Pharmaceuticals now has an approved pain medication. Can one of the world’s most powerful biotechs contend with a healthcare system that’s long favored opioids?
XTalks
JANUARY 29, 2025
The FDA has approved a new dosing regimen for Biogen and Eisais Leqembi (lecanemab-irmb), introducing once-every-four-weeks intravenous (IV) maintenance dosing for patients with early Alzheimers disease. Patients can transition to the monthly dose after completing 18 months of biweekly infusions. The new dosing regimen aims to maintain the therapys benefits while improving convenience for patients and caregivers.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Medical Xpress
JANUARY 31, 2025
A new study from Moffitt Cancer Center could help doctors predict how well patients with a specific type of lung cancer will respond to new therapies. The research, published in Clinical Cancer Research, found that measuring the interaction between two proteins, RAS and RAF, could provide valuable insights into the effectiveness of treatments for patients with KRASG12C-mutant non-small cell lung cancer, a type of lung cancer known for being particularly difficult to treat.
Pharmaceutical Technology
JANUARY 27, 2025
Biohaven, acquired by Pfizer in 2022, allegedly took doctors to high-end restaurants and paid speaker honoraria for preferential prescriptions.
Bio Pharma Dive
JANUARY 28, 2025
The clearance is a step forward in AstraZeneca and Daiichi Sankyo’s plan to position antibody-drug conjugates like Enhertu ahead of chemotherapy in a variety of tumors.
XTalks
JANUARY 29, 2025
Eli Lilly launched a 75-second TV commercial called Change in November 2024 to promote the companys GLP-1 obesity drug Zepbound (tirzepatide). The Zepbound TV commercial highlights the transformative journey of weight loss, encouraging viewers to embrace change and consider Zepbound as a catalyst for achieving their health goals. The ad focuses on the theme of change to resonate with individuals seeking a meaningful and lasting impact on their health.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
Drug Patent Watch
JANUARY 30, 2025
Maximizing Patent Protection: Strategies for Pharmaceutical Marketers As a pharmaceutical marketer, you know how crucial it is to protect your patented drug's market share. But with the ever-changing landscape of the industry, it can be challenging to stay ahead of the competition. In this post, we'll explore effective strategies for maximizing patent protection and exclusivity, ensuring your product remains a leader in the market.
Pharmaceutical Technology
JANUARY 31, 2025
Roche achieved a sales growth of 7% (3% in CHF) in 2024, citing strong demand for pharmaceutical products.
Bio Pharma Dive
JANUARY 29, 2025
The approval adds a new indication for GLP-1 drugs and gives Novo an advantage over Lilly’s rival diabetes drug Mounjaro, which hasn’t yet proven it can improve outcomes in kidney disease.
Velocity Clinical Research
JANUARY 30, 2025
Velocity Clinical Research, the leading multi-specialty clinical research organization, has partnered with Verified Clinical Trials (VCT) to set a new benchmark for patient safety and data quality in clinical trials through a new technological implementation at Velocitys 80+ global sites. The collaboration addresses a critical industry challenge: the double enrollment of participants in multiple studies simultaneously across all clinical sites.
ACRP blog
JANUARY 28, 2025
Collection of sensitive personal data is a cornerstone of clinical research involving drugs and medical devices. However, if the personal data relates to European Union (EU) or United Kingdom (UK) residents, this raises particular legal and compliance issues due to the General Data Protection Regulation (GDPR). Securing, anonymizing, and transferring personal data is complex and challenging in these regions, especially when there is a need to share personal data with vendors and research partner
Pharmaceutical Technology
JANUARY 29, 2025
A proposed ban on PFAS chemicals is being challenged over concerns about potential supply chain disruption in the pharmaceutical industry.
Bio Pharma Dive
JANUARY 27, 2025
Taking control of O2 — ushering in the future of cell therapy research.
FDA Law Blog
JANUARY 29, 2025
By John W.M. Claud & JP Ellison The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National Institutes of Health, and the Centers for Disease Control and Prevention, Kennedys portfolio will be vast.
XTalks
JANUARY 30, 2025
In 2020, the US Food and Drug Administration (FDA) issued a Guidance for Industry recommending that sponsors include plans for developing age-appropriate formulations of drug products in instances where adult formulations may not be suitable for paediatric patients. In many cases, this guidance translates to a seemingly simple solution: for children, liquid formulations are often the preferred approach.
Pharmaceutical Technology
JANUARY 27, 2025
With continued investment and growing buzz from the industry, the AI hype is expected to extend through 2025 and beyond.
Bio Pharma Dive
JANUARY 30, 2025
The testing company ended last year with $79 million and told investors it will need to raise money to fund its operations and financial commitments.
Intouch Solutions
JANUARY 30, 2025
In a recently published article from Med Ad News , co-authors Iyiola Obayomi, SVP, Managing Director, Data & Analytics, at EVERSANA INTOUCH, and Pierantonio Russo, MD, FCPP, FAAP, STS, Chief Medical Officer at EVERSANA, discuss the power of data and analytics and machine learning (ML) to optimize HCP targeting and prescription volume. In an era where AI and ML in healthcare are driving significant prescription gains by engaging healthcare professionals (HCPs) more effectively, success now de
XTalks
JANUARY 31, 2025
The FDA has approved Journavx (suzetrigine) , a first-in-class, non-opioid treatment for adults experiencing moderate-to-severe acute pain. As an oral, selective NaV1.8 pain signal inhibitor, Journavx blocks pain at the source while avoiding the addictive risks associated with opioids. Journavx will be priced at $15.50 per 50mg pill , making it a competitively priced option in the non-opioid pain management market.
Pharmaceutical Technology
JANUARY 27, 2025
Tevogen Bio has expanded its partnership with Microsoft, aiming to further their collaboration centred on AI and advance PredicTcell.
Bio Pharma Dive
JANUARY 30, 2025
The offerings reflect an increase in IPO activity that could continue, as four other biotechs recently outlined plans to go public.
Pharma Times
JANUARY 28, 2025
Patients and care partners may find once every four weeks maintenance dosing easier
XTalks
JANUARY 29, 2025
In this episode, Ayesha spoke with Sarah Averill Lott, MPH, CPH, Research Lead at Digital Medicine Society (DiMe) and Diane Stephenson, PhD, Executive Director at the Critical Path for Parkinson (CPP) at the Critical Path Institute. DiMe is a global non-profit and a professional home for digital medicine that aims to drive the broad adoption of digital approaches to advance medicine and public health.
Pharmaceutical Technology
JANUARY 28, 2025
AB2 Bio has made an option and licensing agreement with Nippon Shinyaku, granting the latter the option to commercialise Tadekinig alfa.
Bio Pharma Dive
JANUARY 30, 2025
Robert F. Kennedy Jr., nominated to be health secretary, seemed unfamiliar with the particulars of the massive insurance program he'd oversee in exchanges with senators Thursday.
My Local Study
JANUARY 29, 2025
In the fast-paced world of clinical research, time is of the essence. Every delay in patient recruitment pushes back timelines and increases costs. Our team understands this challenge and offers a solution: a dedicated, regularly maintained database of highly motivated research volunteers ready to be matched to your study. This isn’t just a list of.
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