AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2023
There’s new hope for people who have lost their ability to speak. In two separate cases, scientists have successfully used brain implants and machine learning to give patients back their voice after theirs was taken; one by a stroke, the other a result of amyotrophic lateral sclerosis (ALS).
Pharmaceutical Technology
AUGUST 27, 2023
Selinexor is under clinical development by Karyopharm Therapeutics and currently in Phase II for Chronic Idiopathic Myelofibrosis (Primary Myelofibrosis).
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BioSpace
AUGUST 27, 2023
The British drugmaker filed a lawsuit on Friday in the U.S. District Court for the District of Delaware claiming the Inflation Reduction Act conflicts with the goals of the Orphan Drug Act.
Pharmaceutical Technology
AUGUST 27, 2023
Patidistrogene bexoparvovec is a gene therapy commercialized by Sarepta Therapeutics, with a leading Phase II program in Limb-Girdle Muscular Dystrophy.
BioSpace
AUGUST 27, 2023
The Swiss pharma is returning the anti-TGFβ antibody NIS793 to Xoma Corporation, from which it bought the asset in 2015 for $37 million upfront.
Pharmaceutical Technology
AUGUST 27, 2023
Selinexor is under clinical development by Karyopharm Therapeutics and currently in Phase II for Chronic Idiopathic Myelofibrosis (Primary Myelofibrosis).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 27, 2023
Following public outcry and a government investigation, Allina Health has reneged on their policy barring debtors from out-patient care.
BioSpace
AUGUST 27, 2023
Following a countersuit by Amgen and Horizon Therapeutics, the Federal Trade Commission has temporarily suspended its challenge to the multi-billion dollar merger between the two companies.
Pharmaceutical Technology
AUGUST 27, 2023
BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Cardiovascular Disease.
BioSpace
AUGUST 27, 2023
As the FDA’s recent rejection of Biogen and Sage’s zuranolone for major depressive disorder highlights, biopharma companies will need to tackle emerging challenges to bring more of these drugs to patients.
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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
Pharmaceutical Technology
AUGUST 27, 2023
BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Cardiovascular Disease.
BioSpace
AUGUST 27, 2023
The late-stage results for acoramidis, BridgeBio’s transthyretin amyloid cardiomyopathy candidate, indicate significant survival, functional and biomarker improvements over placebo.
Pharmaceutical Technology
AUGUST 27, 2023
Safinamide mesylate is under clinical development by Zambon Co and currently in Phase II for Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration).
JAMA Internal Medicine
AUGUST 27, 2023
In recent years, blood tests that look for circulating tumor DNA and biomarkers (termed liquid biopsies) have been developed. As Carr and Welch describe in this issue of JAMA Internal Medicine, these tests are being explored for diagnosis of suspected cancer, cancer surveillance after treatment, response to therapy, and chemotherapeutic selection. Most importantly, these blood tests are also being explored as multicancer early detection (MCED) tests for cancer screening in asymptomatic persons.
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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
Pharmaceutical Technology
AUGUST 27, 2023
Safinamide mesylate is under clinical development by Zambon Co and currently in Phase II for Multiple System Atrophy (MSA or Shy-Drager Syndrome or Multi-System Degeneration).
JAMA Internal Medicine
AUGUST 27, 2023
The meta-analysis examines evidence from randomized clinical trials of lifetime gained with use of screening tests for lung, breast, prostate, and colorectal cancer.
Pharmaceutical Technology
AUGUST 27, 2023
Zanidatamab is a monoclonal antibody commercialized by Jazz Pharmaceuticals, with a leading Phase III program in Adenocarcinoma Of The Gastroesophageal Junction.
JAMA Internal Medicine
AUGUST 27, 2023
This Viewpoint discusses the benefits and harms of cancer screening tests in the context of various stakeholders.
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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.
Pharmaceutical Technology
AUGUST 27, 2023
Quisovalimab is a monoclonal antibody commercialized by Avalo Therapeutics, with a leading Phase II program in Crohn's Disease (Regional Enteritis).
FDA Law Blog
AUGUST 27, 2023
By Karla L. Palmer — On Friday, August 25, 2023, FDA released a much-anticipated Final Guidance titled, “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act,” addressing FDA’s implementation of certain electronic interoperability provisions of the Drug Supply Chain Security Act (DSCSA), which were due to become effective on November 27, 2023.
Pharmaceutical Technology
AUGUST 27, 2023
Lutetium (lu177) lilotomab satetraxetan is under clinical development by Thor Medical and currently in Phase II for B-Cell Chronic Lymphocytic Leukemia.
BioSpace
AUGUST 27, 2023
In the next two weeks, the FDA will hand out regulatory verdicts to BMS, Outlook Therapeutics and BioLineRx.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Pharmaceutical Technology
AUGUST 27, 2023
Lutetium (lu177) lilotomab satetraxetan is under clinical development by Thor Medical and currently in Phase II for B-Cell Chronic Lymphocytic Leukemia.
JAMA Internal Medicine
AUGUST 27, 2023
This survey study examines career choices of internal medicine residents from 2019 to 2021 and compares them with findings from a decade earlier.
Pharmaceutical Technology
AUGUST 27, 2023
Linavonkibart is a monoclonal antibody commercialized by Scholar Rock Holding, with a leading Phase I program in Non-Small Cell Lung Cancer.
JAMA Internal Medicine
AUGUST 27, 2023
This Special Communication examines the feasibility of testing all-cause mortality for multicancer screening.
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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.
Pharmaceutical Technology
AUGUST 27, 2023
BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Duodenal Ulcer.
Drug Patent Watch
AUGUST 27, 2023
This chart shows the pharmaceutical companies with the most spray dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most spray dosed drugs… The post Which pharmaceutical companies have the most spray dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 27, 2023
BR-6002 is under clinical development by Boryung Pharmaceutical and currently in Phase I for Gastric Ulcers.
Eye on FDA
AUGUST 27, 2023
Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up – at least in terms of the volume of activity. First let’s look at the approval of new molecular entities, and then at the number of Advisory Committee meetings being held, and compare them to the first half of 2022.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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