AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 12, 2023
Researchers have developed a blood test to determine a person’s risk of developing anxiety, while also providing insight into its current severity and best course of treatment.
NPR Health - Shots
MARCH 12, 2023
Law enforcement organizations are promoting a new film about children being exploited into sharing sexual images and videos. But many of the film's key claims lack context.
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AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 12, 2023
The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinical trials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinical trial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.
NPR Health - Shots
MARCH 12, 2023
An unregulated landfill that accepts vegetative waste has burned underground for months. Neighbors were inundated with smoke and left wondering why the site wasn't regulated in the first place.
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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
STAT News
MARCH 12, 2023
Researchers have found long-term evidence that actively monitoring localized prostate cancer is a safe alternative to immediate surgery or radiation. The results, released Saturday, are encouraging for men who want to avoid treatment-related sexual and incontinence problems, said Dr. Stacy Loeb, a prostate cancer specialist at NYU Langone Health who was not involved in the research.
Medical Xpress
MARCH 12, 2023
The results of the clinical trial of a new wrist device designed to help control the symptoms of Tourette syndrome have shown it significantly reduces the severity and frequency of tics.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
FDA Law Blog
MARCH 12, 2023
The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. When the public health emergency ends on May 11, 2023 , so do these exemptions.
Medical Xpress
MARCH 12, 2023
Surgeons in Germany have shown a small technical change to keyhole surgery for prostate cancer can more than halve one of the most common post-operative complications—where lymphatic fluid collects in the pelvis.
BioSpace
MARCH 12, 2023
CRISPR/ViaCyte and Genprex Vie for First Diabetes Gene Therapy 3/13/2023
Medical Xpress
MARCH 12, 2023
Researchers have found long-term evidence that actively monitoring localized prostate cancer is a safe alternative to immediate surgery or radiation.
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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
JAMA Internal Medicine
MARCH 12, 2023
This cohort study examines the association of estimated life expectancy with colonoscopy findings and recommendations for surveillance colonoscopy among adults older than 65 years in New Hampshire.
Medical Xpress
MARCH 12, 2023
A scientific definition to determine whether a man's erection can be deemed a "grower " or a "shower" has been produced by researchers.
BioSpace
MARCH 12, 2023
Report Shows Expected Uptick in Layoffs and Collaboration across BioPharma 3/13/2023
Medical Xpress
MARCH 12, 2023
Vasectomies are much less likely to cause complications than expected, according to a new UK study reviewing the outcomes from over 90,000 vasectomies performed over 15 years.
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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.
BioSpace
MARCH 12, 2023
FDA Action Alert: Apellis, Pfizer, Biogen/Ionis 3/13/2023
NPR Health - Shots
MARCH 12, 2023
NPR's Michel Martin speaks with Joseph Hupy, a professor at Purdue University, about soil toxicity in Ukraine farmlands as a result of the war.
BioSpace
MARCH 12, 2023
Pfizer Wins Seagen Sweepstakes with $43B Bid 3/13/2023
JAMA Internal Medicine
MARCH 12, 2023
This JAMA Internal Medicine Patient Page describes benefits and harms of cancer screening and how to decide when it may be time to stop routine screening.
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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.
Drug Patent Watch
MARCH 12, 2023
Annual Drug Patent Expirations for KOSELUGO Koselugo is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent expiration for Astrazeneca drug KOSELUGO appeared first on DrugPatentWatch - Make Better Decisions.
Cloudbyz
MARCH 12, 2023
Clinical site qualification visits are an essential step in ensuring that clinical trial sites are qualified to conduct a study. These visits allow sponsors and contract research organizations (CROs) to assess the suitability of potential sites and verify that they meet the study requirements. Here are some best practices for conducting clinical site qualification visits: Prepare in advance Preparation is critical to the success of a site qualification visit.
Drug Patent Watch
MARCH 12, 2023
Annual Drug Patent Expirations for MEKTOVI Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are ten… The post New patent expiration for Array Biopharma drug MEKTOVI appeared first on DrugPatentWatch - Make Better Decisions.
Cloudbyz
MARCH 12, 2023
Artificial intelligence (AI) has the potential to revolutionize clinical data management (CDM) by automating many time-consuming tasks and improving the accuracy and efficiency of data analysis. In this article, we will discuss how AI can help with various aspects of CDM, including data cleaning, data validation, data analysis, and machine learning.
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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.
BioSpace
MARCH 12, 2023
Sanofi Bolsters Diabetes Position with $2.
NPR Health - Shots
MARCH 12, 2023
NPR's Ayesha Rascoe talks to Dr. Anne Lyerly, a professor and OB-GYN, about how hospital ethics boards are being invoked when a patient requires a medical exception to an abortion ban.
Drug Patent Watch
MARCH 12, 2023
DIFFERIN (adapalene) Galderma labs lp Patent: 8,703,820 Expiration: Mar 12, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com… The post Drug Patent Expirations for the Week of March 12, 2023 appeared first on DrugPatentWatch - Make Better Decisions.
NPR Health - Shots
MARCH 12, 2023
Students in a Canadian elementary school teamed with NASA to see if a life-saving drug would work in space: EpiPens.
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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.
BioSpace
MARCH 12, 2023
SVB's Fall Leaves Biotechs in Limbo 3/13/2023
Drug Patent Watch
MARCH 12, 2023
This chart shows the companies which have received the most pediatric exclusivities in the past five years. Pediatric exclusivity is granted to drug companies for conducting pediatric studies on their… The post Pharmaceutical companies with the most ‘Pediatric Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
NPR Health - Shots
MARCH 12, 2023
NPR's Michel Martin speaks with Kaiser Health News correspondent Julie Rovner about the politics of Medicare ahead of debt ceiling talks in Washington.
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