AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2023
As scientists continue to look for clues as to how dementia can be prevented and cured, they’ve found that the bodybuilding supplement beta-hydroxy beta-methylbutyrate (or HMB) protects against cognitive decline in mice.
Pharmaceutical Technology
AUGUST 1, 2023
BioNTech has acquired all the remaining shares of technology company InstaDeep in a deal valued at €500m ($549m) in cash.
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AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 1, 2023
India’s advanced wound care market is on the growth trajectory with faster healing & minimised scarring. This is where the positive acceptance of Negative Pressure Wound Therapy (NPWT) that uses a vacuum dressing to ensure healing in acute and chronic conditions in India is gaining popularity.
Bio Pharma Dive
AUGUST 1, 2023
The all-stock deal is a quiet end for the ambitious biotech, which was sold for its billion-dollar bank account after the FDA derailed its plans to develop low-cost cancer medicines.
Rethinking Clinical Trials
AUGUST 1, 2023
From left: NIH Collaboratory Coordinating Center co–principal investigators Lesley Curtis, Adrian Hernandez, and Kevin Weinfurt With the NIH Pragmatic Trials Collaboratory entering its second decade, we are expanding our presence on the LinkedIn social media platform to promote research that advances the design, conduct, and dissemination of pragmatic clinical trials.
Bio Pharma Dive
AUGUST 1, 2023
Revenue in the second quarter declined by 53% year over year due to lower sales of Pfizer’s coronavirus vaccine and antiviral, which have been less in demand this year.
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Bio Pharma Dive
AUGUST 1, 2023
Some on Wall Street believe the New York-based biotechnology company is now less likely to get acquired after agreeing to sell partial rights to its only marketed product.
Pharmaceutical Technology
AUGUST 1, 2023
The China National Medical Products Administration (NMPA) has accepted Astellas Pharma’s biologics licence application for zolbetuximab.
Bio Pharma Dive
AUGUST 1, 2023
The pharma’s drug Jemperli was cleared for patients with newly diagnosed endometrial tumors, but could soon face competition from Merck’s Keytruda.
Pharmaceutical Technology
AUGUST 1, 2023
The European Commission has approved Marinus Pharmaceuticals’ ZTALMY (ganaxolone) as an adjunctive treatment for epileptic seizures
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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
Rethinking Clinical Trials
AUGUST 1, 2023
Designing With Implementation in Mind Description NIH Collaboratory researchers Leah Tuzzio and Dr. Vince Mor discuss what it means to design a pragmatic trial with implementation in mind, and they share examples from 2 of the Collaboratory’s Demonstration Projects—ABATE Infection and PROVEN. Biography Leah Tuzzio, MPH Kaiser Permanente Washington Health Research Institute Vince Mor, PhD Florence Pirce Grant University Professor of Health Services, Policy and Practice, Professor of Health Servic
Pharmaceutical Technology
AUGUST 1, 2023
During the process of qualifying Cyltezo, Boehringer Ingelheim took the uncommon step of showing its interchangeability with Humira.
Drug Discovery World
AUGUST 1, 2023
Researchers from the University of Liverpool, UK, have created a biomedical compound that has the potential to stop the spread of breast cancer. Scientists from the Chemistry and Biochemistry Departments at the University of Liverpool and Nanjing Medical School in China have discovered a possible way to block proteins that cause metastasis. The major problem hindering the successful treatment of commonly occurring cancers is not the primary tumour which can usually be removed by surgery, but its
Pharmaceutical Technology
AUGUST 1, 2023
Generative AI proponents insist that with enough research and extensive testing, the technology can be used to help organizations.
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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
Outsourcing Pharma
AUGUST 1, 2023
PureTech Health plc has been awarded $11.4 million (Â8.9 million) from the US Department of Defense (DoD) to advance its therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders.
Pharmaceutical Technology
AUGUST 1, 2023
Pharma companies were awarded more grants by patents authorities in China, delivering almost five times the grants in the US.
Outsourcing Pharma
AUGUST 1, 2023
The National Health Service (NHS) research ethics committee has approved a non-cancer chronic pain clinical trial being rolled out by private health clinic LVL Health.
Pharmaceutical Technology
AUGUST 1, 2023
The announcement follows the recent initiation of a Phase I/IIa solid tumour study, which will recruit up to 117 subjects.
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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.
Outsourcing Pharma
AUGUST 1, 2023
The National Health Service (NHS) research ethics committee has approved a non-cancer chronic pain clinical trial being rolled out by private health clinic LVL Health.
Pharmaceutical Technology
AUGUST 1, 2023
Renaissance Pharma has signed an agreement to in-license St Jude Children’s Research Hospital’s Hu14.18K322A (Hu14.18).
Fierce Pharma
AUGUST 1, 2023
As COVID-19 revenues ebb and flow—but mostly ebb—Pfizer is eyeing the cost-cutting shears. | Paxlovid generated just $143 million in worldwide sales for the second quarter, while mRNA vaccine Comirnaty brought home $1.4 billion. Against that backdrop, Pfizer reported total second quarter revenues of $12.7 billion, down a whopping 53% operationally from the same period last year.
Pharmaceutical Technology
AUGUST 1, 2023
Emergent BioSolutions has won a $704m contract to develop Ebanga (ansuvimab-zykl), an FDA-approved treatment for Ebola.
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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.
Fierce Pharma
AUGUST 1, 2023
Bristol Myers Squibb and AstraZeneca have quickly resolved patent infringement lawsuits around their blockbuster cancer immunotherapies. | Bristol Myers Squibb and AstraZeneca have quickly resolved patent infringement lawsuits around their blockbuster PD-1/L1 and CTLA-4 cancer immunotherapies.
Pharmaceutical Technology
AUGUST 1, 2023
PureTech Health is developing an orally administered prodrug of neurosteroid allopregnanolone to help treat FXTAS.
Pharma Times
AUGUST 1, 2023
The approval involves the roll-out of a non-cancer chronic pain study for up to 5,000 patients - News - PharmaTimes
Pharmaceutical Technology
AUGUST 1, 2023
Vepdegestrant was awarded the Innovation Passport designation for treating advanced or metastatic breast cancer.
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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.
BioPharma Reporter
AUGUST 1, 2023
Renaissance Pharma, a company focused on the development of life changing therapies in pediatric rare disease, has entered into an exclusive license agreement with St. Jude Childrenâs Research Hospital for Hu14.18, a humanised antibody in development by the hospital for the treatment of newly diagnosed high-risk neuroblastoma.
Pharmaceutical Technology
AUGUST 1, 2023
The prevalence of nonalcoholic steatohepatitis (NASH) with no FDA-approved therapies, continues to increase.
pharmaphorum
AUGUST 1, 2023
In this episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with André Deschamps, formerly president of Europa Uomo, the voice of men with prostate cancer in Europe. Deschamps is now involved in the Let’s Talk Prostate Cancer (LTPC) Expert Group, as well as the Belgian society, Wij Ook (part of Europa Uomo).
Pharmaceutical Technology
AUGUST 1, 2023
Briumvi has been approved in the US and Europe for adults with relapsing multiple sclerosis.
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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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