AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 23, 2022
The mental fog that can come with pregnancy – commonly referred to as ‘baby brain’ – isn’t merely the result of discomfort, stress, and sleepless nights: A mother’s brain really does seem to change to accommodate the new arrival. A new study by researchers from the Netherlands has uncovered strong evidence of a relationship between […].
Pharmaceutical Technology
NOVEMBER 23, 2022
The European Commission (EC) has granted approval for AbbVie ’s Skyrizi (risankizumab, 600mg intravenous [IV] induction and 360 mg subcutaneous [SC] maintenance therapy) to treat moderately to severely active Crohn’s disease in adult patients. Skyrizi is indicated for usage in such patients with insufficient response, lost response or were not tolerant to standard or biologic therapy.
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AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 23, 2022
The Indian Pharmacopoeia Commission (IPC) has rejected Central Drugs Standard Control Organisation (CDSCO)’s request for extension of timelines to implement Indian Pharmacopoeia (IP) 2022. Drugs Controller General of India (DCGI) Dr VG Somani on October 28, 2022 wrote to Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC urging him to extend the deadline for implementation of […].
Pharmaceutical Technology
NOVEMBER 23, 2022
Innovations in biotechnology are advancing the biopharmaceutical market, enabling the treatment of complex diseases with next-generation therapeutics synthesised or extracted from a biological source. Lifted by increased interest after the onset of the Covid-19 pandemic, the sector is expected to balloon to US$853 billion by 2030. One of the primary focus areas includes the continued commercialisation of cutting-edge cell and gene therapies, which involve the modification of cells from patients
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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
Bio Pharma Dive
NOVEMBER 23, 2022
The Swiss pharma and the Medicines for Malaria Venture plan to start a Phase 3 trial of a non-artemisinin combination treatment next year.
NPR Health - Shots
NOVEMBER 23, 2022
In states with abortion bans, doctors may hesitate to provide abortion care in a medical emergency. Some ethicists argue doctors should practice civil disobedience and put patients' lives first.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
NOVEMBER 23, 2022
NPR's Mary Louise Kelly talks with Kaiser Health News Correspondent Lauren Weber about her investigation into the thousands of public health workers in the U.S. who lost their jobs recently.
STAT News
NOVEMBER 23, 2022
Five months after a media investigation revealed that hospitals were feeding Meta sensitive patient information through a tracking tool on their websites, prominent systems like UPMC, Advocate Aurora, and Duke Health are still contending with the resulting legal action. The Markup and STAT News co-published an investigation in June that found one-third of Newsweek’s top 100 U.S. hospitals were using a tracker called Meta Pixel that sends Meta, formerly known as Facebook, data whenever pat
pharmaphorum
NOVEMBER 23, 2022
Each person living with a rare disease has a unique experience of their condition, but all will have faced similar challenges. They have suffered from an overwhelming diagnosis experience that has left them feeling misunderstood, isolated, and desperate for someone to help them connect symptoms and make sense of the sheer volume of information. Many will also face barriers to care, where access to specialists is limited and often geographically out of reach.
Pharma Times
NOVEMBER 23, 2022
Research showed that prescribing based solely on levels of proteins present is unlikely to be suitable
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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
NPR Health - Shots
NOVEMBER 23, 2022
Cities are once again locking down thousands of neighborhoods and sending people into quarantine, even as local Chinese authorities are tasked with easing COVID restrictions.
Pharma Times
NOVEMBER 23, 2022
Ganaplacide/lumefantrinein new study as world faces emerging resistance to malaria treatments
Fierce Pharma
NOVEMBER 23, 2022
J&J's nasal spray Spravato bests former AZ drug Seroquel XR in treatment-resistant depression trial. fkansteiner. Wed, 11/23/2022 - 09:26.
Pharma Tutor
NOVEMBER 23, 2022
Klotho : A hope for the acute kidney injury-diabetes comorbidity. admin. Thu, 11/24/2022 - 10:12. About Authors. Ajinath Kale, Anil Bhanudas Gaikwad*. Laboratory of Molecular Pharmacology, Department of Pharmacy, Birla Institute of Technology and Science Pilani, Pilani Campus, Rajasthan, India. *anil.gaikwad@pilani.bits-pilani.ac.in.
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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
NOVEMBER 23, 2022
Sporting a $3.5M price tag, CSL and uniQure's hemophilia B gene therapy crosses FDA finish line. zbecker. Wed, 11/23/2022 - 10:10.
BioSpace
NOVEMBER 23, 2022
BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
NPR Health - Shots
NOVEMBER 23, 2022
The court's decision immediately prohibited enforcement of the abortion ban statewide. The new order said seven of the nine justices had agreed to the decision.
Medical Xpress
NOVEMBER 23, 2022
Caregiving for a spouse or partner is seemingly associated with higher loneliness for those over 50 years of age, a new systemic review of published research on the issue shows.
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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.
Fierce Pharma
NOVEMBER 23, 2022
Senator aims to cut biosimilar 'red tape' with proposal to eliminate interchangeable status. kdunleavy. Wed, 11/23/2022 - 07:18.
Medical Xpress
NOVEMBER 23, 2022
For days, doctors, scientists and public health experts have been telling their Twitter followers where to find them on other platforms if Elon Musk's newly-acquired company tanks.
STAT News
NOVEMBER 23, 2022
When Ken Duckworth was a child, his family didn’t talk about mental health, especially not his father’s bipolar disorder. It was an untouchable topic, but Duckworth knew his father shouldn’t be seen as a lost cause. Instead, his father and others like him might actually have critical expertise on how to navigate the world with mental illness — expertise they gained not through books and studying but through lived experience.
Medical Xpress
NOVEMBER 23, 2022
A group of international researchers has examined parental methods to help toddlers sleep across 14 cultures and found that these methods are related to the development of a child's temperament. The researchers suggested focusing on better sleep-related parenting practices to support positive behavioral development across cultures.
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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.
STAT News
NOVEMBER 23, 2022
The U.S. has two separate health care systems: one for people who aren’t incarcerated, and one for people behind bars. Since 2006, physician and researcher Emily Wang has been working to integrate the two. “There’s really no glue, no connection between these health care systems,” Wang said. “When you have two million individuals cycling in and out of two disparate health care systems, your first thought — and I was a young physician at the time —
pharmaphorum
NOVEMBER 23, 2022
Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself. Speaking with Kornelia Lencz, senior manager at EY Consulting and a business solutions lead for the EY Smart Reviewer Platform – after a spur-of-the-moment, yet highly interesti
STAT News
NOVEMBER 23, 2022
Yale and Harvard Law Schools recently announced they would no longer participate in U.S. News & World Report’s (USNWR) flawed ranking system, followed closely by additional schools. The nation’s medical schools need to follow their lead. Why? The USNWR ranking system is in direct opposition to medical schools’ goal of educating a well-trained, diverse, and culturally competent medical workforce.
Medical Xpress
NOVEMBER 23, 2022
A new research paper titled "Krill oil protects dopaminergic neurons from age-related degeneration through temporal transcriptome rewiring and suppression of several hallmarks of aging" has been published in Aging.
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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.
STAT News
NOVEMBER 23, 2022
LOS ANGELES — In a verdict that could affect countless claims by athletes who sue sports organizations for head injuries, a Los Angeles jury on Tuesday rejected a lawsuit seeking $55 million by the widow of a former USC football player who said the NCAA failed to protect him from repeated head trauma that led to his death. Matthew Gee, a linebacker on the 1990 Rose Bowl-winning squad, endured an estimated 6,000 hits as a college athlete, lawyers for his widow said.
Medical Xpress
NOVEMBER 23, 2022
The first ever voluntary "mass testing" pilot for people without COVID symptoms was associated with an overall 25% reduction in COVID-19 related hospital admissions, including an initial 43% reduction with military assistance, finds a study published by The BMJ today.
STAT News
NOVEMBER 23, 2022
LAS VEGAS — Google has honed its message for hospital systems wary of moving their data to its cloud services: We are going to make this very easy for you. At the HLTH conference in Las Vegas this month, the company emphasized products and services that reduce the technical challenges health systems face as they look to modernize their technology infrastructure.
Medical Xpress
NOVEMBER 23, 2022
For the first time, a new study has identified enlarged perivascular spaces in the brains of migraine sufferers. Results of the study will be presented next week at the annual meeting of the Radiological Society of North America (RSNA).
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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