Sun.Mar 19, 2023

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HIV testing and diagnosis severely disrupted in three years of Covid-19 pandemic at AIIMS

AuroBlog - Aurous Healthcare Clinical Trials blog

HIV testing and diagnosis was severely disrupted in the three years of Covid-19 pandemic at All India Institute of Medical Sciences (AIIMS), according to an AIIMS study which covered the documents or records on HIV testing and diagnosis from January 1, 2016 to December 31, 2022.

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California enters a contract to make its own affordable insulin

NPR Health - Shots

Under the $50 million deal, the state is partnering with drugmaker Civica to start making the new generic insulin later this year, Gov. Gavin Newsom said.

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Is a common industrial chemical fueling the spread of Parkinson's disease?

Medical Xpress

A cancer-causing chemical that is widely used to degrease aviation components and heavy machinery could also be linked to Parkinson's disease, according to a new research paper that recommends increased scrutiny of areas long contaminated by the compound.

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A new Arkansas law allows an anti-abortion monument at the state Capitol

NPR Health - Shots

Arkansas Gov. Sarah Huckabee Sanders has signed a law to allow a monument near the state Capitol marking the number of abortions performed in Arkansas before Roe v. Wade was overturned. (Image credit: Phelan M.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Multi-drug resistant organisms can be transmitted between healthy dogs and cats and their hospitalised owners

Medical Xpress

Healthy dogs and cats could be passing on multidrug-resistant organisms (MDROs; bacteria that resist treatment with more than one antibiotic) to their hospitalized owners, and likewise humans could be transmitting these dangerous microbes to their pets, according to new research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (15-18 April).

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Opioids are devastating Cherokee families. The tribe has a $100 million plan to heal

NPR Health - Shots

The fentanyl crisis is hitting young people hard, and the highest death rates are in Native American communities. The Cherokee Nation is working to help young families recover.

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Six-Year Cognitive Trajectory in Older Adults Following Major Surgery and Delirium

JAMA Internal Medicine

This cohort study examines the patterns and pace of cognitive decline up to 72 months in a cohort of older adults following delirium.

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FDA Releases Briefing Docs for Upcoming Biogen/Ionis Tofersen Adcomm

BioSpace

FDA Releases Briefing Docs for Upcoming Biogen/Ionis Tofersen Adcomm 3/20/2023

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New immunotherapy strategies in targeting complexity in the tumor microenvironment

Medical Xpress

A symposium aiming to provide a better understanding of the tumor microenvironment, immune tolerogenic niches at cancer initiation, and novel immunotherapeutic strategies in head and neck cancer patients was featured at the 52nd Annual Meeting & Exhibition of the AADOCR, held in conjunction with the 47th Annual Meeting of the CADR. The AADOCR/CADR Annual Meeting & Exhibition took place at the Oregon Convention Center in Portland on March 15-18, 2023.

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Raises for Moderna, Pfizer CEOs Highlight Continuing Trend

BioSpace

Raises for Moderna, Pfizer CEOs Highlight Continuing Trend 3/20/2023

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Giant T-wave Inversion and Loss of Consciousness

JAMA Internal Medicine

This case report describes a patient in their 60s with long-term uncontrolled hypertension and possible hip fracture followed by loss of consciousness.

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Novartis, Biogen Scrap Gene Regulation Partnerships with Sangamo

BioSpace

Novartis, Biogen Scrap Gene Regulation Partnerships with Sangamo 3/20/2023

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The relationship between climate change and rising disease

NPR Health - Shots

NPR's Pien Huang talks to Dr. Benjamin Beard, deputy director of the CDC's division of vector borne diseases, about how climate change could be contributing to the spread of diseases.

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Takeda’s $4B Plaque Psoriasis Candidate Clears Mid-Stage Study

BioSpace

Takeda’s $4B Plaque Psoriasis Candidate Clears Mid-Stage Study 3/20/2023

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Acesion's positive trial data for treatment of atrial fibrillation

Outsourcing Pharma

Positive data from a phase 2 clinical trial has proven the general mechanism of action of SK channel inhibition for treatment of atrial fibrillation (AF), an abnormal heart rhythm.

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Karuna’s KarXT Aces Third Registrational Study in Schizophrenia

BioSpace

Karuna’s KarXT Aces Third Registrational Study in Schizophrenia 3/20/2023

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Informa Connect’s Annual Life Sciences Commercial Contracts & Chargebacks Congress

Drug Channels

Informa Connect’s Annual Life Sciences Commercial Contracts & Chargebacks Congress May 16-17, 2023 The Omni Shoreham Hotel | Washington, DC Hybrid Event informaconnect.com/contracts-chargebacks Exclusive Offer for Drug Channels Readers: Register Now to SAVE 10% * using promo code 23DC10 Informa Connect’s 19th Annual Commercial Contracts & Chargebacks Congress , taking place May 16-17 in Washington, DC, offers crucial updates on policy changes and contracting best practices to increase ef

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FDA Action Alert: Biogen/Ionis, Cidara and Incyte

BioSpace

FDA Action Alert: Biogen/Ionis, Cidara and Incyte 3/20/2023

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The New Age of Decentralized Clinical Trials

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.

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Assessment of Patient Education Delivered at Time of Hospital Discharge

JAMA Internal Medicine

This quality improvement study describes whether key communication domains were addressed at the bedside on the day of hospital discharge, by whom, and for how long.

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Sponsored: Inspirational Space Sparks Scientific Innovation at the First Life Sciences Building i.

BioSpace

Sponsored: Inspirational Space Sparks Scientific Innovation at the First Life Sciences Building i.

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Which pharmaceutical drugs have the most drug patents in Argentina?

Drug Patent Watch

This chart shows the drugs with the most patents in Argentina. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Argentina? appeared first on DrugPatentWatch - Make Better Decisions.

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Decentralized Clinical Trial Management: The Future of Clinical Trials

Cloudbyz

Decentralized Clinical Trial Management is a new approach to conducting clinical trials that leverages decentralized technologies such as blockchain, smart contracts, and distributed computing to streamline the clinical trial process. The goal of decentralized clinical trial management is to provide a secure, efficient, and effective solution for conducting clinical trials that is transparent, tamper-proof, and scalable.

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Accelerating Clinical Supply Through Integrated Drug Development

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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HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval

FDA Law Blog

Hyman, Phelps & McNamara, P.C.’s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. The article arose out of work conducted by the Pathway Development Consortium , a partnership between stakeholders in the AAV gene therapy space.