Tue.Dec 27, 2022

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Looking back at 2022: The top healthcare stories

Pharmaceutical Technology

The healthcare industry saw its share of ups and downs in 2022. Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions. Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced.

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Three years on, the pandemic — and our response — have been jolting. Here’s what even the experts didn’t see coming

STAT News

People who study infectious diseases and who work in public health have long known a bad pandemic would one day come. They knew such an event would overwhelm hospitals, strain supply chains, and place stresses on society that we would be ill-equipped to meet. Countries like the United States have for decades prepared to respond to such a crisis.

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India’s Hetero receives WHO approval for Nirmacom to treat Covid-19

Pharmaceutical Technology

Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor. Hetero’s Nirmacom combi-pack will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet).

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Maternal deaths in the U.S. are staggeringly common. Personal nurses could help

NPR Health - Shots

The nation has the highest rate of maternal mortality among wealthy countries. A long-standing program, Nurse-Family Partnership, which supports new parents, works to address this deadly trend.

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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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2022 in Review: Tracking the ups and downs of pharma deals

Pharmaceutical Technology

This year, volatility resulting from the Russian war on Ukraine, residual uncertainty from the Covid-19 pandemic, and more led to fluctuating dynamics in the pharmaceutical space. However, despite external pressures, major pharma deals still came to pass, which some experts say could be a harbinger for things to come in 2023. The Covid-19 pandemic pushed most markets into free fall, leading to increased wariness for completing large mergers and acquisitions (M&As) in the pharmaceutical secto

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Psychedelic drugs may launch a new era in psychiatric treatment, brain scientists say

NPR Health - Shots

Psychedelic drugs were a hot topic at this year's Society for Neuroscience meeting. Researchers hope the drugs can help people with disorders like depression and PTSD.

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Supreme Court allows border restrictions for asylum seekers to continue for now

NPR Health - Shots

The justices agreed to decide in its February argument session whether 19 states that oppose the Title 42 policy should be allowed to intervene in defense of it in the lower courts (Image credit: Veronica G.

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Swedish study finds more obesity in three- and four-year-olds during pandemic

Medical Xpress

The incidence of overweight and obesity in children aged three and four in Sweden increased during the pandemic, especially in more deprived areas, a study of just over 25,000 children in three Swedish counties shows.

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Opinion: To effectively combat diabetes, policymakers must treat obesity like other diseases

STAT News

Obesity is often included in the litany of chronic diseases that plague six in 10 Americans — except by Medicare, which currently refuses to cover treatment for obesity until it causes significant health problems like diabetes or heart disease. The growing number of Americans with obesity is helping drive the chronic disease crisis in the U.S. and deepening existing health inequities.

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Brain area necessary for fluid intelligence identified

Medical Xpress

A team led by UCL and UCLH researchers have mapped the parts of the brain that support our ability to solve problems without prior experience—otherwise known as fluid intelligence.

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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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USA Clinical Trial Market Size and Opportunities

ProRelix Research

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

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New biomarker test can detect Alzheimer's neurodegeneration in blood

Medical Xpress

A group of neuroscientists led by a University of Pittsburgh School of Medicine researcher developed a test to detect a novel marker of Alzheimer's disease neurodegeneration in a blood sample. A study on their results was published today in Brain.

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STAT+: Get ready for ‘the electric vehicles of biopharma’: Three biotech trends to watch in 2023

STAT News

Predicting the future is famously a mug’s game. Between Covid-19, drug pricing legislation, and a dramatic turn of events in neuroscience, the last few years of biotech history have been volatile to the point of capriciousness.

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Health care is increasingly unaffordable for people with employer-sponsored health insurance—especially women: Analysis

Medical Xpress

Health care is growing less affordable for U.S. adults—particularly women—with employer-sponsored health insurance, according to an analysis by researchers at the NYU School of Global Public Health published in the Journal of the American Medical Association (JAMA).

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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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EOY wrap-up: What’s ahead in clinical trial patient recruitment?

Antidote

Though clinical trials as we know them have only existed since the 1980s , the past 40 years have been ripe with innovations in the process. From an increased focus on the patient experience to the rise of clinical trial matching software, the world of medical research continues to grow and evolve.

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New method predicts the right treatment for breast cancer patients

Medical Xpress

Researchers at Karolinska Institutet have developed a method that should be able to predict whether a patient with breast cancer will benefit from a particular treatment or not. The cell-based method has been tested on patients with promising results, according to a study published in Proceedings of the National Academy of Sciences.

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Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma

Fierce Pharma

Roche gets FDA nod for Lunsumio, offering convenient option to gene therapies in follicular lymphoma. kdunleavy. Tue, 12/27/2022 - 09:16.

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AI-powered technology sees big improvements in UK stroke treatment: analysis

Medical Xpress

Artificial intelligence technology has tripled the number of UK stroke patients recovering to a point where they can perform daily activities, according to new research released on Tuesday.

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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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New patent for HANDA drug TASCENSO ODT

Drug Patent Watch

Annual Drug Patent Expirations for TASCENSO+ODT Tascenso Odt is a drug marketed by Handa and is included in one NDA. There are three patents protecting this drug. This drug has…. The post New patent for HANDA drug TASCENSO ODT appeared first on DrugPatentWatch - Make Better Decisions.

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Holiday burnout: Why it happens and three research-proven ways to help you recover

Medical Xpress

Although Christmas only lasts a few days each year, many of us spend months planning for it. But as enjoyable as all the parties and festivities might be, many people find they feel a bit burnt-out once the holidays have come and gone. This feeling has even been termed "festive burnout" or "holiday burnout." Here's why this happens—and what you can do to recover after the holidays are over.

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FDA Approves Gene Therapy Adstiladrin for the Treatment of Bladder Cancer

XTalks

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Adstiladrin is an adenoviral vector-based gene therapy that is non-replicating, so it cannot multiply in human cells.

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Heart rate variability—what to know about this biometric most fitness trackers measure

Medical Xpress

Your heart beats around 100,000 times every day. Heart rate is a key marker of cardiovascular activity and an important vital sign. But your pulse is not as steady as a precision clock—nor would you want it to be.

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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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‘Never Miss’ Campaign for Prostate Cancer Awareness Launched by AstraZeneca and Merck

XTalks

AstraZeneca and Merck joined hands to launch a prostate cancer awareness campaign called ‘ Never Miss.’ The campaign leverages sport in addition to an informational website and social media activity to help men learn about prostate cancer and how to get tested for it. As many people may feel uncomfortable discussing prostate cancer, the website also aims to help individuals overcome this by advising people how to talk to their doctor and loved ones about prostate cancer and how to approach conve

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Risk for persistent postural perceptual dizziness increases with vestibular conditions, study finds

Medical Xpress

Patients with multiple vestibular conditions have an increased risk for persistent postural perceptual dizziness (PPPD), according to study published online Oct. 27 in Audiology Research.

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Benefits of Structured Content in Preparing Data for Regulatory Submissions

Pharmaceutical Commerce

How taking steps to incorporate data into all regulatory and labeling operations helps firms avoid retroactively planning to recapture information.

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Hundreds of US hospitals sue patients or threaten their credit, investigation finds

Medical Xpress

Despite growing evidence of the harm caused by medical debt, hundreds of U.S. hospitals maintain policies to aggressively pursue patients for unpaid bills, using tactics such as lawsuits, selling patient accounts to debt buyers, and reporting patients to credit rating agencies, a KHN investigation shows.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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New tentative approval for Teva Pharms drug eltrombopag

Drug Patent Watch

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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Time spent in nature appears to slow Parkinson's, Alzheimer's

Medical Xpress

Living in an area with easy access to parks and rivers appears to slow the progression of devastating neurological diseases, such as Alzheimer's and Parkinson's.

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New tentative approval for Amneal Pharms drug saxagliptin

Drug Patent Watch

[![saxagliptin structure]([link] Saxagliptin is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this compound. There are…. The post New tentative approval for Amneal Pharms drug saxagliptin appeared first on DrugPatentWatch - Make Better Decisions.

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Factors linked to pediatric mental health emergency revisits identified

Medical Xpress

Pediatric mental health emergency department visits are increasing, and markers of severe disease and health care access are associated with mental health revisits, according to a study published online Dec. 27 in JAMA Pediatrics.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.