April, 2023

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Twist Bioscience and Astellas team up for antibody discovery

Pharmaceutical Technology

Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. This is the third collaboration between the two companies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.

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Merck to buy inflammatory disease drugmaker Prometheus for $10.8B

Bio Pharma Dive

The pharma has struck the sector’s second-largest buyout this year, announcing a deal for the developer of an inflammatory bowel disease treatment that’s shown promise in testing.

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Led by students, a nascent climate movement is taking hold in medical education

STAT News

When Cecilia Sorensen was an emergency medicine resident practicing at Denver Health in Colorado a few years ago, summer was known as “trauma season.” Gunshot and motor vehicle accident victims, people with heart attacks and COPD would stream into the ER. Later, on a fellowship, she witnessed the health impacts of drought in Syria. The common driver, she realized, was climate change and its impact, both locally and globally.

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There’s Something Different in The Brains of Teens With Sleep Apnea

AuroBlog - Aurous Healthcare Clinical Trials blog

Interruptions to breathing during sleep may cause parts of the adolescent brain critical to learning and memory to become thin or inflamed, according to a record-sized study carried out on US teenagers.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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April 24, 2023: Webinar Will Highlight Meaningful Engagement of Patients and Communities in NIH HEAL Initiative Studies

Rethinking Clinical Trials

An upcoming webinar in the NIH HEAL Initiative’s HEAL Headliners series will highlight the experiences of 2 projects in meaningfully engaging patients and community partners throughout the research process to ensure that the findings have the greatest public health impact. The webinar will be held on Friday, May 5, 2023, at 2:00 pm eastern. Rosemarie Martin of Brown University and Linda Hurley of CODAC Behavioral Heathcare will report on a study of a systems-change approach for increasing

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In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

Fierce Pharma

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35

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FDA approves new ALS medicine in precedent-setting decision

Bio Pharma Dive

Biogen’s drug failed the key study meant to show it can slow the nerve-destroying disease, but the drug’s effect on a protein of interest led the FDA to conditionally clear it for market.

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Tired of ‘dead end’ approach, herpes patients mobilize to demand government action

STAT News

A medical student spoke emotionally about grappling with a diagnosis his classes told him little about. A young queer man took one test, got a different result on the next, and is now saving up the money needed for the most advanced diagnostics, which insurers rarely cover. A young woman tested positive, got little guidance from her doctor and found information on government sites that she interpreted as pushing abstinence.

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US Scientist to Live Underwater For 100 Days in Record-Breaking Experiment

AuroBlog - Aurous Healthcare Clinical Trials blog

As nightmares go, being trapped in a small box deep underwater is probably high on many people’s lists. But one US professor is doing this on purpose.

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Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)

Rethinking Clinical Trials

                                           Speaker Kanecia Zimmerman, MD, PhD, MPH Associate Professor of Pediatrics Duke Clinical Research Institute Duke University School of Medicine Slides Keywords COVID-19, RECOVER, Clinical Trials Key Points Long COVID is a set of multiple conditions with diverse clinical manifestations that can affect every major organ/tissue system, reflecting varied potential underlying and co-existing causes.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations

Fierce Pharma

Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04

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Breathing easy: How digital inhalers are changing asthma treatment

Pharmaceutical Technology

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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5 FDA decisions to watch in the second quarter

Bio Pharma Dive

By the end of June, the agency could clear a gene therapy for Duchenne muscular dystrophy and two vaccines for RSV, as well as issue a precedent-setting decision on a closely watched ALS drug.

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New injectable cell therapy could resolve osteoarthritis

Medical Xpress

Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage.

Scientist 145
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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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Groundbreaking mRNA Therapy Appears To Prevent and Treat Peanut Allergies in Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

More treatments – and faster-acting treatments – for peanut allergies are urgently needed, and a new study outlines a promising drug technology based around a tiny nanoparticle just a few billionths of a meter in size. In tests on mice, the nanoparticle reversed peanut allergies and prevented them from developing in the first place.

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As pandemic emergencies end, some patients with long COVID feel 'swept under the rug'

NPR Health - Shots

Millions of Americans suffer from long COVID, which can have debilitating physical effects, including fatigue and difficulty breathing. Yet many patients feel abandoned, as federal aid winds down.

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Q&A: Chronicling the failures of the U.S. response to Covid

STAT News

A new book on the U.S. response to the Covid-19 pandemic paints a picture of a country ill-prepared to cope with a dangerous biological foe, riven by partisan politics, and led by people who saw little political gain in taking ownership of managing the crisis. It also describes a country that remains ill-equipped to battle the next pandemic or major disease threat, though it lays out changes that could strengthen the country’s position.

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Ghana becomes first country to approve Oxford’s malaria vaccine

Pharmaceutical Technology

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

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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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Moderna, Merck data support claim of cancer vaccine’s promise

Bio Pharma Dive

Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.

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Brain images just got 64 million times sharper

Medical Xpress

Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization.

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PCIM&H soon to develop pharmacopoeia standards for Ayurveda, Siddha, Unani & Homoeopathy drugs

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacopoeia Commission of Indian Medicine and Homoeopathy (PCIM&H) may soon undertake development of pharmacopoeia standards for the Ayurveda, Siddha, Unani and Homoeopathy drugs under the ‘One Herb One Standard’ (OHOS) among other initiatives during the financial year 2023-24.

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COVID during pregnancy may alter brain development in boys

NPR Health - Shots

Boys born to mothers who got COVID-19 while pregnant seem to have a higher risk of subtle developmental delays, including those associated with autism spectrum disorder.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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In counties with more Black doctors, Black people live longer, ‘astonishing’ study finds

STAT News

Black people in counties with more Black primary care physicians live longer, according to a new national analysis that provides the strongest evidence yet that increasing the diversity of the medical workforce may be key to ending deeply entrenched racial health disparities. The study , published Friday in JAMA Network Open, is the first to link a higher prevalence of Black doctors to longer life expectancy and lower mortality in Black populations.

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Dyadic expands Covid-19 licence with Rubic to bolster vaccine production in Africa

Pharmaceutical Technology

Dyadic International has announced expansion of a licence agreement for its C1-cell protein expression platform with South African consortium Rubic One Health. The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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Gene therapy startup Vedere to close two years after launch

Bio Pharma Dive

The startup, a successor to an eye gene therapy biotech that Novartis bought in 2020, will wind down after preclinical experiments didn’t meet the bar set by its leaders.

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No magic number for time it takes to form habits, finds new study

Medical Xpress

Putting on your workout clothes and getting to the gym can feel like a slog at first. Eventually, you might get in the habit of going to the gym and readily pop over to your Zumba class or for a run on the treadmill. A new study from social scientists at Caltech now shows how long it takes to form the gym habit: an average of about six months.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Delhi HC refuses interim injunction to Boehringer Ingelheim, permits generic manufacturers to produce linagliptin

AuroBlog - Aurous Healthcare Clinical Trials blog

A Single Bench of the Delhi High Court has refused to grant interim injunction in favour of German pharma major Boehringer Ingelheim against the Indian generic manufacturers in a patent litigation on the former’s diabetes drug linagliptin, noting that prima facie the patent is vulnerable to revocation and the company has made an attempt towards […]

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You're less likely to get long COVID after a second infection than a first

NPR Health - Shots

The chances of developing lingering symptoms after COVID appears to fall sharply from the first to the second time someone gets sick, new research finds. The risk is still significant.

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Demand for home health aides is soaring. So why are they still so undervalued?

STAT News

On most days around 2pm, home health aide Duane Crichlow can be found in an apartment in Sunset Park, Brooklyn, playing catch with his client — a man in his 30s with a developmental disability who is quick to give Crichlow hugs and kisses. If it’s nice outside, Crichlow will walk his client, who is nonverbal and in a wheelchair half the time, down three flights of stairs, hauling the wheelchair back and forth separately.

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Latest WHO Covid-19 vaccine guidance may decrease future demand

Pharmaceutical Technology

The World Health Organisation (WHO) has revised its recommendations regarding the use of Covid-19 vaccines following a meeting of the agency’s Strategic Advisory Group of Experts on Immunisation (SAGE). The latest guidance applies to the current phase of the pandemic and reflects the impact of the Omicron variant, which has led to high levels of immunity in all age groups through both vaccination efforts and infections across the globe.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g