April, 2023

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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.

Medicine 128
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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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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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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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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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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.

Doctors 145
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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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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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Judges' dueling decisions put access to a key abortion drug in jeopardy nationwide

NPR Health - Shots

A federal judge in Texas stayed the FDA's approval of the drug mifepristone, while a federal judge in Washington state blocked any FDA change in access. (Image credit: Allen G.

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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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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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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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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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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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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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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.

Scientist 145
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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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Meissner to build new $250m manufacturing facility in Athens, Georgia

BioPharma Reporter

Meissner Corporation â a company which manufactures advanced microfiltration and therapeutic manufacturing systems for pharmaceutical drugs, therapeutics, biologics, and cell and gene therapies - will invest nearly $250m in a new manufacturing facility in Athens-Clarke County in the US.

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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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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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The NIH has poured $1 billion into long Covid research — with little to show for it

STAT News

WASHINGTON — The federal government has burned through more than $1 billion to study long Covid , an effort to help the millions of Americans who experience brain fog, fatigue, and other symptoms after recovering from a coronavirus infection. There’s basically nothing to show for it.

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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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New study confirms link between 'forever chemicals' in drinking water and weight gain

Medical Xpress

A University of Rhode Island researcher has led a study that confirms a direct link between certain chemicals in drinking water and human obesity—specifically that increased PFAS content in blood promotes weight gain and makes it harder to keep a lower body weight after weight loss.

Research 145
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A Good Friday funeral in Texas. Baby Halo's parents had few choices in post-Roe Texas

NPR Health - Shots

When she gave birth to her baby with a fatal condition two months early, Samantha Casiano scrambled to raise funds for the funeral. Anti-abortion advocates say Texas laws are "working as designed.

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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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After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits

Fierce Pharma

After Johnson & Johnson loses again in bankruptcy case, it's game on for talc lawsuits kdunleavy Mon, 04/03/2023 - 06:44

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Novo boosts sales outlook on strong demand for obesity drug

Bio Pharma Dive

The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs.

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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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Enanta secures FDA fast track designation for EDP-323 to treat RSV

Pharmaceutical Technology

Enanta Pharmaceuticals has secured the US Food and Drug Administration’s (FDA) fast track designation for EDP-323 to treat respiratory syncytial virus (RSV). In vitro data of EDP-323 showed a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B. Consistent potency was also observed across a range of RSV clinical isolates in several cell types.

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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

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Broccoli consumption protects gut lining, reduces disease in mice, study shows

Medical Xpress

Broccoli is known to be beneficial to our health. For example, research has shown that increased consumption of the cruciferous vegetable decreases incidences of cancer and type 2 diabetes. In a recent study, researchers at Penn State found that broccoli contains certain molecules that bind to a receptor within mice and help to protect the lining of the small intestine, thereby inhibiting the development of disease.

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Biden administration says fentanyl-xylazine cocktail is a deadly national threat

NPR Health - Shots

The White House says drug deaths linked to a mix of synthetic drugs including fentanyl and xylazine — also known as tranq — are a major public health threat. The drug cocktail is spreading fast.

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Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval

Fierce Pharma

Eli Lilly's weight-loss drug passes 2nd trial with flying colors, setting up likely approval aliu Wed, 04/26/2023 - 22:30

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Seagen, Astellas win expanded FDA approval for bladder cancer drug

Bio Pharma Dive

The first-line approval of Padcev together with Keytruda is viewed as important to expanding the drug’s market, and comes weeks after Pfizer agreed to buy Seagen for $43 billion.

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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.