Tue.Mar 07, 2023

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

Protein 360
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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

Drugs 362
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One Medical CEO rebuts Amazon data privacy concerns

Pharmaceutical Technology

The recently closed Amazon-One Medical acquisition focuses on a “longitudinal relationship” with individual members and has nothing to do with patient data, said One Medical’s CEO Amir Dan Rubin, amidst data privacy concerns surrounding the deal, at a recent panel. On 6 March, at the Wall Street Journal (WSJ) Health Forum, Rubin said the deal should not invite any data privacy concerns given its structure.

Pharmacy 195
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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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BioMarin, as expected, sees delay to FDA review of hemophilia gene therapy

Bio Pharma Dive

The agency is considering three-year follow-up data in its review of Roctavian, pushing back the potential U.S. arrival of BioMarin’s drug once again.

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Huge New Study Shows Why Exercise Should Be The First Choice in Treating Depression

AuroBlog - Aurous Healthcare Clinical Trials blog

Exercise should be the primary treatment for depression and other common mental health conditions, according to University of South Australia (UniSA) researchers. The most comprehensive review of research to date shows that mild to moderate symptoms of depression, anxiety, and psychological distress can be alleviated with physical activity. According to their investigation, exercise is 1.

Research 177

More Trending

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Perimenopause: Tackling the dearth of treatments for anxiety and depression

Pharmaceutical Technology

Due to a growing body of research, the connection between mental health and perimenopause is becoming clearer, namely its impact on mood and the onset of depression and anxiety. However, despite focused efforts in scientific research, this connection is still largely unexplored in the pharmaceutical space. Perimenopause refers to the stage of menopausal transition when an irregularity in the menstrual cycle symptoms may arise before the last menstrual bleed.

Hormones 130
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Flagship’s latest startup emerges with a plan for ‘smarter biologics’

Bio Pharma Dive

Ampersand Biomedicines claims to be developing a way to make medicines that act only at the site of disease and spare healthy tissue.

Medicine 204
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March 7, 2023: Webinar on Causal Inference in Pragmatic Trials Coming to IMPACT Collaboratory

Rethinking Clinical Trials

In the March 16 session of IMPACT Grand Rounds, the NIA IMPACT Collaboratory will host Dr. Eleanor Murray, who will present on the topic of causal inference in pragmatic trials. From the announcement : Join us for IMPACT Grand Rounds on Thursday, March 16 at 12pm ET with Dr. Murray who will be presenting on the “Causal Inference in Pragmatic Trials.

Trials 130
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Biden’s plan to extend Medicare solvency targets prescription drugs

Bio Pharma Dive

The proposal — part of a 2024 budget set to be released Thursday — would further reduce what Medicare pays for prescription drugs and raise taxes on Americans earning over $400,000.

Drugs 130
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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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Health ministry to allow drug imports through Gangavaram Port in Andhra Pradesh

AuroBlog - Aurous Healthcare Clinical Trials blog

The ministry of health and family welfare (MoHFW) will soon allow import of drugs into India through Gangavaram Port at Visakhapatnam, in Andhra Pradesh, an all-weather deep-water port owned by Adani Ports and Special Economic Zone (APSEZ).

Drugs 135
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NYC Mayor Eric Adams is telling stores to have customers remove their face masks

NPR Health - Shots

"We are putting out a clear call to all of our shops: Do not allow people to enter the store without taking off their face mask," the mayor said. A flurry of questions ensued.

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How one medical school became remarkably diverse — without considering race in admissions

STAT News

The diversity of medical school classes has barely budged in recent decades, even with the ability to consider an applicant’s race as one factor in admissions. Now, many medical school leaders fear a looming U.S. Supreme Court decision to restrict or ban race-conscious admissions policies could lead to precipitous declines, imperiling efforts to fight the nation’s stark racial and ethnic health disparities.

Research 111
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5 Texas Women Denied Abortions Sue The State, Saying Bans Put Them in Danger

NPR Health - Shots

The lawsuit filed on behalf of five patients who said their lives were put at risk and two physicians asks a state judge to clarify exceptions for medical emergencies under Texas law.

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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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Researchers create mutant mice to study bipolar disorder

Medical Xpress

Bipolar disorder (BD) is a debilitating condition characterized by alternating states of depression (known as depressive episodes) and abnormal excitement or irritability (known as manic episodes). Large-scale genome-wide association studies (GWASs) have revealed that variations in the genes present on the fatty acid desaturase (FADS) locus are linked to an increased risk of BD.

Genome 105
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What SNAP recipients can expect as benefits shrink in March

NPR Health - Shots

Participants in the federal food program might want to reevaluate their eligibility level for SNAP — and consider other assistance programs — as a pandemic-era supplement ends this month.

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AI accurately identifies normal and abnormal chest X-rays

Medical Xpress

An artificial intelligence (AI) tool can accurately identify normal and abnormal chest X-rays in a clinical setting, according to a study published in Radiology.

Radiology 105
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California will cut ties with Walgreens over the company's plan to drop abortion pills

NPR Health - Shots

California Gov. Gavin Newsom said that the state would halt business with Walgreens after the pharmacy giant agreed to stop distributing mifepristone in some red states amid legal pressure. (Image credit: Michael M.

Pharmacy 115
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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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Annual tap water scald burns in US exact high personal and financial costs

Medical Xpress

Tap water scald burns exact high personal and financial costs every year in the U.S., finds an audit of relevant national data, published online in the journal Injury Prevention.

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With CRISPR cures on horizon, sickle cell patients ask hard questions about who can access them

STAT News

LONDON — Victoria Gray had come to Nashville, Tenn., from her home in Mississippi for what was supposed to be a routine checkup. But when a pain crisis struck — an agonizing emergency of sickle cell disease in which Gray’s misshapen red blood cells caught in her blood vessels — the visit became a days-long hospital stay. It was in the midst of this attack that her doctor told her about a clinical trial for a new kind of treatment, one where CRISPR would be used to alt

DNA 98
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Researcher finds olive oil to improve brain health, memory in mild cognitive impairment individuals

Medical Xpress

Extra virgin olive oil may have positive effects on individuals with mild cognitive impairment, according to a recently completed study by Amal Kaddoumi in Auburn University's Harrison College of Pharmacy. Her findings, recently published in the journal Nutrients, suggest compounds found in olive oil impact brain health and improve the blood-brain barrier.

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How can states keep people insured after Medicaid protections lapse? Connecticut has an idea

STAT News

WASHINGTON — It’s hard to shop for health insurance. It’s harder still when there’s few options to help. Some Americans who can’t rely on a federal program or their employers’ HR department turn to brokers who are trained to help them navigate the complex web of deductibles, formularies, and subsidies. But in 2021 in Hartford, Bridgeport, and New Haven, Connecticut — as in many poorer areas in the U.S.

HR 98
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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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Hunter-gatherer childhoods may offer clues to improving education and well-being in developed countries

Medical Xpress

Published today in the Journal of Child Psychology and Psychiatry, a new study by Dr. Nikhil Chaudhary, an evolutionary anthropologist at the University of Cambridge, and Dr. Annie Swanepoel, a child psychiatrist, calls for new research into child mental health in hunter-gatherer societies. They explore the possibility that some common aspects of hunter-gatherer childhoods could help families in economically developed countries.

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STAT+: Q&A: Califf on obesity drugs, advisory panels, and how threats hurt recruitment at FDA

STAT News

BOSTON — FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. But he also said he saw it as an example of a drug company filling the void left by health systems that aren’t teaching doctors and trainees how to use new medicines.

Drugs 98
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Increased hospitalizations for heart attacks, heart failure seen in older adults living near fracking sites

Medical Xpress

A new University of Chicago study examining Medicare claims found older adults living near fracking sites in Pennsylvania were more likely to be hospitalized for cardiovascular diseases than those who lived in nearby New York state, where fracking is banned. The research was published in The Lancet Planetary Health.

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STAT+: Best Buy-Atrium deal offers glimpse of tech’s future in home health

STAT News

Best Buy isn’t the first name that comes to mind when people think of health care. But a new partnership between the electronics retailer and Atrium Health, part of the nonprofit health system Advocate Health, is a sign of how big tech and retail companies are getting in on the booming hospital-at-home market. Best Buy first dove into the health care space with its 2021 acquisition of Current Health, a remote patient monitoring platform that major hospital systems across the country rely

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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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Enhancing at-home COVID tests with glow-in-the dark materials

Medical Xpress

Researchers at the University of Houston are using glow-in-the-dark materials to enhance and improve rapid COVID-19 home tests. If you've taken an at-home COVID-19 or pregnancy test, then you've taken what is scientifically called a lateral flow assay (LFA) test, a diagnostic tool widely used because of its rapid results, low cost and ease of operation.

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STAT+: Controversial drug for premature birth is withdrawn by manufacturer after battle with FDA

STAT News

After months of anticipation, the manufacturer of a controversial drug for premature births has agreed to withdraw its treatment, capping an unusual battle with the U.S. Food and Drug Administration over its authority to have medicines removed from the market. The drug in question, called Makena, was approved more than a decade ago and quickly generated a firestorm over its cost.

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Researchers find rate of fatal opioid poisonings among children more than doubled over 13-year span

Medical Xpress

Researchers from Children's Hospital of Philadelphia (CHOP) have found that opioids were responsible for more than half of all fatal poisonings in children ages 5 and younger between 2005 and 2018, more than double the proportion of fatal poisonings caused by opioids in 2005. Additionally, over-the-counter drugs still contribute to fatal poisonings in this age group despite increased regulation.

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International Women’s Day: Female life science leaders

Drug Discovery World

For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. The life sciences sector has traditionally outperformed others when it comes to attracting women to its workforce. In its ‘Women in Business 2022’ report, Grant Thornton reported that at 39%, the healthcare industry had the highest proportion of women in senior management out of the 15 industries surveyed. 1 However, this progress seems t

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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.