Sun.Jan 22, 2023

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FDA accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.

Trials 264
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Some People’s Brains Are Wrinklier Than Others, And Now We Know Why

AuroBlog - Aurous Healthcare Clinical Trials blog

The folds of the human brain are instantly recognizable. Snaking ridges and deep furrows give the squishy tissue inside our heads structure and the appearance of a wrinkly walnut.

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Most Americans say overturning Roe was politically motivated, NPR/Ipsos poll finds

NPR Health - Shots

An NPR/Ipsos poll finds that most Americans say Supreme Court justices are guided more by their politics than the law, and that lawmakers aren't deciding abortion policy based on public sentiment.

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Shortage of teachers in govt ayurveda medical colleges hits ISM education in Telangana

AuroBlog - Aurous Healthcare Clinical Trials blog

The vacancies of teaching faculties in the two government ayurveda medical colleges in the state of Telangana still remain vacant despite pressures from association of ayurveda doctors and educational experts on the government wanting appointment of regular faculties.

Doctors 162
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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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Scientists explain emotional 'blunting' caused by common antidepressants

Medical Xpress

Scientists have worked out why common anti-depressants cause around half of users to feel emotionally "blunted." In a study published today in Neuropsychopharmacology, they show that the drugs affect reinforcement learning, an important behavioral process that allows people to learn from their environment.

Scientist 137
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50 years after Roe v. Wade, many abortion providers are changing how they do business

NPR Health - Shots

The overturning of the Roe v. Wade decision just months ahead of its 50th anniversary has prompted many abortion providers to shift how they serve patients. (Image credit: Rogelio V.

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On 50th anniversary of Roe v. Wade, Kamala Harris urges federal abortion protections

NPR Health - Shots

In a speech delivered on Sunday, the vice president advocated for Congress to take action to protect abortion rights.

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Make 2023 the year of prioritizing women’s health

STAT News

Thirty years ago this week, the bill that became the National Institutes of Health Revitalization Act of 1993 — a game changer for research on women’s health — was introduced into the U.S. Senate by Sen. Ted Kennedy (D-Mass.). This landmark act has helped significantly improve women’s health in the United States and around the world.

Research 105
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Climate change trauma has real impacts on cognition and the brain, wildfire survivors study shows

Medical Xpress

Psychological trauma from extreme weather and climate events, such as wildfires, can have long-term impacts on survivors' brains and cognitive functioning, especially how they process distractions, my team's new research shows.

Research 104
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We asked, you answered: More global buzzwords for 2023, from precariat to solastalgia

NPR Health - Shots

After we published our list of terms likely to loom large in this year's vocabulary, readers submitted their own nominations. Here's a sampling.

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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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Wearable tech, AI and clinical teams join to change the face of trial monitoring

Medical Xpress

A multi-disciplinary team of researchers has developed a way to monitor the progression of movement disorders using motion capture technology and AI.

Trials 111
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FDORA Enacted; HP&M Issues Detailed Summary and Analysis

FDA Law Blog

On December 29, 2022, the President signed into law the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act, 2023 , Pub. L. No. 117-328 (2022). FDORA primarily amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The law enacts significant changes that will have considerable short- and long- term effects on the regulated industry and the FDA.

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Steps we can take to combat COVID in 2023

Medical Xpress

Despite everyone wanting 2023 to be the year we go "back to normal," the COVID-19 pandemic is still with us, and with open borders, increased travel and new variants appearing, decision-makers face further challenges in deciding what policies to implement, and when, in the face of an uncertain future.

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Effect of Disposable Elevator Cap Duodenoscopes on Microbial Contamination and Technical Performance of ERCP

JAMA Internal Medicine

This randomized clinical trial determines contamination rates after high-level disinfection and technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs.

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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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Which pharmaceutical companies have the greatest global patent coverage?

Drug Patent Watch

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

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How can pharma teams optimise their HCP portals to strengthen HCP relationships and impact patient outcomes?

pharmaphorum

In recent years, pharma companies have invested heavily in their healthcare provider (HCP) portals, along with other digital solutions, to account for the reduction in face-to-face time between reps and HCPs during and post-pandemic. While the concept of HCP portals is a good one, the perception and impact has sometimes been underwhelming. Many organisations report low engagement amongst HCPs, and HCPs themselves talk of frustrations when it comes to utilising pharma-sponsored portals.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow.

Drugs 317