FDA Law Blog: Biosimilars

DECEMBER 4, 2023

By Larry K. Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. On October 10th, based on ability to pay, the U.S. District Court for the Western District of Texas imposed a $275,000 civil penalty on Zarzamora Healthcare LLC, in San Antonio, and its pharmacist-owner.

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Pharmacy Government Treatment Compliance 139

National Drug & Alcohol Research Centre Blog

DECEMBER 4, 2023

Kendal Chidwick NDARC’s Kendal Chidwick discusses the findings from a recently published study that examined how patterns of opioid agonist treatment medicines have changed over the past decade. In Australia, both methadone and buprenorphine have been subsidised by the Pharmaceutical Benefit Scheme (PBS) for the treatment of opioid dependence (termed ‘opioid agonist treatment’ or OAT) for several decades.

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Treatment Community Pharmacies Pharmacy International 133

keypoint

DECEMBER 4, 2023

Keystone Symposia is pleased to introduce the Keystone Symposia Fellows Class of 2024! This year we welcome seven early-career investigators and seven post-doctoral fellows, a new addition to the program this year.

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Doctors 131

Science Daily: Pharmacology News

DECEMBER 4, 2023

What wiped out the dinosaurs? A meteorite plummeting to Earth is only part of the story, a new study suggests. Climate change triggered by massive volcanic eruptions may have ultimately set the stage for the dinosaur extinction, challenging the traditional narrative that a meteorite alone delivered the final blow to the ancient giants.

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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

Treatment

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- As syphilis cases surge across America, a group representing the nation's STD specialists says members are reporting shortages of a drug essential to fighting the disease. In a survey from the National Coalition of STD.

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Drugs Disease 122

Science Daily: Pharmacology News

DECEMBER 4, 2023

Decreasing pancreatic beta cell numbers -- the only cells that produce insulin -- is a leading cause of diabetes. In a promising development, a research group has revealed that stimulating autonomic vagal nerves connected to the pancreas can improve the function and also increase the number of pancreatic beta cells in mice.

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Research 126

Science Daily: Pharmacology News

DECEMBER 4, 2023

Inspired by a small and slow snail, scientists have developed a robot protype that may one day scoop up microplastics from the surfaces of oceans, seas and lakes.

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Drug Target Review

DECEMBER 4, 2023

According to the Personalised Medicine Coalition , 34 percent of all new drugs approved by the US Food and Drug Administration (FDA) in 2022 are personalised medicines. What’s more, investment in this sector is predicted to rise by 70 percent by 2030. The reason for all this attention and investment is clear: significant benefits for patients. Tailoring medical care to a patient’s unique genetic makeup, alongside the close analysis of disease progression, leads to more effective treatments, redu

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Treatment Science DNA Doctors 105

Science Daily: Pharmacology News

DECEMBER 4, 2023

A star near the supermassive black hole at the center of the Milky Way Galaxy originated outside of the Galaxy according to a new study. This is the first time a star of extragalactic origin has been found in the vicinity of the super massive black hole.

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Perficient: Drug Development

DECEMBER 4, 2023

PowerShell proves highly useful in automating processes and managing various aspects of Sitecore. However, we faced difficulties when we encountered issues while importing files by using PowerShell Script. In this article we will discuss the file import issue which we encountered during a task in one of our projects. We encountered a scenario where we required to import data from an ‘Excel’ or ‘CSV’ file into ‘Sitecore’ We developed a PowerShell script to read

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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.

Clinical Trials

Science Daily: Pharmacology News

DECEMBER 4, 2023

Global warming can still be limited to 1.5°C by 2100 while ensuring that the poor are not hit hardest by climate policies and climate impacts. This is achieved by immediately introducing broad carbon pricing together with re-distributive policies using carbon pricing revenues and further measures to reduce energy consumption, accelerate technological transitions, and transform the land sector.

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BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

The biotech said Phase 2 study results showed its experimental medicine for age-related macular degeneration was "non-inferior" to Regeneron's Eylea.

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Drug Trials Trials Drugs 105

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- As syphilis cases surge across America, a group representing the nation's STD specialists says members are reporting shortages of a drug essential to fighting the disease.In a survey from the National Coalition of STD.

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Drugs 98

BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

The acquisition of Carmot, which had been planning an IPO, will hand Roche three weight loss medicines in early clinical testing.

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Drugs 117

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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

Clinical Trials

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- Women who enter menopause early could be at increased risk of muscle loss in their senior years, a new study suggests.Conversely, the more extended a woman’s reproductive period, the lower the risk of declining muscle mass.

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Science Daily: Pharmacology News

DECEMBER 4, 2023

Global carbon emissions from fossil fuels have risen again in 2023 -- reaching record levels, according to new research.

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Research 122

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- Gina Arata had a bright future, wrapping up college and preparing for law school, when a 2001 car wreck left her with lasting brain damage. After her recovery, Arata wound up taking a job sorting mail, but struggled even in.

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BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

Accurate and timely processing of data is imperative to create robust analytical datasets that can be used in the RWE setting.

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- Black men diagnosed with advanced prostate cancer are significantly less likely to be prescribed hormone therapy that could extend their lives, compared to other racial and ethnic groups, a new study shows.Studies have shown.

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keypoint

DECEMBER 4, 2023

Checkout the latest news & views from Keystone Symposia in our December 2023 Keypoint Newsletter, featuring Health Equity highlights, new 2-day meeting format, upcoming AI in Biomedicine virtual meeting & more!

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Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 -- Teenagers with epilepsy are more likely to have an eating disorder than those not suffering from the brain disease, a new study shows.About 8.4% of children ages 10 to 19 treated at a Boston epilepsy clinic had eating.

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Disease 97

BioPharma Drive: Drug Pricing

DECEMBER 4, 2023

With clinical trials becoming more complex, finding ways to streamline and automate laboratory processes is vital when analyzing bioanalytical samples.

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Clinical Trials Laboratories Trials 104

Science Daily: Pharmacology News

DECEMBER 4, 2023

Artificial intelligence tools hold promise for applications ranging from autonomous vehicles to the interpretation of medical images. However, a new study finds these AI tools are more vulnerable than previously thought to targeted attacks that effectively force AI systems to make bad decisions.

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SCIENMAG: Medicine & Health

DECEMBER 4, 2023

Researchers at Weill Cornell Medicine have found that controlling high blood pressure may not be enough to prevent associated cognitive declines. The findings point to an immune protein called cytokine IL-17 as a culprit for inducing dementia and suggest new approaches to prevent damage to brain cells.

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Research 92

Drugs.com

DECEMBER 4, 2023

MONDAY, Dec. 4, 2023 (Healthday News) -- While flu and COVID cases are now on the rise, RSV infections may soon peak and level off, U.S. health officials report.COVID-19 continues to fuel the most hospitalizations and deaths among all respiratory.

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Hospitals 96

keypoint

DECEMBER 4, 2023

In addition to covering emerging developments in vaccine science, design and technology, the Vaccinology During and After COVID-19 Keystone Symposium held in Atlanta on September 17-20, 2023, highlighted many aspects of health equity surrounding development and deployment of vaccines globally. Dr. Barney Graham, of Morehouse School of Medicine, set the stage for these conversations with his Keynote Address, which covered the current state of the field, future directions, and challenges in global

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Vaccine Science 88

Science Daily: Pharmacology News

DECEMBER 4, 2023

The prevailing assumption has been that Einstein's theory of gravity must be modified, or 'quantized', in order to fit within quantum theory. This is the approach of two leading candidates for a quantum theory of gravity, string theory and loop quantum gravity. But a new theory challenges that consensus and takes an alternative approach by suggesting that spacetime may be classical -- that is, not governed by quantum theory at all.

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Government 95

SCIENMAG: Medicine & Health

DECEMBER 4, 2023

Toronto, ON, December 4, 2023 – There was a disproportionate rise in pediatric eating disorder hospitalizations among males, younger adolescents, and individuals with eating disorder diagnoses other than anorexia or bulimia, according to a new study from researchers at The Hospital for Sick Children (SickKids) and ICES.

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Hospitals Research 84

Science Daily: Pharmacology News

DECEMBER 4, 2023

Scientists used weather radar data to map bird stopover density in the United States and found that artificial light is a top indicator of where birds will land. City lights lure birds into what can be an ecological trap -- with buildings that lead to collisions, less habitat, scarcer food, and more people and cats. The study provides the first continent-wide maps of migration stopover hotspots in the contiguous United States, and knowing these broadscale layover patterns can help in the develop

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SCIENMAG: Medicine & Health

DECEMBER 4, 2023

A study supported by the National Institutes of Health suggests that the response of immune system cells inside the protective covering surrounding the brain may contribute to the cognitive decline that can occur in a person with chronic high blood pressure.

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keypoint

DECEMBER 4, 2023

Keystone Symposia conferences hold a special place in science for their ability to drive interdisciplinary, innovative and transformative research that impacts the overall trajectory of science and medicine. What is the ‘special sauce’ behind our meeting programming that enables us to continually be on the forefront of new research frontiers? It is a community driven process that draws in thought-leaders across diverse expertise to collectively brainstorm, guide and finesse meeting programs that

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Science Research 80

SCIENMAG: Medicine & Health

DECEMBER 4, 2023

Washington D.C.—The December Health Affairs, a theme issue about the lessons learned around the globe from the COVID-19 pandemic, covers topics including how modeling was used to respond to the pandemic, how health inequities emerged and were addressed, and how countries tried to protect their vulnerable residents.

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Science Daily: Pharmacology News

DECEMBER 4, 2023

An entirely new way to probe how active black holes behave when they eat has been discovered by an international team of astronomers.

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International 94