Mon.Feb 13, 2023

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US agrees to buy more doses of Novavax’s COVID shot

Bio Pharma Dive

The company said its modified contract with the federal government, which comes ahead of a planned transition to private market sales, will help it develop an updated version of its vaccine.

Sales 342
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Your Blood Type Affects Your Risk of Early Stroke, Scientists Find

AuroBlog - Aurous Healthcare Clinical Trials blog

People with one of the type A blood groups are more likely to have a stroke before the age of 60 compared with people with other blood types, research shows. Blood types describe the rich variety of chemicals displayed on the surface of our red blood cells.

Scientist 200
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Sanofi’s R&D head John Reed to step down

Bio Pharma Dive

Reed, who is leaving for a “new opportunity outside Sanofi,” oversaw the recent transformation of the French company’s pipeline of drug programs.

Drugs 286
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Pfizer’s sNDA for Cibinqo receives FDA approval for atopic dermatitis

Pharmaceutical Technology

Pfizer has received the US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Cibinqo (abrocitinib) to treat a type of atopic dermatitis (AD). The latest approval expands Cibinqo’s indication to include adolescents aged 12 to 18 years with refractory, moderate-to-severe AD, for whom other systemic drugs are ineffective, or the use of those therapies is not advisable.

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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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Changing the trajectory of blood cancers with transformational and potentially curative therapies at ASH

Bio Pharma Dive

Janssen Oncology reflects on advancements in hematology after attending the 2022 American Society of Hematology (ASH) Annual Meeting.

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TN DCA issues circular asking pharmacists in medical shops to wear white coat and badges

AuroBlog - Aurous Healthcare Clinical Trials blog

Although provisions of the Pharmacy Practice Regulations (PPR) 2015 are not there in the Drugs and Cosmetics (D&C) Act 1940 but are framed under the Pharmacy Act 1948, the steps now being taken by the drugs control administration (DCA) in Tamil Nadu in a motive to strengthen the dispensing activities in pharmacies are completely agreeing […]

Cosmetics 153

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SOPHiA GENETICS and AstraZeneca partner for oncology drugs development

Pharmaceutical Technology

SOPHiA GENETICS is expanding its collaboration with AstraZeneca to include multimodal approaches for developing cancer drugs. This collaboration aims to use the global SOPHiA DDM platform, a cloud-native platform of SOPHiA GENETICS, and multimodal algorithmic capabilities for AstraZeneca’s oncology portfolio. SOPHiA GENETICS’ platform can analyse data and produce insights from complex multimodal data sets and different diagnostic modalities.

Genetics 130
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Analyze whole genome sequencing samples at the speed of light

Bio Pharma Dive

Deliver fast and reliable results at low cost with a tool for whole genome analysis in just minutes

Genome 246
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Scilex buys rights to acute migraine treatment Elyxyb in Canada and the US

Pharmaceutical Technology

Sorrento Therapeutics’ majority-owned subsidiary Scilex has acquired rights to Elyxyb (celecoxib) oral solution in Canada and the US. Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Study suggests fructose could drive Alzheimer's disease

Medical Xpress

An ancient human foraging instinct, fueled by fructose production in the brain, may hold clues to the development and possible treatment of Alzheimer's disease (AD), according to researchers at the University of Colorado Anschutz Medical Campus.

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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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Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

Rethinking Clinical Trials

                                           Speaker Luregn Schlapbach, PhD, FCICM Head, Department of Intensive Care and Neonatology University Children`s Hospital, Zurich Zurich, Switzerland The University of Queensland Brisbane, Australia Slides Keywords Pediatric, Pragmatic Clinical Trial, Congenital Heart Disease Key Points The focus of the NITRIC file was on congenital heart disease, which affects about 1 in 100 newborn children with 25 percent requ

Trials 130
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'Dr. Lisa on the street' busts health myths and empowers patients

NPR Health - Shots

She's seen what happens when people don't trust or understand their doctor. Dr. Lisa Fitzpatrick founded 'Grapevine Health' to get solid information out, especially to Black and Latinx patients.

Doctors 121
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Survey: Nearly 3 in 5 teen girls felt persistently sad or hopeless in 2021

STAT News

Teen girls reported record levels of violence, sadness, and thoughts of suicide in 2021, experiencing distress at twice the rate of teen boys, according to new federal data released Monday. The nearly 3 in 5 teen girls who felt persistently sad or hopeless in 2021 was a 60% increase compared to a decade earlier.

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Sniffer dogs offer hope in waning rescue efforts in Turkey

NPR Health - Shots

Days after the Feb. 6 earthquake in Turkey and Syria, hopes of finding people alive is waning. One U.S.-based team uses search-and-rescue dogs to try to find people still trapped days after the quake.

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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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Patients still have no protection against surprise ambulance bills. And there’s no solution in sight

STAT News

One night in November 2021, 11 weeks into her pregnancy, Carolyn Provine started bleeding — a lot. When she passed out, her wife and mother-in-law called an ambulance and drove 21 miles to the hospital for an emergency surgery. But the hemorrhaging, and miscarriage, no longer were Provine’s only concerns. “My first thought was, ‘Wait, is there some way for me not to take an ambulance?

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Teen girls and LGBTQ+ youth plagued by violence and trauma, survey says

NPR Health - Shots

Nearly one in three girls reported seriously considering suicide in the past year – a 60% rise from a decade ago, according to the CDC survey data.

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Opinion: ChatGPT-assisted diagnosis: Is the future suddenly here?

STAT News

The notion that people will regularly use computers to diagnose their own illnesses has been discussed for decades. Of course, millions of people try to do that today, consulting Dr. Google , though often with little success. Given the low quality of many online health sources, such searches may even be harmful. Some governments have even launched “ Don’t Google It ” campaigns to urge people not to use the internet for health concerns.

Research 105
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Stress levels sky high for families of neurodiverse kids

Medical Xpress

New Curtin University-led research has found caregivers of neurodivergent children are more likely to experience clinically significant levels of stress, poor mental health, financial hardship, and negative relationships.

Research 109
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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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‘It is a balance’: Scientists grapple with ethics of cutting-edge stem cell research

STAT News

SAN DIEGO — When biologist Alysson Muotri started tinkering with tiny balls of nerve cells in the lab more than a decade ago, his goal was simply to understand early brain development and neurological disease. He didn’t realize he was stumbling into an ethical minefield. His University of California, San Diego team found that when human stem cells were grown into so-called brain organoids in the lab, these tiny 3D structures produced regular waves of electrical activity that resemb

Scientist 105
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Drug shown to alleviate autism-associated behavior in mice

Medical Xpress

The behavioral disorders observed in autism are associated with a multitude of genetic alterations. Scientists from the Hector Institute for Translational Brain Research (HITBR) have now found another molecular cause for this condition.

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Could a swallowable, quarter-sized device make diagnosing GI diseases less unpleasant?

STAT News

Diagnosing gastrointestinal disorders is an uncomfortable process. It might involve sticking a long tube with a camera attached down a patient’s throat, or inserting a small catheter through a patient’s nostril. A team of researchers from the Massachusetts Institute of Technology, the California Institute of Technology, and New York University, looking to explore more comfortable options, has designed an ingestible device that doctors can monitor as it moves through the GI tract.

Doctors 98
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Changes in how the heart produces energy may be the earliest signal of cardiac deterioration

Medical Xpress

Heart failure is often identified only when the heart has already deteriorated. This is in large part because the cause is unknown for about 70% of people who experience heart failure.

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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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Sen. Tammy Baldwin criticizes Ascension’s for-profit investment activities, requests returns and fees info

STAT News

WASHINGTON — Sen. Tammy Baldwin on Monday blasted Ascension for service cuts at hospitals in Wisconsin and questioned whether returns from the Catholic health system’s for-profit investments are actually being used to help patients. Baldwin wrote a letter addressed to Ascension that cites STAT reporting about the extent of Ascension’s more than $1 billion in private equity investments alongside TowerBrook Capital Partners, including Ascension’s relationship with

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CBD may increase the adverse effects of THC in edible cannabis products, study shows

Medical Xpress

Contrary to some common claims, a study led by Johns Hopkins Medicine researchers has found that relatively high doses of cannabidiol (CBD) may increase the adverse effects of delta-9-tetrahydrocannabinol (THC), the main active ingredient in cannabis that can cause a mood alteration or a "high" sensation. The findings show that in edible cannabis products, CBD inhibits the metabolism, or breakdown, of THC, which may result in stronger and longer drug effects.

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Watch: Blockbuster drug Humira has new competition. Here’s why that matters

STAT News

Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita. Humira’s main patent expired in 2016, but a byzantine patent saga has kept other drugmakers from offering their own version of the monoclonal antibody used to treat conditions such as rheumatoid arthritis and Crohn’s disease.

Drugs 98
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Decades of conflict in Iraq have fueled 'catastrophic' rise in antibiotic resistance, warn experts

Medical Xpress

Decades of wars and conflict in Iraq have led to a "catastrophic" rise in antibiotic resistance in the country, with serious implications for the entire region and the world, warn international experts in the open access journal BMJ Global Health.

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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.

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Opinion: How you can inspire your clinicians to reduce health-care-generated climate change

STAT News

Almost everyone is a patient at some time. And even if the interaction with a doctor or nurse or other clinician is brief, it’s an opportunity to do something to fight climate change. The health care sector is responsible for 8.5% of all greenhouse gas emissions in the United States. To be sure, some of that comes from the amount of energy hospitals consume 24/7.

Nurses 98
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Coconut sugar may lower blood pressure, artery stiffness in older adults

Medical Xpress

A first-of-its-kind study finds a natural coconut sugar may help reduce the risk of cardiovascular disease by improving blood vessel health and managing high blood pressure. The study is published ahead of print in the Journal of Applied Physiology.

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STAT+: In another pharma shakeup, Sanofi loses top executive known for overhauling R&D

STAT News

Sanofi’s head of research and development, John Reed, is leaving the pharmaceutical giant to pursue a new opportunity, the company announced Monday. Reed joined Sanofi in 2018, after holding a similar position at Swiss pharma company Roche. Prior to that, he was the CEO of the Sanford-Burnham Medical Research Institute in La Jolla, Calif., and a leading researcher in cell biology.

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Conundrum solved over HPV link with head and neck cancer

Medical Xpress

A major international trial published in The Lancet Oncology has looked at studies from 13 head and neck cancer centers from nine countries around the world. Using the data of 7,895 patients, a research team has found that there is a significant number of people who have "discordant" results in which two different tests for HPV show different results.

Trials 98
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.