Fri.Dec 23, 2022

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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year. This alliance is utilising the Axiomer ribonucleic acid (RNA) editing platform of ProQR to address ailments affecting the liver and nervous system.

Genetics 328
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Why have 1.7 million Somalis fled their homes? And is the world doing enough to help?

NPR Health - Shots

Dusty camps of displaced people have sprung up on the outskirts of cities. They ran from their homes because of drought, famine and fighting that involves the militant group al-Shabaab.

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FDA grants approval for Gilead’s multi-drug resistant HIV-1 treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. The treatment is indicated for adult patients who are heavily treatment-experienced (HTE) with multi-drug resistant (MDR) HIV-1 infection. This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacap

Drugs 147
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Flu activity in the U.S. continues to decline after early surge

STAT News

Flu activity across the United States continues to decline, though it remains at high levels in most parts of the country, the Centers for Disease Control and Prevention reported Friday in its weekly influenza update for the week ending Dec. 17. The percentage of people seeking medical care for influenza-like illness dropped for the third straight week, and hospitalizations due to flu declined for the second week in a row.

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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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Merck and Kelun-Biotech enter ADC development deal

Pharmaceutical Technology

Merck (MSD outside North America) has signed an exclusive licence and partnership agreement with Kelun-Biotech for developing seven investigational preclinical antibody-drug conjugates (ADC) to treat cancer. As per the deal, Merck will receive exclusive international licences from Kelun-Biotech for carrying out the research, development, production and marketing of these ADC therapies.

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A new kind of blood test can screen for many cancers — as some pregnant people learn

NPR Health - Shots

Testing pregnant people's blood to look at free-floating DNA can tell doctors about the health of the fetus. But these tests sometime turn up DNA that might be shed by cancerous cells.

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FDA changes Plan B label to clarify 'morning-after' pill doesn't cause abortion

NPR Health - Shots

The agency in a memo Friday said the emergency contraception pills are not the same as abortion pills — which end a pregnancy — a fact that has long been understood in the medical community.

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California medical school apologizes for unethical prisoner experiments

STAT News

SAN FRANCISCO — A prominent California medical school has apologized for conducting dozens of unethical medical experiments on at least 2,600 incarcerated men in the 1960s and 1970s, including putting pesticides and herbicides on the men’s skin and injecting it into their veins. Two dermatologists at the University of California, San Francisco — one of whom remains at the university — conducted the experiments on men at the California Medical Facility, a prison hospit

Research 116
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Target recalls weighted blankets after reports of 2 girls suffocating under one

NPR Health - Shots

The U.S. Consumer Product Safety Commission is recalling about 204,000 of the children's weighted blankets, which were being exclusively sold at Target. (Image credit: U.S.

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Study identifies key neurons that maintain normal body temperature in mammals

Medical Xpress

A research group at Nagoya University in Japan has reported that a group of neurons, called EP3 neurons, in the preoptic area of the brain play a key role in regulating body temperature in mammals. The finding could pave the way for the development of a technology that artificially adjusts body temperature to help treat heat stroke, hypothermia, and even obesity.

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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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Why does the U.S. government lock medicine away in secret warehouses?

NPR Health - Shots

Launched in 1999, the Strategic National Stockpile squirrels away huge quantities of medicine and medical supplies in case a mass outbreak or other health crisis occurs. (Image credit: U.S.

Medicine 121
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Opinion: Allowing pharmacies to dispense methadone is dangerous for patients and communities

STAT News

Congress is expected to pass a massive $1.7 trillion omnibus spending package that includes numerous provisions aimed at addressing the opioid epidemic. I have been advocating for greater access to opioid addiction treatment for more than two decades. While the spending package contains many positive opioid treatment reforms, I am deeply concerned that Congress and others without on-the-ground experience will continue pushing dangerous policies to solve the opioid epidemic in the next Congress.

Pharmacy 111
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Greater exercise activity is tied to less severe COVID-19 outcomes, a study shows

NPR Health - Shots

A team of researchers' study suggests that COVID-19 health leaders incorporate exercise into their mitigation strategies.

Research 145
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Increasingly under fire as potential health hazards, gas stoves could be banned in 2023

Medical Xpress

Citing studies that link gas stoves to health problems, including asthma in children, a U.S. Consumer Product Safety Commission official said his agency will begin a formal review process that could lead to new regulations.

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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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Fears of a 'dark COVID winter' in rural China grow as the holiday rush begins

NPR Health - Shots

Health officials are concerned that people traveling home to their villages for the Lunar New Year could turn celebrations into superspreader events, catching ill-prepared rural systems off guard.

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New FDA guidance explains that Plan B is not an abortion pill

STAT News

The Food and Drug Administration on Friday altered the language attached to emergency contraceptive pills to clarify that they are not abortion drugs. The agency’s update eliminates previous language that had suggested that the over-the-counter products, commonly described as morning-after pills or Plan B, could prevent a fertilized egg from implanting in the uterus.

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Editors' pick: 8 great global stories from 2022 you might have missed

NPR Health - Shots

You'll read about a Kenyan ice sculptor, the risks to women from food insecurity, a poignant street encounter — and goats locking horns with sheep in a changing climate. (Image credit: Forest P.

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STAT+: Parker Institute extends ‘crazy idea’ funding to two more cancer centers

STAT News

With his Parker Institute for Cancer Immunotherapy, Sean Parker has been building a dream team of cancer researchers. Since 2016, the Parker Institute — known as PICI for short — has poured hundreds of millions of dollars into six research centers that it’s created at some of the top academic institutions in the country and folded luminaries like the CAR-T pioneer Carl June and Nobel Prize winner Jim Allison into its network.

Scientist 105
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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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When the body's B cell training grounds stay open after hours

Medical Xpress

If B cells are the munitions factories of the immune system, manufacturing antibodies to neutralize harmful pathogens, then the tiny biological structures known as germinal centers are its weapons-development facilities. Formed in response to infection and vaccination, these microscopic training grounds allow B cells to perfect the antibodies they deploy against specific viruses and bacteria.

Bacteria 105
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7 commercial, sales, and marketing predictions for 2023

pharmaphorum

In 2022, life sciences companies have been hard at work breaking down silos to better serve patients and healthcare professionals (HCPs). They’ve laid the necessary groundwork for cross-functional visibility, collaboration, and connectivity. And in 2023, these investments will hopefully pay off. Here are seven commercial predictions from Veeva’s industry experts for the year ahead.

Sales 103
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Leaving 'bah humbug' behind: A psychological phenomenon

Medical Xpress

It's a tale celebrated across generations each holiday season. A grouchy rich man named Ebenezer Scrooge learns the true meaning of Christmas, after a supernatural encounter on Christmas Eve. Yet, beyond the three ghosts and Tiny Tim, "A Christmas Carol" is the basis for an unexplored psychological phenomenon.

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STAT+: Pharmalittle: FDA approves a Genentech blood-cancer drug; Sean Parker expands his immunotherapy research empire

STAT News

Good morning, Pharmalittle family! Your loyal scribe Ed Silverman is taking today off, so he bestowed upon me, Adam Feuerstein, the great honor of delivering today’s roundup of pharma news. But first, my coffee: Intelligentsia House Blend, brewed in a Chemex. Old school. Hints of apple, citrus, and milk chocolate. Or, so they say. To me, it just tastes like a really good cup of joe on a stormy Friday morning.

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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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How the brain stores remote fear memory

Medical Xpress

A remote fear memory is a memory of traumatic events that occurred in the distant past—a few months to decades ago. A University of California, Riverside, mouse study published in Nature Neuroscience has now spelled out the fundamental mechanisms by which the brain consolidates remote fear memories.

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The winter holidays are once again colliding with a surge in illnesses

NPR Health - Shots

NPR's Leila Fadel talks to Dr. Ashish Jha, White House COVID Response coordinator, about COVID, flu, RSV and what Americans need to know to stay healthy during the holiday season.

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Tumor ammonia levels inhibit T cell growth, impact immunotherapy: Study

Medical Xpress

High levels of ammonia in tumors leads to fewer T cells and immunotherapy resistance in mouse models of colorectal cancer, new findings from the University of Michigan Rogel Cancer Center revealed. Researchers found that ammonia inhibits the growth and function of T cells, which are vital for anti-tumor immunity. The findings appear in Cell Metabolism.

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New patent expiration for Eagle Pharms drug RYANODEX

Drug Patent Watch

Annual Drug Patent Expirations for RYANODEX Ryanodex is a drug marketed by Eagle Pharms and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent expiration for Eagle Pharms drug RYANODEX appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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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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'A very hard road ahead' for China as COVID-19 cases spiral

Medical Xpress

Nearly three years after it was first identified in China, the coronavirus is now spreading through the vast country. Experts predict difficult months ahead for its 1.4 billion people.

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EVERSANA INTOUCH Gets Together for Winter Gatherings

Intouch Solutions

At EVERSANA INTOUCH, we value building lasting relationships both in-person and virtually. Recently, each of our office locations hosted in-person winter gatherings to celebrate the year and festive season. The gatherings included: food, drinks, philanthropic giving opportunities, a photo booth, cookie and ornament decorating and most importantly, the company of coworkers!

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Diagnostics can advance health sustainable development goals in Asia Pacific

Medical Xpress

We are at the halfway point from when we set our ambitious sustainable development goal 3 (SDG3) for good health and well-being by 2030. While many agree we were making progress towards this goal, no one could have foreseen that we would be facing major disruptions from a pandemic.

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Pistoia Alliance tackles lack of diversity in pharma  

Drug Discovery World

The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has expanded its popular Women in STEM Leadership Programme to include other underrepresented communities in a new 2023 initiative. . The three-month programme brings together leaders from life science and large pharmaceutical companies to offer an opportunity for participants to network and learn how they can better support D&I initiatives within their teams and compa

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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.