Sat.Dec 31, 2022 - Fri.Jan 06, 2023

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10 clinical trials to watch in the first half of 2023

Bio Pharma Dive

By the end of June, highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.

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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.

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FDA approves Alzheimer's drug that appears to modestly slow disease

NPR Health - Shots

An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.

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For people with disabilities, reproductive health care comes with deep-rooted barriers

STAT News

Pregnancy, for the average person, is an exercise of extremes — swelling body, welling emotions, surging hormones. For people with chronic conditions and other disabilities, the experience can be even more jarring, full of additional barriers, stigma, and risks. But it’s not just pregnancy. In the United States, disabled people are less likely to be taught comprehensive sexual education and given access to contraceptives, and are more likely to have unintended pregnancies.

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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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FDA approves Alzheimer’s drug from Eisai, Biogen in closely watched decision

Bio Pharma Dive

The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.

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Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Pharmaceutical Technology

Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

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STAT+: The health tech tracker for 2023’s first quarter: 12 industry events to watch

STAT News

Continuing economic uncertainty and the threat of a recession are casting a pall over health tech in 2023 — a dramatic shift for an industry that enjoyed abundant funding in the pandemic’s early stages. Last quarter’s string of layoffs at companies like Ro, Noom and ThirtyMadison portend tight budgets and conservative contracts this year, with employers unsure about which digital offerings actually drive down health care costs for workers.

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Eisai, in pricing new Alzheimer’s drug, tries to sidestep controversy

Bio Pharma Dive

The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness.

Drugs 325
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Good hydration linked to healthy aging

Medical Xpress

Adults who stay well-hydrated appear to be healthier, develop fewer chronic conditions, such as heart and lung disease, and live longer than those who may not get sufficient fluids, according to a National Institutes of Health study published in eBioMedicine.     Using health data gathered from 11,255 adults over a 30-year period, researchers analyzed links between serum sodium levels—which go up when fluid intake goes down—and various indicators of health.

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RSV recedes and flu peaks as a new COVID variant shoots 'up like a rocket'

NPR Health - Shots

RSV and the flu appear to be receding in the U.S., but COVID is on the rise, new data suggests, driven by holiday gatherings and an even more transmissible omicron subvariant that has become dominant.

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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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Opinion: NIH advances landmark recommendations on disability inclusion and anti-ableism

STAT News

A diverse and inclusive workforce benefits science and research. But unless it includes people living with a disability — the largest minority group in the U.S. and around the world — research will never be fully representative and science will not reach its full potential. Although 27% of U.S. adults live with a disability, only 10% of science, engineering, and health doctorate holders, and less than 2% of researchers funded by the National Institutes of Health, report having a di

Engineer 142
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Prevail, Capsida partner to develop gene therapies for nervous system diseases

Bio Pharma Dive

The Lilly-owned subsidiary will pay $55 million to gain access to Capsida’s AAV gene therapy technology in a deal aimed at central nervous system disorders.

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Dry eye disease alters how the eye's cornea heals itself after injury

Medical Xpress

People with a condition known as dry eye disease are more likely than those with healthy eyes to suffer injuries to their corneas. Studying mice, researchers at Washington University School of Medicine in St. Louis have found that proteins made by stem cells that regenerate the cornea may be new targets for treating and preventing such injuries.

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Many ERs offer minimal care for miscarriage. One group wants that to change

NPR Health - Shots

A group of doctors trains health care providers to treat miscarriage in the emergency department. This could be increasingly important in states where abortion is outlawed.

Doctors 143
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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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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

Research 137
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Fate, two other cell therapy biotechs lay off staff, restructure research

Bio Pharma Dive

The cuts at Fate, Century Therapeutics and TCR2 Therapeutics signal a longer road in the companies’ plans to develop next-generation cell therapies for cancer.

Research 306
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STAT+: Fate Therapeutics plans mass layoffs, after early end to cell therapy deal with Janssen

STAT News

SAN DIEGO — Fate Therapeutics, a biotech upstart with big ambitions to use cell-based therapies to treat autoimmune diseases and cancer, is now planning to cut back on both jobs and experimental drugs after an early end to a deal with Janssen. The setback, announced Thursday, will cut the company’s size to 220 workers by the end of the first quarter of this year.

Drugs 134
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How our perception of time shapes our approach to climate change

NPR Health - Shots

Climate goals can feel distant. But climate change is a happening right now. Speed up the benefits for taking action, psychologists say, if you want leaders and others to pay attention and act.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Inflammatory trigger a new clue in Alzheimer's

Medical Xpress

Scientists from The University of Texas Health Science Center at San Antonio (UT Health San Antonio) today reported that an inflammatory trigger like one present during viral infections is elevated in Alzheimer's disease and progressive supranuclear palsy, a rare brain disorder.

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Novocure shares soar on positive lung cancer data

Bio Pharma Dive

A regimen involving the Swiss biotech’s electrical field-based treatment extended lives in a late-stage trial. But data comparing the medical device to standard chemotherapy is less persuasive.

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Walgreens to pursue certification to provide abortion pills in pharmacies

STAT News

Walgreens plans to seek certification to begin providing abortion pills under new Food and Drug Administration rules that allow the drugs to be distributed by retail pharmacies, the company told STAT on Wednesday.  “We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws,

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Did Damar Hamlin experience commotio cordis? What to know about the rare phenomenon

NPR Health - Shots

It involves the impact of a specific force to the chest at a specific moment in the cardiac cycle. One cardiologist told NPR that what happened to Hamlin was likely "a perfect storm of events.

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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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Duping antibodies with a decoy, researchers aim to prevent rejection of transplanted cells

Medical Xpress

Researchers at UCSF have developed a novel, potentially life-saving approach that may prevent antibodies from triggering immune rejection of engineered therapeutic and transplant cells.

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Moderna, becoming a buyer, acquires a synthetic biology specialist

Bio Pharma Dive

The biotech said its first acquisition, an $85 million purchase of Japanese company OriCiro Genomics, will hand it better tools to make a key building block of messenger RNA.

RNA 294
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STAT+: The FDA has approved a new Alzheimer’s drug, but wide access may depend on CMS easing restrictions

STAT News

Now that the U.S. Food and Drug Administration has granted accelerated approval to the widely anticipated Alzheimer’s drug from Eisai and Biogen, a key question is the extent to which payers — private and public — will cover the treatment. Such decisions are based on myriad factors, starting with the average $26,500 price tag. But there are other considerations, including the quality of the clinical trial data, side effect concerns, the patient population for which the medic

Drugs 119
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Short on community health workers, a county trains teens as youth ambassadors

NPR Health - Shots

In Fairfax County, Va., the health department is training high school students to become health ambassadors in underserved communities and get a leg up on future careers in public health.

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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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New study challenges previous ideas regarding Alzheimer's disease

Medical Xpress

A new USC Leonard Davis School of Gerontology study challenges existing ideas of how buildup of a protein called amyloid beta (Aβ) in the brain is related to Alzheimer's disease.

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Bluebird bolsters balance sheet with sale of second regulatory fast pass

Bio Pharma Dive

The gene therapy developer will receive $95 million from Bristol Myers Squibb, slightly less than it got in the recent sale of another priority review voucher.

Sales 305
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Officials in Nebraska, South Dakota, Oklahoma begin to probe prisons’ hepatitis C treatment efforts

STAT News

WASHINGTON — Members of Congress, state legislators, regulators, and legal advocates are calling on prisons to explain their poor hepatitis C treatment rates, after a STAT investigation revealing that more than 1,000 people had died from complications of the curable disease. In South Dakota and Oklahoma, lawmakers have written to their respective departments of corrections about STAT’s reporting.

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Abortion pills should be easier to get. That doesn't mean that they will be

NPR Health - Shots

Changes by the FDA mean patients won't have to schedule in-person exams to get a prescription. That opens the door for more pharmacies to provide the medication. But not everyone will have access.

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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.