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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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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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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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

Last week, Novartis announced plans to pay $245 million to end a pay-for-delay legal battle that started in 2018. This settlement ends a packed year of legal rulings for the Swiss pharmaceutical giant. In this most recent settlement, the drug company faced allegations of colluding with the generics company Par Pharmaceuticals to violate antitrust laws.

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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 329
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China’s NMPA clears Transcenta’s IND for solid tumour treatment

Pharmaceutical Technology

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody. It has demonstrated better single-agent activities in patient-derived xenograft tumour models of many difficult-to-treat solid tumours, including microsatellite stable colorectal cancer and castration-resistan

Antibody 242
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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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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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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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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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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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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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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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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

Medicine 142
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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 312
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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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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.

Medicine 137
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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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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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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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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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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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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.

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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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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.

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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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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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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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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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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.

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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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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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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!