January, 2023

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

Big Data 303
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Biotech CFOs eye research cuts, partnerships amid sector retrenchment: report

Bio Pharma Dive

The report, a yearly poll of 100 financing executives by accounting and consulting firm BDO, revealed the many levers young drugmakers are pulling to conserve cash.

Research 341
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Pharma Mirror Q&A with Jane Myles, Vice President of Clinical Trial Innovation at Curebase

Pharma Mirror

The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11. This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.

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Our Body Temps Have Been Dropping For 160 Years. Gut Microbes May Be Playing a Role

AuroBlog - Aurous Healthcare Clinical Trials blog

The average temperature of the human body has been steadily declining since the middle of the 19th century, and scientists aren’t sure why. A new study suggests one key factor that might play a role in this: gut microbes.

Scientist 246
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT News

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

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FDA considers major shift in COVID vaccine strategy

NPR Health - Shots

The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.

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Large study of J&J’s HIV vaccine stopped after shot found ineffective

Bio Pharma Dive

The result from the nearly 4,000-person trial is the latest setback in a long-running effort to develop a safe and effective shot for HIV infections.

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Anti-aging gene shown to rewind heart age by ten years

Medical Xpress

An anti-aging gene discovered in a population of centenarians has been shown to rewind the heart's biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.

Gene 145
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There’s a Simple Way to Offset The Health Risks of Sitting All Day

AuroBlog - Aurous Healthcare Clinical Trials blog

To reduce the harmful health effects of sitting, take a 5-minute light walk every half-hour. That’s the key finding of a new study that my colleagues and I published in the journal Medicine & Science in Sports & Exercise. We asked 11 healthy middle-aged and older adults to sit in our lab for 8 hours […].

Medicine 246
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STAT+: Pfizer is scolded by a U.K. trade group for remarks its CEO made about vaccination

STAT News

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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The FDA no longer requires all drugs to be tested on animals before human trials

NPR Health - Shots

In a victory for animal rights advocates, drugmakers can take their products to human clinical trials using alternative testing methods that don't involve animals.

Trials 145
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CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

Medicine 298
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5 FDA decisions to watch in the first quarter

Bio Pharma Dive

An Alzheimer’s drug from Eli Lilly, BioMarin’s hemophilia gene therapy and a new type of breast cancer treatment are among the top decisions on the agency’s docket through the end of March.

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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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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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COVID Autopsies Reveal The Virus Spreading Through The ‘Entire Body’

AuroBlog - Aurous Healthcare Clinical Trials blog

COVID-19 is defined as a respiratory infection, but the effects of the novel coronavirus are certainly not confined to any one organ. Dozens of recent autopsies show persistent evidence of SARS-CoV-2 throughout the body, including in the lungs, the heart, the spleen, the kidneys, the liver, the colon, the thorax, muscles, nerves, the reproductive tract, […].

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HIV vaccine being developed by Johnson & Johnson fails clinical trial

STAT News

Yet another experimental HIV vaccine has failed. The National Institute of Allergy and Infectious Diseases reported Wednesday that a Phase 3 clinical trial of a vaccine was stopped because the vaccine was ineffective at preventing HIV infection. The vaccine was being developed by Janssen, the vaccine division of Johnson & Johnson.

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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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Are we entering the era of biologics for COPD?

Pharmaceutical Technology

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Approaches like bronchodilator inhalers focus on treating both asthma and chronic obstructive pulmonary disease (COPD).

Antibody 298
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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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Three VCs launch Dimension, a new firm with plans to fuel biotech’s ‘digitization’

Bio Pharma Dive

The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.

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BMS settles lawsuit with two fired employees who refused COVID vaccines

Fierce Pharma

BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30

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Hypertension Drug Shown to Extend Lifespan And Slow Aging in Animals

AuroBlog - Aurous Healthcare Clinical Trials blog

The hypertension drug rilmenidine has been shown to slow down aging in worms, an effect that in humans could hypothetically help us live longer and keep us healthier in our latter years. Rilmenidine was picked for this latest study because past research has shown it mimics the effects of caloric restriction on a cellular level.

Drugs 244
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Routine vaccinations drop among U.S. kindergartners for the third year in a row

STAT News

The percentage of U.S. kindergartners who’ve received standard childhood vaccines took a small but notable dip into the 2021-2022 school year, health officials said Thursday, amid disruptions related to Covid-19 and fears that anti-vaccine sentiment stirred up by the pandemic could be spreading to other shots. Vaccinations among children remain high, but the trend — with coverage dropping from about 95% in the 2019-2020 school year to 94% in 2020-2021 to 93% in 2021-2022, according

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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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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.

Protein 145
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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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JPM23: Califf on accelerated approvals, biotech startups’ looming cliff and an explanation from Editas

Bio Pharma Dive

The FDA commissioner shared advice for drugmakers at the J.P. Morgan Healthcare conference, while venture investors cautioned of a coming funding crunch for young biotechs.

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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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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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Pets Help to Protect Your Brain as You Get Older, Study Suggests

AuroBlog - Aurous Healthcare Clinical Trials blog

Sometimes what’s good for your heart is also good for your brain. A recent study of US adults over 50 found that those who owned a pet for more than five years scored better on cognitive memory tests than those living without interspecies housemates. The findings from the University of Michigan suggest the ‘pet effect‘ […].

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For most mild infections, long Covid symptoms clear after a year, large study finds

STAT News

Since long Covid emerged, how best to define it, predict it, and treat it has been up for debate, but perhaps the most urgent question for patients and providers alike has been how long it lasts. A new study analyzing nearly 2 million patient records in Israel concludes that for most people, the troubling symptoms that persist after a mild Covid infection fade away after about a year.

Scientist 145
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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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Current and future players in the lupus market

Pharmaceutical Technology

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).

Marketing 278
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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