February, 2023

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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.

Drugs 363
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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology.

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Getting Rid of a Chronic Cough Is Tougher Than You Think

AuroBlog - Aurous Healthcare Clinical Trials blog

When was the last time you walked into a public space and didn’t hear someone coughing? After three years of flinching at the sound, it can be disarming to hear so many people coughing – and embarrassing if it’s you. But take heart in knowing that you’re not alone.

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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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What does the science say about the origin of the SARS-CoV-2 pandemic?

NPR Health - Shots

Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.

Scientist 145
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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

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Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly.

Marketing 360
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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Vaccine 293
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Inhaling Car Fumes Can Change a Brain’s Connectivity in Just 2 Hours, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Breathing in air pollution could have an impact on the way your brain is wired, with scientists at the University of British Columbia (UBC) and the University of Victoria discovering that inhaling car exhaust can change a brain’s connectivity within two hours.

Scientist 244
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Parents raise concerns as Florida bans gender-affirming care for trans kids

NPR Health - Shots

Florida's medical boards have voted to ban gender-affirming care for transgender youth. Families with trans children and medical providers who care for them are worried about the impact.

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

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Current treatments for cramps aren’t cutting it. Why aren’t there better options?

STAT News

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

Research 145
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Humans don't hibernate, but we still need more winter sleep

Medical Xpress

Whether we're night owls or morning larks, our body clocks are set by the sun. Theoretically, changing day length and light exposure over the course of the year could affect the duration and quality of our sleep. But figuring out how this applies in practice is difficult. Although studies where people assess their own sleep have suggested an increase in sleep duration during winter, objective measures are needed to determine how exactly the seasons affect sleep.

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Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine.

Vaccine 358
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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

Vaccine 289
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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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Study of 500,000 Medical Records Links Viruses to Alzheimer’s Again And Again

AuroBlog - Aurous Healthcare Clinical Trials blog

A study of around 500,000 medical records has suggested that severe viral infections like encephalitis and pneumonia increase the risk of neurodegenerative diseases like Parkinson’s and Alzheimer’s. Researchers found 22 connections between viral infections and neurodegenerative conditions in the study of around 450,000 people.

Research 244
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Actor Bruce Willis has frontotemporal dementia. Here's what to know about the disease

NPR Health - Shots

Willis family announced Thursday that his previous diagnosis of aphasia has progressed to frontotemporal dementia. The disease can cause issues with speaking and writing.

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STAT+: In about-face, Moderna vows Americans won’t have to pay for its Covid-19 vaccine

STAT News

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

Vaccine 145
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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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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 to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

Vaccine 357
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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

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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 244
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ERs staffed by private equity firms aim to cut costs by hiring fewer doctors

NPR Health - Shots

Increasingly, private equity firms shape staffing decisions at hospital emergency rooms, research shows. One apparent effect: Hiring fewer doctors and more health care practitioners who earn far less.

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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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Study finds mushrooms magnify memory by boosting nerve growth

Medical Xpress

Researchers from The University of Queensland have discovered the active compound from an edible mushroom that boosts nerve growth and enhances memory.

Research 145
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Opinion: Disruptive science is leaping forward, not limping along

STAT News

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

Scientist 145
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New cancer cell therapy biotech emerges, backed by MD Anderson and Replay

Bio Pharma Dive

Syena will develop TCR-based natural killer cell therapies, building on research done by MD Anderson’s Katy Revzani and using technology from Replay.

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How epilepsy researchers are moving the needle past anti-seizure treatments

Pharmaceutical Technology

While several therapeutics are available for treating symptoms associated with epilepsy, researchers and patients have strongly called out the need for more holistic treatments that would address the condition as a whole. Although recently approved drugs can treat seizures more safely, they do not treat the comorbidities that patients experience. Several biotech companies and researchers are now exploring medical devices and gene therapies to address not just common forms of epilepsy, but also r

Research 264
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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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Beetroot Really Can Boost Athletic Performance, And This Is Why

AuroBlog - Aurous Healthcare Clinical Trials blog

Beetroot is gaining popularity as a performance-enhancer for athletes and those wanting to gain a competitive advantage in running and cycling. Some people juice beetroot, some eat it, others mix up a drink from the powdered form.

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As the pandemic ebbs, an influential COVID tracker shuts down

NPR Health - Shots

After three years, the Johns Hopkins Coronavirus Resource Center is ceasing operations. Its data dashboards and maps became go-to sources for information from the early days of the pandemic.

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The possible effects of cinnamon on memory and learning

Medical Xpress

Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.

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Opinion: The haunting brain science of long Covid

STAT News

Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.

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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