August, 2022

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area.

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.

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What to look for when hiring in pharma

World of DTC Marketing

The great resignation has not affected pharma because the jobs within the industry pay very well and most positions and employees like the benefit of having a steady job with good money. However, some pharma companies are having problems filling open positions, and when they do, they often find it wasn’t a good fit. Here are some things to consider to ensure you’re hiring good people.

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The TB Vaccine Mysteriously Protects Against Lots of Things. Now We Know Why

AuroBlog - Aurous Healthcare Clinical Trials blog

When babies in the African countries of Guinea Bissau and Uganda were given the tuberculosis vaccine, something remarkable happened. Instead of the vaccine only protecting against the target bacteria – Myocbacterium tuberculosis – the tuberculosis vaccine offered broad protection against a range of unrelated infections, including respiratory infections and serious complications such as sepsis.

Vaccine 244
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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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Whatever happened to the new no-patent COVID vaccine touted as a global game changer?

NPR Health - Shots

The inventors of Corbevax said it was cheap, easy to make, effective and safe. They hoped it could bring vaccine equity to countries that can't access costlier shots. Has it lived up to its promise?

Vaccine 145
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U.S. life expectancy drops sharply, the second consecutive decline

STAT News

Americans born in 2021 can expect to live for just 76.1 years — the lowest life expectancy has been since 1996, according to a new government analysis published Wednesday. This is the biggest two-year decline — 2.7 years in total — in almost 100 years. The Covid-19 pandemic is the primary cause of the decline. However, increases in the number of people dying from overdoses and accidents is also a significant factor.

Research 145

More Trending

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Gilead’s Sunlenca receives EC approval to treat HIV

Pharmaceutical Technology

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. The twice-yearly treatment is indicated to be administered along with other antiretroviral(s) in adult patients with multi-drug resistant HIV infection who otherwise cannot have a suppressive anti-viral regimen.

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The futility of banner ads

World of DTC Marketing

Digital ad spending in the industry will reach $15.84 billion in 2022. Although growth in digital budgets is slowing, we estimate the category will see nearly $20 billion in spending in 2024. For every $1 million invested in online banner ads, just 0.1%, or $1,000, derives value for brands, resulting in $999,000 wasted by brands. So why is pharma wasting so much money?

Branding 270
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Experiment Restores Cell And Organ Functions to Dead Pigs, Hours After They Died

AuroBlog - Aurous Healthcare Clinical Trials blog

In mammals, blood carries oxygen and nutrients to the body’s organs and cells. But if blood flow stops, these cells will quickly die and organs are injured. This death can be slowed in organs and tissues removed from the body, buying time for organ transplantation. However, preserving entire organ systems minutes after the heart stops […].

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Life expectancy in the U.S. continues to drop, driven by COVID-19

NPR Health - Shots

Americans' life expectancy dropped for the second year in a row and is now the lowest it's been since the 1920s. COVID-19 is driving the downward trend, according to CDC data.

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

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Parents and clinicians say private equity’s profit fixation is short-changing kids with autism

STAT News

ATLANTA — When a new person comes into his living room, a giggly “E” smiles and passes a balloon her way. His fifth birthday was a few weeks ago, and these half-filled remnants still loiter around his suburban house. Suddenly, E darts upstairs for a moment alone, his wispy brown hair bouncing with each step.   There, in his room, is a corner with a tiny armchair, a short bookshelf, and a stuffed octopus.

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Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application.

Drugs 363
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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

On August 8, Pfizer and Valneva announced the initiation of a Phase III study with their Lyme disease vaccine , bringing the prospect of an injection to prevent the condition disease one step closer to reality. VLA15 is the only vaccine for Lyme disease in clinical development, according to GlobalData, the parent company of Pharmaceutical Technology.

Vaccine 299
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Our abysmal health care system

World of DTC Marketing

According to a 2021 study , 1.1 million deaths—including one in two of those under 65, thanks in large part to our abysmal health care system—”would have been averted if the U.S. had the mortality rates of other wealthy nations. One in three GoFundMe campaigns is now for healthcare-related costs, and it’s getting worse. The passage of the Inflation Control bill is an excellent first step in limiting high drug costs, but our healthcare system is still built for profit at the expense

Doctor 263
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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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Pathogenic Diseases Are Exacerbated by Climate Change, Scientists Warn

AuroBlog - Aurous Healthcare Clinical Trials blog

There are more than a thousand different ways that climate change can cause outbreaks of infectious disease in humans, according to a new review. When analyzing the literature on 375 human pathogens, researchers from the University of Hawai?i at M?noa and the University of Wisconsin-Madison in the US found 58 percent of these diseases were, at […].

Scientist 237
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Children's hospitals are the latest target of anti-LGBTQ harassment

NPR Health - Shots

The harassment campaigns are organized online, raising questions about what role social media platforms should play in preventing abuse.

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Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld

pharmaphorum

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. That’s the position of multiple patient organisations, clinicians and medical groups, who have criticised the Department of Health’s decision to defer procurement of Evusheld supplies until cost-effectiveness agency

Antibody 145
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Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives.

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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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No drugs for prions: could new approaches alleviate therapeutic scarcity?

Pharmaceutical Technology

The development of therapeutics for transmissible spongiform encephalopathies (TSEs) continues to be challenged by the complex nature of these diseases. Also referred to as prion diseases, TSEs are rare and fatal neurodegenerative conditions. As per the prevailing prion theory, a misfolded version of a normal cell-surface protein acts as the chief infectious agent.

Drugs 299
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Why DTC isn’t, and is, marketing

World of DTC Marketing

CPG marketers are trying to maintain market share amid price increases and smaller product sizes, leading to a more significant jump in consumerism. But, in pharma marketing, the changes affect every product category. Consumers share more information online than ever as inflation cuts into their disposable income. I’ve seen posts on everything from opinions on detergents to the best and more inexpensive ice cream.

Marketing 252
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Here’s How to Work Out Muscle Knots, According to an Exercise Physiologist

AuroBlog - Aurous Healthcare Clinical Trials blog

Imagine you’ve just completed a tough upper-body workout. Your muscles feel a bit tired, but all in all, you’re able to go about the rest of your day just fine. The next morning, you wake up and realize the back of your shoulder blade feels stiff. When you rub your shoulder muscles, it feels like […].

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Released during COVID, some people are sent back to prison with little or no warning

NPR Health - Shots

"Where is the fairness?" One mother was sent back after a single failed drug test, and her family's life has now been turned upside down for more than a year.

Drugs 145
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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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What scientists know — and don’t know — about how monkeypox spreads

STAT News

The explosive trajectory of monkeypox to nearly 90 countries since the current outbreak was detected in the United Kingdom in mid-May has caught many governments off-guard , and created confusion about how monkeypox spreads from person to person. In some ways, the virus is acting differently than it has in the past. For decades, researchers in West and Central Africa, where the virus is endemic, have observed that outbreaks there tend to be self-limiting.

Scientist 145
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How a small UK biotech ended up in Gilead’s hands

Bio Pharma Dive

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research.

Research 353
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FDA grants Fast-Track status for Relmada’s major depressive disorder therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). A new chemical entity and NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission. Presently, the therapy is being analysed in late-stage studies.

Trials 297
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Obesity: Is killing us all

World of DTC Marketing

The new Inflation Bill will not reduce healthcare costs in the U.S. Why? An analysis predicts that by 2030, 48.9% of adults in the United States will be obese, and 24.2% will be severely obese. Annual obesity-related medical care costs in the United States, in 2019 dollars, were estimated to be nearly $173 billion. Annual nationwide productivity costs of obesity-related absenteeism range between $3.38 billion and $6.38 billion.

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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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R&D funding through BIRAC declines in three years

AuroBlog - Aurous Healthcare Clinical Trials blog

The amount released by the Central government towards drug development and research and development (R&D) through the Biotechnology Industry Research Assistance Council (BIRAC) has come down by almost 50 per cent in the last two fiscal years. The disbursement declined drastically in 2020-21, during when the Covid-19 pandemic hit the country and the government allocated […].

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Kid Cudi says he had a stroke at 32. Hailey Bieber was 25. How common are they?

NPR Health - Shots

Strokes in adults under 45 are on the rise. Now artist Kid Cudi — long considered an ambassador for mental health issues — and model Hailey Bieber have opened up about their experiences.

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STAT+: Hospitals win higher payments from Medicare after lobbying campaign

STAT News

Hospitals secured significantly larger payments from Medicare for 2023, after months of lobbying centered around arguments that inflation and the pandemic have crippled hospitals’ finances. The increase to the hospital “ market basket update ” — a key metric that determines the price growth of hospital goods and services — is the largest from Medicare since 1998, the Centers for Medicare & Medicaid Services said in the final rule that came out Monday evenin

Marketing 145
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A biotech startup gives Merck its next shot at Alzheimer’s

Bio Pharma Dive

Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases.

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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