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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Tapping into pharma’s growing opportunities in digital health

Pharmaceutical Technology

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Smarter diagnostic tools and more sophisticated remote- and self-care models will have an increasingly important role to play, as long as any advances are seen to deliver excellent outcomes and a better patient experience.

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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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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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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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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
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Digital health app linked to better outcomes in heart failure

pharmaphorum

A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.

Doctors 145

More Trending

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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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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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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?

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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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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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New study use musical tests for early detection of cognitive decline

Pharma Times

Researchers at Tel Aviv University used a portable brain activity-measuring device to detect cognitive decline in older people

Research 148
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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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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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Connecting EHR to clinical trials: How to embrace the promise of real-world data

pharmaphorum

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been slow, but the industry now has everything it needs to close the feedback loop between science, evidence, and care, said speakers at a recent Co

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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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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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Pharma Distribution: Carving New Ground

Pharmaceutical Commerce

Pharmaceutical distribution today is anything but monolithic. While companies in this space are grappling with issues ranging from inflation and supply chain disruption to workforce scarcity and DSCSA implementation, there’s still plenty of room for smaller players to stake out part of the terrain to call their own.

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‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

Bio Pharma Dive

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields.

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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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Moderna signs contract to supply Covid-19 booster vaccines to the US

Pharmaceutical Technology

Moderna has entered a new supply contract with the US Government to deliver 66 million doses of its Covid-19 vaccine booster candidate, mRNA-1273.222. The contract comprises a $1.74bn award to produce and supply these vaccine doses and options to further procure up to 234 million additional doses of the company’s booster candidates. A bivalent booster candidate, the mRNA-1273.222 vaccine comprises Spikevax along with the Omicron BA.4/5 strain messenger RNA (mRNA).

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Novartis extends Kaiku digital patient monitoring partnership

pharmaphorum

Kaiku Health’s year-old alliance with Novartis to develop a digital patient monitoring and management (DPPM) system for patients with melanoma is being extended, according to the two partners. The original agreement last year focused on melanoma patients who are receiving BRAF/MEK combination therapies – specifically Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib) drugs – and has resulted in the development of a digital module tailored to their needs.

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What's behind the FDA's controversial strategy for evaluating new COVID boosters

NPR Health - Shots

Some scientists are alarmed that the agency plans to evaluate the next generation of boosters by reviewing mouse studies alone. Others say there's no time to waste waiting for human trials.

Scientist 145
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U.S. declares monkeypox outbreak a public health emergency

STAT News

The Biden administration declared the ongoing monkeypox outbreak a public health emergency on Thursday, a move that comes amid growing case counts and a groundswell of criticism over the way the administration has handled the outbreak. The declaration comes as news stories chronicle a series of missteps in the administration’s response to the outbreak, from its failure to rapidly divert vaccine stockpiled as a hedge against bioterrorism to combat spread of monkeypox to its slow decision-m

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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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MolecuLight’s CEO Anil Amlani Discusses Next Steps for Their Wound Imaging Devices

XTalks

Medical imaging device company MolecuLight is a global leader in applying fluorescence imaging to detect and localize elevated bacterial burden in wounds. Their point-of-care devices allow clinicians to safely visualize the presence and location of high bacterial loads in real time so that clinicians can direct their wound care in the best possible way.

Bacteria 111
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Moderna follows Pfizer in asking FDA to approve updated COVID shot

Bio Pharma Dive

The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign.

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Mentorship Presents Opportunities to Address Disparities in the Clinical Research Workforce

ACRP blog

As the issues surrounding clinical trial participant diversity become better understood globally, more eyes are turning to the next frontier in drug development diversity, equity, and inclusion: the clinical research workforce. In the forthcoming August 2022 issue of Clinical Researcher from ACRP, the authors of an expanded and updated study of principal investigators, nurses, and other allied health professionals focus on understanding the motivations of these professionals for joining the heal

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Merck chases Bayer/Ionis with fast track for Factor XI drug

pharmaphorum

The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.

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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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States with the toughest abortion laws have the weakest maternal supports, data shows

NPR Health - Shots

Many of the states that are moving to ban abortion tend to have less access to health care, worse maternal and infant health care outcomes and weaker social supports for children and families.

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10 key questions about monkeypox the world needs to answer

STAT News

Just over three months ago, public health authorities in the U.K., Europe, and the U.S. began to sound the alarm on the arrival of monkeypox. Since then, this long-neglected tropical disease — which until this year was mostly limited to periodic spillovers in the areas of Western and Central Africa where the virus is endemic — has gone global.

Scientist 142
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A Saga of 75 years journey of Indian Pharmaceutical Industry

Pharma Tutor

A Saga of 75 years journey of Indian Pharmaceutical Industry. Look back of growth drive for Indian pharmaceutical industry after 75 years of independence and future roadmap. admin. Sun, 08/14/2022 - 18:21. Tags. Pharmapedia. Articles.

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Atlas Venture’s Bruce Booth on testing the IPO waters and putting the ‘tech’ in biotech

Bio Pharma Dive

In a wide-ranging conversation with BioPharma Dive, Booth, a prolific builder of new biotechs, said he’s starting to see positive signs for startups considering an IPO or private financing.

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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.