August, 2020

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Lilly to test COVID-19 antibody drug in unorthodox nursing home study

Bio Pharma Dive

Seeking fast answers in a pandemic, Lilly will use mobile RVs to set up infusion clinics at assisted living facilities, which have become COVID-19 hot spots.

Nurses 341
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Biotech Startup Codagenix Plans Human Trials for COVID-19 Vaccine

BioSpace

The 11-person team at Codagenix may be tiny, but it has big plans for the company’s new COVID-19 vaccine.

Vaccine 134
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How COVID-19 is Changing FDA Approval and Clearance Processes

BioSpace

The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA Approval & Clearance.

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How pharma digital marketing can excel

World of DTC Marketing

Pharma digital marketing has been lagging behind key trends for a long while. Let’s face it, pharma organizations are not made for speed while digital marketing is all about “now” Digital marketing is also about experimentation and learning from successes as well as failures. An internal team of consultants, dedicated to digital, can add a lot of value to a company.

Marketing 302
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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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5 Ways That Digital Signage Improves a Doctor’s Office

Pharma Mirror

When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety. Offices with old decor prevent patients from visiting the doctor regularly and feeling relaxed. But what if there was a way to modernize the office affordably to make it more. The post 5 Ways That Digital Signage Improves a Doctor’s Office appeared first on Pharma Mirror Magazine.

Doctor 246
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Developing Drug Products with the Label’s Commercial Value in Mind

Camargo

Whether you plan to out-license or commercialize your product, getting the label right matters. When. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo.

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First trial participant gets GSK's 5-in-1 meningitis jab

Pharma Times

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo

Trials 177
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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

NY Times

Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.

Scientist 145
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COVID-19 and obesity is a lethal mix

World of DTC Marketing

QUICK READ : Obesity is associated with a higher risk of developing severe symptoms and complications of coronavirus disease, independent of other illnesses, such as cardiovascular disease. So why haven’t we acted? Data seems to suggest that people with obesity are more likely to become severely ill due to COVID-19, the disease caused by the novel coronavirus.

Doctor 295
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American Gene Technologies Gets Go-Ahead to Test Possible HIV Cure

BioSpace

American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

Gene 145
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Clinical Course and Molecular Viral Shedding Among Patients With SARS-CoV-2 Infection

JAMA Internal Medicine

This cohort study quantitatively describes molecular viral shedding in asymptomatic and symptomatic patients with SARS-CoV-2 infection.

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A cure for hemophilia is closer than ever. For many patients, it could be just out of reach.

Bio Pharma Dive

Approval of BioMarin's Roctavian, should it come as expected this week, would deliver on decades of unfulfilled hopes for a gene therapy fix to one of the earliest identified inherited diseases.

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Researchers says hydroxychloroquine could still prevent COVID-19

Pharma Times

Scientists from the University of Oxford say the drug is being ‘discarded prematurely’

Scientist 170
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Potential HIV cure Phase I trial gets FDA green light

Outsourcing Pharma

American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.

Trials 145
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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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The erosion of trust in health information?

World of DTC Marketing

QUICK READ: The belief that the development of a vaccine for coronavirus is being dangerously rushed, in part to improve Donald Trump’s prospects ahead of the presidential election in November are very real. In addition, Avaaz discovered that”global health misinformation spreading networks” had generated roughly 3.8 billion views for their content on Facebook.

Vaccine 249
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In the News: July Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo.

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F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold

NY Times

Government health leaders including Dr. Francis S. Collins and Dr. Anthony S. Fauci urged caution last week, citing weak data from the country’s largest plasma study.

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CanSino, Canada abandon plans for a coronavirus vaccine trial

Bio Pharma Dive

Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.

Vaccine 361
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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 accepts application for self-administered Xolair use

Pharma Times

If approved drug would offer a more flexible option for patients

Drugs 156
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NIH Awards EcoHealth Alliance $7.5 Million Grant Despite Political Furor

BioSpace

EcoHealth had already developed a partnership with a WIV laboratory in Wuhan, China, under a five-year NIH grant. It was expected to run through 2024 but was canceled in April.

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Americans continue to neglect their health

World of DTC Marketing

As the NY Times recently reported , obesity is the leading cause of mortality in the United States. Obesity costs the nation $1.72 trillion every year. In the United States, where at least 4.6 million people have been infected and over 165,000 have died, the promise of a vaccine is hampered by a vexing epidemic that long preceded Covid-19: obesity.

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Gates Foundation gives Dynavax COVID-19 grant to scale up adjuvant production

BioPharma Reporter

Dynavax gets Bill & Melinda Gates Foundation funding to scale up production of adjuvant for use in COVID-19 vaccines.

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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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Sophia Genetics launches AI tool to find COVID-19 ‘unknowns’

pharmaphorum

Swiss medical data specialist Sophia Genetics has launched a platform that will sift through data generated at more than 1,000 hospitals around the world to try to work out how the COVID-19 pandemic will evolve in the coming months and years. The data mining tool will be used to try to unearth some of the many unknowns with the virus, using next-generation sequencing (NGS) to see how the genome of SARS-CoV-2 changes over time, along with patient genetic information, results of lung and CT scans,

Genetics 136
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First oral drug for spinal muscular atrophy approved by FDA

Bio Pharma Dive

Approval of Evrysdi, from Roche and PTC Therapeutics, adds a third option for treating the neuromuscular disease, joining Spinraza and Zolgensma.

Drugs 353
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UK increases COVID-19 vaccine manufacturing capacity

Pharma Times

New deal with Wockhardt boosts capacity at the crucial 'fill and finish' stage

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Top 12 Biotech Companies Hiring Now

BioSpace

According to BioSpace research, 69% of biotech professionals feel they are on the verge of job burnout. Do you fall into that 69%? Is it time for a new job? Check out the top companies who are looking for candidates like you right now!

Research 142
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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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No digitization with HCP’s is not permanent

World of DTC Marketing

IN SUMMARY : When patients return to doctor’s offices will HCP’s have time to go online with every drug company that requests an online detail? Will patients be happy with telehealth once they feel it’s safe to return to physicians’ offices? After I read the Medscape report on the move to digitization I decided to reach out to some industry contacts to hear what they had to say.

Doctor 237
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What Is the Difference Between Oxygen Generators and CPAP?

Pharma Mirror

A CPAP machine is a device that can replace or improve human breathing, increase lung ventilation, and improve respiratory function. It is generally used for lung failure or airway obstruction to breathing normally to help the patient complete the breathing process of inhalation and exhalation. It has a variety of breathing modes (various ways in. The post What Is the Difference Between Oxygen Generators and CPAP?

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Pilot study backs Kaia Health app for back pain relief

pharmaphorum

An app developed by Kaia Health to help people suffering from back pain who may not want to take painkillers has shown its worth again in a study conducted with a health benefit plan in the US. The pilot study of the app – which combines physical therapy, relaxation exercises and medical information to help back pain sufferers manage their condition – showed it was able to reduce self-reported pain and sleep quality.

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With first results, Novavax takes step forward in coronavirus vaccine race

Bio Pharma Dive

Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.

Vaccine 352
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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