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 337
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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.

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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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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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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.’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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More Trending

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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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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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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.

Doctors 295
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GSK bags EU approval for Blenrep

Pharma Times

Blenrep is a first-line inhibitor of BCMA, a cell-surface protein that plays a crucial role in the survival of plasma cells and is expressed on multiple myeloma cells

Protein 130
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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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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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Moderna says its coronavirus vaccine sparks immune response in older people

Bio Pharma Dive

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

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Pharma improves HCP engagement during COVID-19 – report

pharmaphorum

Pharma companies have improved how they engage with healthcare providers as a result of COVID-19, according to a new survey of HCPs. This has resulted in pharma companies being more relevant and providing more value in closing the care gap, the report says. The Accenture survey of 720 general practitioners, oncologists, cardiologists and immunologists globally found that this is in turn helping HCPs better serve patients.

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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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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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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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Researchers says hydroxychloroquine could still prevent COVID-19

Pharma Times

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

Research 168
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Two P.R. Experts at F.D.A. Have Been Ousted After Blood Plasma Fiasco

NY Times

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

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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.

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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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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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FDA’s Hahn Apologizes for Overstating Benefit of COVID-19 Plasma Treatment

BioSpace

“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.

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Moderna makes commercial case for COVID-19 vaccine amid price pressure

BioPharma Reporter

Moderna Therapeutics reveals it is selling its COVID-19 vaccine for up to $37 a dose, well above the amount charged by some of its rivals.

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AbbVie submits Rinvoq for ankylosing spondylitis

Pharma Times

In a pivotal Phase II/III study, twice as many patients receiving the drug achieved the primary endpoint of ASAS 40 response at week 14 versus placebo

Drugs 128
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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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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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Editas, AbbVie rework gene editing deal as pioneering CRISPR trial resumes

Bio Pharma Dive

Development of EDIT-101, the first CRISPR-based therapy to be used in a company-led trial to alter genes within a person's body, will now move forward under Editas' sole ownership.

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Finding resilience after an HIV diagnosis

pharmaphorum

Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. He tells pharmaphorum about the importance of resilience in coping with a serious illness. John first began writing about HIV/AIDS as a journalist in 1986. “I had two friends of mine in their 20s die from AIDS while I was in journalism school in 1985 – a time when AIDS was always in the news and there was a lot

Doctors 128
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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 143
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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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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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Combining the Powers of Single Cell Sequencing and AI in Understanding Disease Biology and Drug Development

XTalks

Single cell sequencing has revolutionized the study of biological tissues and systems at the cellular and molecular level. Recent advances in the technology have allowed for the interrogation of distinct subsets of cell populations within tissues, and associated molecular markers that may function as important disease drivers. The use of single cell sequencing in profiling bulk, heterogeneous tissues at the single cell level can help in the identification of dominant, unique and rare cell subtyp

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Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

NY Times

A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials.

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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.

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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.