October, 2020

5 questions ahead of next week's FDA meeting on coronavirus vaccines

Bio Pharma Dive

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval

Pharma still doesn’t understand transparency

World of DTC Marketing

As development towards a COVID-19 vaccine continue so do the number of people who have said they won’t get vaccinated. The only way to get people on board with a vaccination is complete transparency about the product yet both J&J and Pfizer remain silent.

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Single-Arm Trials Using Real-World Evidence for Rare Disease Product Development

Camargo

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider.

CBD helps reduce lung damage from COVID by increasing levels of protective peptide

Scienmag

Johns Hopkins Scientists Discover Possible Key to Controlling COVID-19 Immune Response

BioSpace

They believe that by inhibiting factor D, it would reduce the inflammatory reactions that make COVID-19 so deadly

Remdesivir Fails to Prevent Covid-19 Deaths in Huge Trial

NY Times

An antiviral widely used to treat hospitalized patients did not lower the mortality rate in a multinational trial

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More Trending

Get ready for HUGE healthcare changes

World of DTC Marketing

There is going to be more coverage for virtual doctors’ visits in new employee health plans along with expanded mental health benefits and access to on-site health clinics. Of course, this comes at an increased cost even though health insurers are making a lot of money.

In the News: September Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence.

Rethinking the link between cannabinoids and learning

Scienmag

Credit: Illustration by Rita Félix, PhD. Cannabinoids have a strong influence on how our brains work and how we behave. Many people are only aware of the recreational aspect of cannabinoids.

U.S. Government Inks Antibody Cocktail Deal with AstraZeneca

BioSpace

AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail

A Dose of Optimism, as the Pandemic Rages On

NY Times

The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do

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Early signs of survival benefit raise optimism around a small biotech's ALS drug

Bio Pharma Dive

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't

Projections on pharma digital ad spending wrong

World of DTC Marketing

GOOD MORNING: eMarketer is promoting a report on pharma’s projected digital ad spending in the coming year, and from my conversations with pharma insiders, it’s wrong. There will be an investment in new digital platforms but display and search spending, I believe, are going to decline.

“Get the First Inch Right”: Oncology Combination Product First-in-class Treatment Success Story

Camargo

Throughout the life-cycle of a drug development program, sponsors are confronted with a range of key questions. They must decide on the correct….

Fats fighting back against bacteria

Scienmag

Droplets of fat inside our cells are helping the body’s own defence system fight back against infection, University of Queensland researchers have discovered.

CRISPR Pioneers Doudna and Charpentier Win Nobel Prize in Chemistry

BioSpace

There is little doubt that CRISPR gene editing is and will continue to revolutionize biology and medicine. The Nobel Committee confirmed their belief in that by awarding the Nobel Prize in Chemistry to Emmanuelle Charpentier and Jennifer A. Doudna for their discovery and development of CRISPR

ERT Announces Leadership Transition

ERT

ERT, a leading global data and technology company which minimizes risk and uncertainty in clinical trials, today announced that Joe Eazor will succeed Jim Corrigan as President and Chief Executive Officer effective October 5, 2020. Jim will continue to support the company during a transition period.

Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination

Half a million-dollar bonus for cancer drug price increase

World of DTC Marketing

WHAT NOW: The idea that most pharma companies are here to serve patients is a canard. Pharma CEO’s serve themselves with big salaries tied to drug prices and keeping drugs from coming off patent.

UCB acquires new campus to support UK operations

Pharma Times

Following completion of acquisition, site will undergo refurbishment

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Zeptoseconds: new world record in short time measurement

Scienmag

Physicists from Frankfurt, Hamburg and Berlin track the propagation of light in a molecule Credit: Sven Grundmann, Goethe University Frankfurt FRANKFURT. In 1999, the Egyptian chemist Ahmed Zewail received the Nobel Prize for measuring the speed at which molecules change their shape.

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Keytruda Flexes its Muscle in Long-Term Lung Cancer Studies

BioSpace

New data presented at the IASLC 2020 North America Conference on Lung Cancer shows a combination of Keytruda with other medications has a positive impact on non-small cell lung cancer

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Clinical trials have ‘much work to do’ in boosting diversity

Outsourcing Pharma

A veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short. Clinical Development

Achieving success in pharma marketing: The need for a personalized, omnichannel approach

Bio Pharma Dive

Personalized, insight-driven omnichannel marketing has never been more beneficial or important

New cancer drug clinical trials struggling

World of DTC Marketing

WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19.

Maintaining Both Your Business and Your Sanity During the Pandemic

Pharma Marketing Network

Just a little more than seven months ago, pharma, agencies, vendors, physicians, pharmacists, patients, and medical supply chains in the U.S. and across the world were caught in a whirlwind of groundlessness and anxiety as Covid -19’s spread quickly enveloped much of the planet.

Parkinson’s disease is not one, but two diseases

Scienmag

A major study from Aarhus University in Denmark has now identified that there are actually two types of Parkinson’s disease.

Pfizer: Expanding North Carolina Gene Therapy Facility and Adding Jobs

BioSpace

Pfizer is continuing to invest in gene therapy research and development and other areas going on throughout the company, specifically in its North Carolina sites in Chapel Hill and Kit Creek

Pharmacovigilance in times of COVID-19

Cloudbyz

The COVID-19 pandemic is ravaging the world in so many ways. It has affected and hit hard how clinical trials were done and managed in pre-COVID times.

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From no drugs to 3: Patients with spinal muscular atrophy now face hard choices

Bio Pharma Dive

The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position

DTC marketers disconnect from digital marketing

World of DTC Marketing

HERE’S THE PITCH: Guidelines surrounding effective frequency are different by every advertised product. For pharma products, effective frequency is, for example, the frequency at which someone is going to go online to learn more about your product. TV alone is not going to sell your product. You need to invest in digital marketing too. DTC marketers should be joined at the hip with their market research people.

How to Set and Meet Expectations for Your Clinical Trials: Track Staff Effort

Forte Research Systems®

Learn how sites can quantify protocol complexity and anticipate resources to ensure more efficient clinical trial processes. Metrics Site Management Clinical Trial Metrics

Groundbreaking research into solar energy technology develops through new EU-project

Scienmag

Credit: Yen Strandqvist/Johan Bodell/Chalmers University of Technology Over the last few years, a specially designed molecule and an energy system with unique abilities for capturing and storing solar power have been developed by a group of researchers from Chalmers University of Technology in Sweden.

White House Reverses Course, Approves New FDA COVID-19 Vaccine Guidelines

BioSpace

The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization