October, 2020

Sarepta, continuing its gene therapy push, helps launch a startup

Bio Pharma Dive

The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million

Leaders must make their organizations and the world better

World of DTC Marketing

SUMMARY: Leaders have a duty to make their companies stronger and help make the world a better place. Leadership is crucial in providing a unified vision. Pharma CEO’s shouldn’t believe that their products, alone, will help make the world a stronger place. People want and need more.

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Cause of Alzheimer’s disease traced to mutation in common enzyme

Scienmag

Mutation to MARK4 makes proteins stickier and more likely to clump in brain Credit: Tokyo Metropolitan University Tokyo, Japan – Researchers from Tokyo Metropolitan University have discovered a new mechanism by which clumps of tau protein are created in the brain, killing brain cells and causing Alzheimer’s disease.

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.

Time to Reassess Tocilizumab’s Role in COVID-19 Pneumonia

JAMA Internal Medicine

In this issue of JAMA Internal Medicine, 3 important articles explore the use of tocilizumab in coronavirus disease 2019 (COVID-19) pneumonia. Tocilizumab is a humanized monoclonal antibody that binds human interleukin 6 (IL-6) receptors.

Study Suggests COVID-19 Infection Could Age the Brain, Reduce Cognition

BioSpace

The report showed that in some cases, people who have recovered from the virus continued to exhibit significant cognitive deficits

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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

More Trending

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

Scienmag

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.

Early Treatment With Tocilizumab and Mortality Among Critically Ill Patients With COVID-19

JAMA Internal Medicine

This cohort study assesses mortality rates among patients with COVID-19 admitted to intensive care who were treated with tocilizumab

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Singapore Halts Dosing of Two Flu Shots After 59 Deaths in South Korea

BioSpace

South Korea, on the other hand, indicated they would continue their state-run vaccination program because they did not find a direct link between the deaths and the vaccinations

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness

Pharma managers too far removed from patients

World of DTC Marketing

As people move up the pharma ladder, their work often revolves around internal management issues, training, and endless meetings to motivate their employees rather than focus on patients. Pharma likes to believe its own propaganda that everything they do is patient-focused, but that’s a canard.

What cold lizards in Miami can tell us about climate change resilience

Scienmag

Credit: Photo courtesy Day’s Edge Productions It was raining iguanas on a sunny morning. Biologist James Stroud’s phone started buzzing early on Jan.

“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….

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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IBM and Pfizer Believe Machine Learning Can Predict Alzheimer’s Risk

BioSpace

Researchers with Pfizer and IBM developed an artificial intelligence (AI) model that they claim can predict eventual onset of Alzheimer’s disease with 71% accuracy based on a language sample. They published the research today in The Lancet eClinicalMedicine

Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Bio Pharma Dive

Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs

Web analytics should tell a story

World of DTC Marketing

IN SUMMARY: Web analytics really has nothing to do with numbers. They have everything to do with what the numbers are telling you about your audience and messaging. DTC marketers need to get out of the mindset of using raw numbers and ask their web analytics people for insights instead.

Giving the immune system a double boost against cancer

Scienmag

Credit: CSHL, 2020 Cancer immunotherapies, which empower patients’ immune systems to eliminate tumors, are revolutionizing cancer treatment. Many patients respond well to these treatments, sometimes experiencing long-lasting remissions.

Anatomy of a Nonclinical Study Monitoring Report

Camargo

Perhaps surprisingly, the majority of nonclinical Contract Research Organisations (CROs) are not in glamorous locations. Not too many facilities are located near a beach or with beautiful mountain views, so arriving at their front door at 7:30 am on a cold and snowy Montreal morning in February isn’t on the bucket list of too many people.

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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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

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

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.

Research to bring more secure software for autonomous battlefield operations

Scienmag

Credit: U.S. Army Operational Test Command photo/Tad Browning WEST LAFAYETTE, Ind. — Drones and other unmanned machines can save human lives on the battlefield, but adversaries could hack into their artificial intelligence software.

Just around the corner: delivery of Syntegon’s model MWFI membrane-based “cold” WFI generation system!

Syntegon Technology Pharma Blog

Liquid Dosage Pharma Cold WFI GMP MWFI Pure Media Systems Purified Water Standardization Water for Injection Water Purification WFI WFI Production

WHO: remdesivir shows little effect on COVID-19

Outsourcing Pharma

The agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality. Clinical Development

Trials 111

COVID-19 by the Numbers: Mortality Rates in U.S. Decrease, Despite Uptick in Cases

BioSpace

The number of excess deaths in the United States is trending downward despite autumn upticks in COVID-19 incidents

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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

Unfair balance

World of DTC Marketing

WHAT’S UP? : It’s time to admit that the FDA is completely out of touch regarding DTC advertising. Fair balance is not being read in ads or listened to on TV, and the language used in fair balance is too often complicated for online health seekers.

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.

Hot WFI storage and distribution is now a standard option

Syntegon Technology Pharma Blog

Liquid Dosage Pharma Cold WFI GMP MWFI Ozonization Pure Media Systems Purified Water Standardization Water for Injection Water Purification WFI WFI Production

UK trials digital ‘health passport’ to help borders reopen

Pharma Phorum

Regular fliers are used to long queues to clear security – but a rigorous COVID-19 testing regime could be added to pre-flight checks backed by a digital “health passport” to prove passengers are free from the coronavirus.

Clinical Trial Software Company Hit by Massive Ransomware Attack

BioSpace

Philadelphia-based software company eResearchTechnology (ERT), which offers software used in hundreds of clinical trials, has suffered a ransomware attack

Record numbers of biotechs are going public. Here's how they're performing.

Bio Pharma Dive

Initial public offerings have fueled biotech's boom. A new database built by BioPharma Dive will help you keep track of them as they happen

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10 Trends for online health seekers

World of DTC Marketing

IN SUMMARY: Online health seekers are using the Internet differently since the pandemic. Treatment options are researched more, and people are using, but not relying, on social media to gather information on what’s best for THEM.