August, 2020

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

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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.

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?

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. The post Developing Drug Products with the Label’s Commercial Value in Mind appeared first on Camargo. Blog Commercialization

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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Machine learning reveals role of culture in shaping meanings of words

Scienmag

Credit: Thompson et al. What do we mean by the word beautiful? It depends not only on whom you ask, but in what language you ask them.

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When you many patients think of a doctor’s office, hospital, or healthcare facility, they picture a stuffy, cold, and outdated facility that increases your anxiety.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.

The sweeping biotech business model

World of DTC Marketing

R&D has been replaced with acquisitions. The latest is J&J’s deal to buy out Momenta for $6.5 billion. This week alone Sanofi, BMS, and other big pharma companies have spent billions on the purchase of smaller, promising companies who have drugs that could lead to happy investors.

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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. 505(b)(2) Development Blog DESI Drug Regulatory Strategy & Submissions

Community Outbreak Investigation of SARS-CoV-2 Transmission Among Bus Riders in Eastern China

JAMA Internal Medicine

This cohort study examines the potential for airborne spread of COVID-19 through investigation of an outbreak among bus riders in Eastern China

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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

12 facts you must know – FLU SEASON 2020/2021

Druggist

With just one month to go, flu season 2020/2021 is just around the corner. It is expected to be that demand for flu vaccination service will be high this year. NHS England has an ambitious target for the uptake in eligible patients groups of at least 75%.

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

Pharma is hiring

World of DTC Marketing

IN BRIEF: Pharma companies have been posting jobs on LinkedIn almost every day. While most offices remain closed pharma is preparing for the launch of new products and has to have the infrastructure to ensure a successful launch.

The age of the Earth’s inner core revised

Scienmag

Credit: NASA/ Gary A.Glatzmaier By creating conditions akin to the center of the Earth inside a laboratory chamber, researchers have improved the estimate of the age of our planet’s solid inner core, putting it at 1 billion to 1.3 billion years old.

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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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

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. Clinical Development

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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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Medscape on shift to digital

World of DTC Marketing

COVID-19 has disrupted traditional healthcare person-to-person communication and accelerated digital options, such as telehealth and remote patient-clinician contacts, digital therapeutics that deliver remote patient monitoring, and interventions through the use of software.

Electric cooker an easy, efficient way to sanitize N95 masks, study finds

Scienmag

Credit: Photo by Chamteut Oh CHAMPAIGN, Ill. — Owners of electric multicookers may be able to add another use to its list of functions, a new study suggests: sanitization of N95 respirator masks.

New Breast Cancer Drug Shows Promise in Halting Disease Progression

BioSpace

According to data from Phase I clinical trials, a new breast cancer drug developed by researchers at the University of Illinois Chicago can potentially stop disease progression without toxicity

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

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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

Medical Marijuana: Is it a blessing in disguise or a curse for humanity?

Delveinsight

The influx of companies, the launch of pipeline therapies, and the legalization of marijuana/ cannabis are the major drivers of the medical marijuana market. Cannabis, popularly known as Marijuana, is the most commonly used illicit drug after alcohol.

Sorry.COVID treatment data may not be reliable

World of DTC Marketing

IN SUMMARY: “For the first time ever, I feel like official people in communications and people at the F.D.A. grossly misrepresented data about a therapy,” said Dr. Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

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Cashew shell compound appears to mend damaged nerves

Scienmag

Credit: Vanderbilt University Medical Center In laboratory experiments, a chemical compound found in the shell of the cashew nut promotes the repair of myelin, a team from Vanderbilt University Medical Center reports today in the Proceedings of the National Academy of Sciences.

Merck to Build $1.3 Billion Research Hub in London

BioSpace

The new research hub will be called the London Discovery Research Centre and is expected to open by 2025

Bristol Myers pledges to spend $300M on addressing racial, health disparities

Bio Pharma Dive

The drugmaker aims to double Black and Latinx representation in its executive ranks, among other commitments

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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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Researchers says hydroxychloroquine could still prevent COVID-19

Pharma Times

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

The hypocrisy of pharma trade magazines

World of DTC Marketing

QUICK READ: Our industry is inundated with trade magazine pseudo awards that don’t mean a damn thing to the patients we serve. The dirty secret is that these trade magazines use these awards as a business tactic to draw in more readers and ad dollars.

Metallic blue fruits use fat to produce color and signal a treat for birds

Scienmag

Credit: Rox Middleton Researchers have found that a common plant owes the dazzling blue colour of its fruit to fat in its cellular structure, the first time this type of colour production has been observed in nature.