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Saliva Test for COVID-19 reduces health care professional risk of infection

April 15th, 2020 | Industry News

Saliva Test for COVID-19 Approved for Emergency Use by FDA on 13 April 2020. Saliva testing will help with the global shortage of swabs, increase possibility of people testing, and reduce risk to collect samples by health care professionals. The saliva-based test requires saliva collection by subject spitting several times in a given plastic tube. […]

COVID19 Infects the Nervous System

March 27th, 2020 | Industry News

The fact that COVID-19 patients have lost their sense of smell or taste is interesting because, if the virus infects the nose, it would use the exact same neurons as in the mouse studies to enter the brain. SARS‐CoV2 causes epidemic pneumonia characterized by acute respiratory distress. This novel coronavirus is similar to SARS‐CoV in […]

Clinical Trial of COVID-19 Vaccine Begins

March 18th, 2020 | Industry News

The first participant in a clinical safety trial for a COVID-19 vaccine conducted by the Kaiser Permanente Washington Health Research Institute in Seattle was given an experimental dose on March 16, reports the Associated Press. Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna INC. Inovio […]

How soon can a vaccine can be tested in Clinical trials? #clinicaltrials

March 13th, 2020 | Industry News

How do viral genomes’ sequences from swabs taken from infected patients help you build a family tree of the virus? Random mutations in the SARS-CoV-2 pathogen’s genome help researchers track the spread and transmission of COVID-19, the disease it causes. Source: News & Opinion Articles | The Scientist Magazine®

Clinical plan to test reconstitution of a normal gut microbiome in atopic dermatitis

February 20th, 2020 | Industry News

Over the past 50 years, the frequency of allergies and autoimmune diseases has risen rapidly. Unfortunately, there hasn’t been much progress in understanding this epidemic of allergic disease. Hay fever and atopic dermatitis have both increased more than two-fold in the past 50 years. The easy hypothesis would be to attribute this increasing incidence to […]

Innovative Approach to Clinical Plan: Virtual Trial Design.

February 18th, 2020 | Industry News

Health app designed to engage users through increased healthful living styles are at the base of this innovation in clinical plan and trial design. The design of the Health app was a collaborative effort between Janssen Pharmaceuticals and Apple Watch. The randomized trial is designed to determine if wearable technology can detect atrial fibrillation (AFib). […]

Head off the 2019-nCoV pandemic: Clinical plan for a possible therapy.

January 29th, 2020 | Industry News

We’ve had a few events where they’ve jumped from animals into people. There’s a lot being done on how coronaviruses infect people from animals. We know the real key is to know what the host cell receptor is—that’s the protein on the surface of cells that viruses bind to and invade. For SARS coronavirus, the […]

PKAN drug fails Phase III trial: How to avoid a similar disaster.

November 26th, 2019 | Industry News

Retrophin’s experimental PKAN drug fosmetpantotenate fails phase III trial Pantothenate kinase-associated neurodegeneration (PKAN) is a rare disease characterized by a progressive neurodegenerative disorder and buildup of iron in the brain which is estimated to affect up to 5000 patients worldwide. PKAN is inherited in an autosomal recessive manner and is caused by mutations in the […]

Generic EpiPen to reduce costs

November 7th, 2019 | Industry News

Teva received approval to market generic versions of Mylan’s epinephrine auto-injector for emergency treatment of allergic reactions for both adults and children in August 2018 after several years of delays in getting the generics approved. Teva Pharmaceutical EpiPen Jr. (epinephrine) auto-injector 0.15mg is market at a wholesale cost of $300 per two-pack. This is the first generic […]

The FDA Innovation Office

September 19th, 2019 | Industry News

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