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Category: biotech/medical – Page 1648

Moderna, Inc.’s COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID).

Moderna said its closely-watched COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The Phase III “COVE” study (NCT04470427) is expected to begin registration at study centers nationwide beginning on July 21 with study initiation set for six days later. The primary endpoint of the randomized, 1:1 placebo-controlled trial will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease as defined by the need for hospitalization, and prevention of infection by SARS-CoV-2, Moderna said.

Moderna disclosed plans for the Phase III trial on Clinicaltrials.gov the same day that researchers from NIAID, Moderna, and their clinical research partners reported that mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2, in an interim analysis of results from their Phase I study (NCT04283461).

Continue reading “Moderna Advancing COVID-19 Vaccine into Phase III after Positive Initial Clinical Results” | >

Scientists from Trinity College Dublin have discovered a new link between impaired brain energy metabolism and delirium—a disorienting and distressing disorder particularly common in the elderly and one that is currently occurring in a large proportion of patients hospitalized with COVID-19 [15th of July 2020].

While much of the research was conducted in mice, additional work suggests overlapping mechanisms are at play in humans because cerebrospinal fluid (CSF) collected from patients suffering from delirium also contained tell-tale markers of altered brain glucose .

Collectively, the research, which has just been published in the Journal of Neuroscience, suggests that therapies focusing on brain energy metabolism may offer new routes to mitigating delirium.

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No industry will be spared.

The pharmaceutical business is perhaps the only industry on the planet, where to get the product from idea to market the company needs to spend about a decade, several billion dollars, and there is about 90% chance of failure. It is very different from the IT business, where only the paranoid survive but a business where executives need to plan decades ahead and execute. So when the revolution in artificial intelligence fueled by credible advances in deep learning hit in 2013–2014, the pharmaceutical industry executives got interested but did not immediately jump on the bandwagon. Many pharmaceutical companies started investing heavily in internal data science R&D but without a coordinated strategy it looked more like re-branding exercise with the many heads of data science, digital, and AI in one organization and often in one department. And while some of the pharmaceutical companies invested in AI startups no sizable acquisitions were made to date. Most discussions with AI startups started with “show me a clinical asset in Phase III where you identified a target and generated a molecule using AI?” or “how are you different from a myriad of other AI startups?” often coming from the newly-minted heads of data science strategy who, in theory, need to know the market.

However, some of the pharmaceutical companies managed to demonstrate very impressive results in the individual segments of drug discovery and development. For example, around 2018 AstraZeneca started publishing in generative chemistry and by 2019 published several impressive papers that were noticed by the community. Several other pharmaceutical companies demonstrated impressive internal modules and Eli Lilly built an impressive AI-powered robotics lab in cooperation with a startup.

However, it was not possible to get a comprehensive overview and comparison of the major pharmaceutical companies that claimed to be doing AI research and utilizing big data in preclinical and clinical development until now. On June 15th, one article titled “The upside of being a digital pharma player” got accepted and quietly went online in a reputable peer-reviewed industry journal Drug Discovery Today. I got notified about the article by Google Scholar because it referenced several of our papers. I was about to discard the article as just another industry perspective but then I looked at the author list and saw a group of heavy-hitting academics, industry executives, and consultants: Alexander Schuhmacher from Reutlingen University, Alexander Gatto from Sony, Markus Hinder from Novartis, Michael Kuss from PricewaterhouseCoopers, and Oliver Gassmann from University of St. Gallen.

Continue reading “Deep Dive Into Big Pharma AI Productivity: One Study Shaking The Pharmaceutical Industry” | >

For the first time, scientists have determined the complete sequence of a human chromosome, namely the X chromosome, from ‘telomere to telomere’. This is truly a complete sequencing of a human chromosome, with no gaps in the base pair read and at an unprecedented level of accuracy.

A step closer towards the complete blueprint of a human being

The Human Genome Project was a 13-year-long, publicly funded project initiated in 1990 with the objective of determining the DNA sequence of the entire human genome.

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Japanese researchers have created a smart face mask that has a built in speaker and can translate speech into 8 different languages.

We live in a world full of technology but it was a world without smart masks, until now!

A Japanese technology company Donut Robotics has taken the initiative to create the first smart face masks which connects to your phone. Of course, we couldn’t have battled coronavirus with a simple mask that still does the job of protecting us perfectly well. We as a race need to bring technology into everything and more so if it does an array of extremely important, life-saving things like using a speaker to amplify a person’s voice, covert a person’s speech into text and then translate it into eight different languages through a smartphone app.

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Under certain circumstances in patients, the human immune system can spin out of control and become highly toxic, resulting in cytokine release syndrome (CRS). CRS has been observed in certain autoimmune diseases (Grom et al. 2016), during highly infectious diseases like COVID-19 (Zhang et al. 2020), and following immune-enhancing treatments that include monoclonal or bispecific antibodies, or CAR T therapies (Shimabukuro-Vornhagen et al. 2018). CRS, which can be deadly, has been notoriously difficult to study and for which to develop novel treatments. However, encouraging new data indicates that many aspects of human CRS can be modeled in immunodeficient NSG mice engrafted with human peripheral blood mononuclear cells (PBMCs). This model provides hope that new immuno-modulatory therapies can be safely developed and tested before clinical trials.

Figure 1. TGN1412 analogue (anti-CD28 superagonist) mediated CRS dose response. Human PBMC engrafted NSG™-SGM3 recipient mice (stock# 013062) were treated with anti-CD28 mAb positive control or TGN1412 analogue at low, medium or high dosing. Human IFN- ɣ, TNF-α, and IL-6 were measured quantitatively at 1, 2, 4, and 6 hours post treatment. Increasing doses of TGN1412 analogue showed a progressively increased cytokine release response.

The next question was whether PBMC donor-specific differences in drug response could be observed, mimicking what is observed clinically. Cohorts of mice were engrafted with nine different human PBMC donors, and each donor cohort was tested with PBS, OKT3, or anti-CD28. In mice treated with OKT3, 7 out of 9 donors displayed a severe IFN-ɣ CRS response, 5 showed a severe IL-6 response and all exhibited a strong TNF-α response (figure 2). Donors G and H showed a milder response. When treated with anti-CD28, 2 out of 9 donors showed a severe IFN-ɣ response. Collectively, the data described in the experiments above demonstrate that specific mAbs are capable of initiating a CRS response in this model and that the response is both dose and PBMC donor dependent.

Figure 2. Human PBMC donor specific differences in magnitude of CRS response. Human PBMC from 9 different donors (A-J) were engrafted into NSG recipient mice (stock# 005557) and treated with Muromonab (OKT3, anti-CD3 mAb) or anti-CD28 mAb. Human IFN- ɣ, TNF-α, and IL-6 were measured quantitatively 6 hours post treatment. Each donor shows a quantitative difference in cytokine response to each drug tested.

Continue reading “Battling COVID-19; A New Model of Cytokine Release Syndrome” | >

British Health Minister Matt Hancock said that the government would not recommend that office workers wear face masks while at work.

“We will not be recommending masks in the office,” Hancock told Sky News on Wednesday.

Nearly a dozen Indian states have imposed a partial lockdown in high-risk areas after spikes in coronavirus cases, with the country’s infections topping 900,000 just three days after crossing the 800,000 mark.

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Bio-Wall forms a temporary flexible film over the mucosa of the nose, throat and oral cavity. Antiviral components in the bio-adhesive matrix are meant to trap the virus and block it.

“Once Bio-Wall is sprayed over the mucosa, it masks the tissue from pathogen penetration and infectious disease such as the Covid-19 virus” for several hours, says BioChange Chairman and CEO Ishay Attar.

A nasal spray in development and a surface-disinfecting spray already on the market are intended to keep us safe from virus particles in the air.

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