Tue.Sep 01, 2020

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AstraZeneca, vowing it won't cut corners, begins large US study of coronavirus vaccine

Bio Pharma Dive

Amid reports the U.S. might fast-track AstraZeneca and the University of Oxford's experimental shot, the company pledged to "follow the science.

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Bradykinin Hypothesis of COVID-19 Offers Hope for Already-Approved Drugs

BioSpace

A group of researchers at Oak Ridge National Lab used the Summit supercomputer, the second-fastest in the world, to analyze data on more than 40,000 genes from 17,000 genetic samples related to COVID-19.

Genetics 144
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Healthcare workers likely to be first in line for coronavirus vaccination

Bio Pharma Dive

Initial vaccine supplies will be limited. Advisory groups, most recently that of the National Academies, are developing plans to figure out who should get access first.

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Sanofi/Regeneron’s Kevzara fails again in serious COVID-19 cases

pharmaphorum

Sanofi has drawn another blank in its attempt to repurpose its IL-6 drug Kevzara to tackle the extreme immune reaction seen in serious cases of COVID-19. The French pharma and development partner Regeneron have been testing Kevzara (sarilumab) in patients severely or critically ill and hospitalised with COVID-19. In severe cases of COVID-19, patients suffer a “cytokine storm” where the immune system becomes overstimulated and attacks the body.

Trials 111
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Sanofi ends research of arthritis drug as coronavirus treatment

Bio Pharma Dive

Kevzara failed to shorten hospital stays among patients severely sick with COVID-19, study results showed, further dimming hopes that drugs similar to it could help combat the disease.

Drugs 164
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At Least 4 Vaccine Candidates Backed by U.S. Government Predicated to Fail, Analytics Group Says

BioSpace

The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.

More Trending

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Intercept Pharma to Cut 170 Employees in Wake of CRL for NASH Treatment

BioSpace

In an 8-K filing with the U.S. Securities and Exchange Commission, Intercept Pharmaceuticals said it will eliminate approximately 170 employees as part of an effort to streamline the company’s operations and reduce operating expenses.

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PhIII US trial for AZ' coronavirus vaccine

Pharma Times

Clinical development of AZD1222 is progressing globally with late-stage clinical trials ongoing in the UK, Brazil and South Africa

Trials 120
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House Committee Subpoenas AbbVie Over Drug Pricing for Humira, Imbruvica

BioSpace

Shares of AbbVie fell nearly 4% Tuesday following the issuance of a subpoena from the U.S. House Oversight and Reform Committee regarding an ongoing investigation into drug pricing.

Drugs 106
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UK launch for Novo's new diabetes pill

Pharma Times

Rybelsus is the world’s first and only oral GLP-1 receptor agonist

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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CDC’s Recent Data Claim Causes Stir, Underlines Data and Societal Issues

BioSpace

Recently, the U.S. Centers for Disease Control and Prevention (CDC) made a regular data update on COVID-19 deaths. Unfortunately, the data, and how it was presented, was immediately misinterpreted.

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Rapper Master P Launches Black-Owned Replacements for Aunt Jemima And Uncle Ben’s

XTalks

Master P has launched a line of “Uncle P” food products to offer consumers a Black-owned alternative to brands that use Black names and imagery, but don’t often give back to Black communities. The New Orleans rapper and serial entrepreneur told CNN that he had always assumed brands like Aunt Jemima and Uncle Ben’s were Black-owned. It wasn’t until recently, when some brands began to be phased out for perpetuating harmful racial stereotypes, that he learned about their problematic histori

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Icelandic COVID-19 Study: Long-Lasting Antibodies and 0.3% Death Rate

BioSpace

There is new research out of Iceland that suggests the body’s immune response to COVID-19 lasts longer than other research has suggested.

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Nestlé to acquire Aimmune Therapeutics, growing food allergy portfolio

BioPharma Reporter

Swiss giant Nestlà is to acquire Aimmune Therapeutics, a biopharmaceutical company developing and commercializing treatments for food allergies. Aimmuneâs Palforzia is the worldâs first approved treatment for peanut allergy.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Maria Pazi named European Science Journalist of the Year at ECSJ2020

Scienmag

Credit: Provided by Maria Pazi Maria Pazi from Russia named European Science Journalist of the Year – 2020. The runners up are Micho Tatalovic (UK/Croatia) and Stan van Pelt (Netherlands). The announcement was made in Trieste during the closing ceremony of the European Conference of Science Journalism, ECSJ2020. The award was first launched in 2014 […].

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Kevzara fails in PhIII COVID-19 trial

Pharma Times

Sanofi and Regeneron do not anticipate carrying out further research on Kevzara in COVID-19

Trials 123
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Differing diets of bonobo groups may offer insights into how culture is created

Scienmag

New study focuses on neighboring bands of one of our closest relatives Credit: the Kokolopori Bonobo Research Project/Liran Samuni Human societies developed food preferences based on a blend of what was available and what the group decided it liked most. Those predilections were then passed along as part of the set of socially learned behaviors, […].

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COVID-19 report shares insights on potential therapies

Outsourcing Pharma

A new scientific report offers a comprehensive review of protein targets, associated COVID-19 drug candidates to date and other revealing information.

Protein 96
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Failure of ex-US Kevzara phase 3 further dents IL-6 COVID-19 hypothesis

BioPharma Reporter

Sanofiâs Kevzara fails to beat placebo in COVID-19 phase 3, further diminishing hopes of repurposing anti-IL-6 antibodies.

Antibody 105
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StageBio Looks to Expand Its Life Sciences Footprint with New Massachusetts Facility

BioSpace

A new 10,000 square foot facility in Marlborough, MA will allow StageBio to offer their expanded histopathology expertise and grow the company’s reach across the greater Boston region.

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FDA tees up pre-election deep dive into COVID-19 vaccines

BioPharma Reporter

FDA schedules COVID-19-focused vaccine advisory committee for 12 days before US presidential election.

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Project Management & Planning for Successful Clinical Trials

Forte Research Systems®

Follow these project management and planning basics while conducting clinical research at your site.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Australia tracks 35% jump in flu vaccine shipments

BioPharma Reporter

Flu vaccine shipments surge to record high in Australia against backdrop of COVID-19 pandemic.

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Celyad's High Hopes for a Path Forward in Cancer Immunotherapy with CYAD-211

BioSpace

Celyad Oncology is at the forefront of cutting-edge immunotherapy and is hopeful of providing a new way forward for patients with relapsed/refractory multiple myeloma.

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AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

pharmaphorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response. AZ already has late-stage trials ongoing in the UK, Brazil and South America, with trials planned to start in Japan and Russia, recruiting up to 50,000 patients globally.

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Scent-sensing cells have a better way to fight influenza

Scienmag

Olfactory neurons can fight and clear influenza B without being killed Credit: Sebastian Wellford, Moseman Lab, Duke University DURHAM, N.C. – Influenza researchers have long focused most of their efforts on the epithelial cells lining the lungs because these are the cells that become infected and killed while producing new copies of the virus.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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GSK, Vir Bio start study of COVID-19 antibody therapy

Pharma Times

The Phase II/III COMET-ICE study will assess safety and efficacy of antibody treatment in preventing hospitalisation due to COVID-19

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Scientists shed new light on pollen tube growth in plants

Scienmag

New findings reveal the unexpected role of an enzyme called KATANIN in guiding the growth of pollen tubes in flowering plants Credit: Lucie Riglet (CC BY 4.0) New insight on how an enzyme ensures the correct growth of pollen tubes in flowering plants has been published today in the open-access journal eLife. The study reveals […].

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Cheap Imodium alternative | Generic loperamide

Druggist

Without a doubt, Imodium is the most popular brand used as diarrhoea relief medication. Today’s post focuses on Imodium alternative drugs for the relief of diarrhoea. Causes of diarrhoea Diarrhoea is a common condition, which can affect children and adults of any age. A ‘stomach bug’ often causes acute diarrhoea, but an underlying condition and drugs can also cause it.

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Indigenous custody reporting made more effective

Scienmag

UTS and Aboriginal Legal Service to develop UX platform for greater functionality Credit: Bill Oxford on unsplash The Aboriginal Legal Service (NSW/ACT) Limited (‘ALS’) is collaborating with Rapido Social at the University of Technology Sydney (UTS) to improve its Custody Notification Service (CNS), following project funding from the National Indigenous Advancement Agency (NIAA).

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.