Sun.Oct 11, 2020

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U.S. Government Inks Antibody Cocktail Deal with AstraZeneca

BioSpace

AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail.

Antibody 127
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For when the chips are down — preserving UK soil microbial biodiversity for agriculture

Scienmag

New UK Crop Microbiome Cryobank to safeguard future research and facilitate sustainable production of UK’s six major food crops Credit: Pixabay Scientists from the UK’s foremost agricultural research institutes have teamed up to create a new UK Crop Microbiome Cyrobank (UK-CMCB) to safeguard future research and facilitate the sustainable yield improvement of the UK’s six […].

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Operation Warp Speed Boss Projects COVID-19 Vaccine EUA by Thanksgiving

BioSpace

Moncef Slaoui, the head of Operation Warp Speed, suggested the first Emergency Use Authorization for a COVID-19 vaccine will likely be around Thanksgiving.

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KIST addressing algal bloom in conventional water treatment facilities

Scienmag

Development of fabricating technology for high-efficiency powdered activated carbon with a fast adsorption rate. Can ensure safety against algal blooms even in conventional water treatment processes Credit: Korea Institue of Science and Technology(KIST) An algal bloom refers to a phenomenon in which phytoplankton including blue-green algae rapidly proliferate in summer marked by high levels of […].

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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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Washington Man Faces 28 Years in Prison for Fraudulent Drug Trial Scandal

BioSpace

A 41-year-old man from Richland, Wash. was convicted on 47 counts of fraud and drug related charges on Oct. 1, according to the U.S. Justice Department’s Eastern District of Washington.

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Could BCG vaccine protect against COVID-19? UK recruitment begins

Scienmag

A largescale global trial designed to test the theory that the widely-used BCG vaccine could help protect against COVID-19 will soon recruit healthcare staff and care home workers in the UK. The University of Exeter is leading the UK arm of the trial, called the ‘BCG vaccination to Reduce the impact of COVID-19 in healthcare […].

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Oncotarget: The role of miRNA-133b and its target gene SIRT1 in FAP-derived desmoid tumor

Scienmag

Volume 11, Issue 26 of Oncotarget reported that in this study the authors studied the differences in mi RNA expression between sporadic and FAP-associated Desmoid tumors using microarray confirmed by quantitative PCR. Credit: Correspondence to – Maria Teresa Rotelli – mariateresa.rotelli@uniba.it Volume 11, Issue 26 of Oncotarget reported that in this study the authors studied […].

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Innovent and Eli Lilly Gain Approval to Market Halpryza® in China

BioSpace

Innovent and Lilly expect Halpryza to be a high quality and slightly more affordable rituximab injection for a market experiencing serious needs.

Marketing 114
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Mortality in Randomized Clinical Trials Comparing PCI With CABG

JAMA Internal Medicine

This meta-analysis evaluates the difference in all-cause and cause-specific mortality in randomized clinical trials comparing percutaneous coronary intervention with coronary artery bypass grafting for the treatment of patients with coronary artery disease.

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More Manufacturing, More Jobs - Abzena drops $60 Million on New San Diego Facility

BioSpace

New 50,000-square-foot facility will allow them to expand their services from development and Phase I/II to Phase III and manufacturing.

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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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Engineers print wearable sensors directly on skin without heat

Scienmag

An international team of researchers developed a novel technique to produce precise, high-performing biometric sensors Credit: Ling Zhang, Penn State/Cheng Lab and Harbin Institute of Technology Wearable sensors are evolving from watches and electrodes to bendable devices that provide far more precise biometric measurements and comfort for users. Now, an international team of researchers has […].

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What We Now Know About Coronavirus Transmission: Where the Virus Goes in your Body and How it is.

BioSpace

It is important to remember that this is a new virus, so researchers are constantly learning more about it every day.

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COVID-related delays to CRC screening causing 11.9% rise in death rates, research reveals

Scienmag

Based on survival rates at 5 years for stage III-IV CRC, the results showed a significant 11.9% increase in deaths when comparing a 0-3 month delay to a >12 month delay Credit: UEG (Vienna, October 12, 2020) New research presented today at UEG Week Virtual 2020 has shown that delays in colorectal cancer (CRC) screening […].

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Several Researchers Raise Concerns About Russian Vaccine Data

BioSpace

In early August, Russia became the first country to approve a coronavirus vaccine.

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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.

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Cnew research on SARS-CoV-2 virus ‘survivability’

Scienmag

Credit: CSIRO Researchers at CSIRO, Australia’s national science agency, have found that SARS-CoV-2, the virus responsible for COVID-19, can survive for up to 28 days on common surfaces including banknotes, glass – such as that found on mobile phone screens – and stainless steel. The research, undertaken at the Australian Centre for Disease Preparedness (ACDP) […].

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Clinical Catch-Up: October 5-9

BioSpace

It was a moderately busy week for clinical trial news. Here’s a look.

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Central Asian horse riders played ball games 3,000 years ago

Scienmag

Credit: (Picture: UZH) Today, ball games are one of the most popular leisure activities in the world, an important form of mass entertainment and big business. But who invented balls, where and when? The oldest balls that are currently known about were made in Egypt about 4,500 years ago using linen. Central Americans have been […].

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Alkermes' Schizophrenia Drug Passes FDA Advisory Committee Hurdle

BioSpace

Shares of Alkermes were up more than 12% in pre-market trading after the Ireland-based company announced late Friday that its schizophrenia drug was overwhelmingly supported by an advisory committee for the U.S. Food and Drug Administration.

Drugs 72
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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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In the eye of a stellar cyclone

Scienmag

Sydney undergraduate unlocks bizarre secrets of a ticking time-bomb star Credit: European Southern Observatory While on COVID lockdown, a University of Sydney honours student has written a research paper on a star system dubbed one of the “exotic peacocks of the stellar world” Only one in a hundred million stars makes the cut to be […].

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Ibrance trial failure dashes Pfizer’s growth hopes for the drug

pharmaphorum

Pfizer already makes big revenues from its breast cancer drug Ibrance, but a late-stage trial failure has set back its hopes of even loftier sales – and set up a challenge from Eli Lilly’s rival drug Verzenio. The phase 3 PENELOPE-B trial was testing the CDK4/6 inhibitor as a potential treatment for early breast cancer patients who have residual invasive disease following neoadjuvant (pre-surgery) chemotherapy, but failed to show an improvement on the main measure of improved disease-free surviv

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Study examines cancer’s effects on young women’s employment and finances

Scienmag

Cancer and its treatment can impact an individual’s ability to work, and employment disruptions can lead to financial hardships. A new study indicates that women who were diagnosed with cancer as adolescents or young adults can be especially vulnerable to these effects. The findings are published early online in CANCER, a peer-reviewed journal of the […].

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Researchers Use Masimo ORi™, Oxygen Reserve Index, to Predict the Need for Postoperative Oxygen Therapy in Pediatric Patients with Obstructive Sleep Apnea

BioTech 365

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the findings of an abstract recently presented at ANESTHESIOLOGY® 2020, the Annual Meeting of the American Society of Anesthesiologists (ASA).

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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NFL teams with critical mass of women executives have fewer football player arrests

Scienmag

Research from Syracuse University’s Falk College shows that a new philosophy and corporate makeup helps keep players on the field and out of the police blotter Keeping players on the field and out of the courtroom is key for a team’s success. A new study provides a possible pathway to reduce off-the-job player misconduct and […].

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InnoCare Appoints Dr. Manish Tandon as Vice President of Business Development

BioTech 365

BEIJING–(BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a clinical stage biopharmaceutical company, announced today that the Company has appointed Dr. Manish Tandon as Vice President of Business Development, reporting to the Co-founder, Chairman and CEO, Dr. Jasmine Cui. Dr.

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Transgender people who experience discrimination likelier to have poor mental health

Scienmag

Protective factors, such as support from friends, family, and the community, appeared to mitigate the negative impact of discrimination and stigma A University of Waikato study has found that transgender people who have experienced stigma, including harassment, violence, and discrimination because of their identity are much more likely to have poor mental health outcomes.

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Safety and Efficacy of Subcutaneous Entyvio® (Vedolizumab) Sustained During Long-term Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis

BioTech 365

Interim analysis from VISIBLE OLE study showed long-term findings consistent with the known safety profile of vedolizumab with maintained rates of clinical remission and corticosteroid-free clinical remission Entyvio® was the first maintenance biological therapy approved across Europe in both intravenous … Continue reading →

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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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Which pharmaceutical drugs have the most drug patents in Spain?

Drug Patent Watch

This chart shows the drugs with the most patents in Spain. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Spain? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Bone Therapeutics to present at 2020 Virtual Cell & Gene Meeting on the Mesa

BioTech 365

Gosselies, Belgium, 12 October 2020, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announce that CEO, Miguel Forte, MD, PhD will present at the … Continue reading →

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Moms report mild to high levels of COVID-19 anxiety and insomnia in study by Ben-Gurion University

Scienmag

BEER-SHEVA, Israel — Many mothers are experiencing an increase in insomnia severity and mild-to-high levels of acute COVID?19 anxiety, according to a new study by researchers at Ben-Gurion University of the Negev and The Max Stern Yezreel Valley College in Israel. “In the study, we addressed, for the first time, consequences of the COVID?

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Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor

BioTech 365

Formycon AG / Key word(s): Capital Increase/Corporate Action Formycon places Cash Capital Increase of 25.75 Million Euros with Strategic Investor 12-Oct-2020 / 06:30 CET/CEST Disclosure of an inside information acc.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.