Sun.Oct 18, 2020

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Vanquishing COVID-19 by Decreasing Viral Inoculum

BioSpace

Dr. Monica Gandhi, MD, an infectious diseases doctor and professor of medicine at UC San Francisco, poses the hypothesis that masks and other social distancing measures may reduce the viral inoculum – or amount – of the SARS-CoV-2 we contract.

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CBD helps reduce lung damage from COVID by increasing levels of protective peptide

Scienmag

Credit: Kim Ratliff, Production Coordinator, Augusta University One way CBD appears to reduce the “cytokine storm” that damages the lungs and kills many patients with COVID-19 is by enabling an increase in levels of a natural peptide called apelin, which is known to reduce inflammation and whose levels are dramatically reduced in the face of […].

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Pfizer: Expanding North Carolina Gene Therapy Facility and Adding Jobs

BioSpace

Pfizer is continuing to invest in gene therapy research and development and other areas going on throughout the company, specifically in its North Carolina sites in Chapel Hill and Kit Creek.

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Mystery over decline in sea turtle sightings

Scienmag

Credit: Rod Penrose, MEM The number of sea turtles spotted along the coasts of the UK and Ireland has declined in recent years, researchers say. University of Exeter scientists studied records going back more than a century (1910-2018) and found almost 2,000 sea turtles had been sighted, stranded or captured. Recorded sightings increased dramatically in […].

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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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Keytruda Flexes its Muscle in Long-Term Lung Cancer Studies

BioSpace

New data presented at the IASLC 2020 North America Conference on Lung Cancer shows a combination of Keytruda with other medications has a positive impact on non-small cell lung cancer.

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New study shows how complex metabolism may have self-assembled from simple precursors

Scienmag

New research shows that simple environmental reactions can form reactive thioesters similar to those used in modern biology to transduce energy, and this may have served as a way to kick-start the evolution of more complex modern biochemistry Credit: Sebastian Sanden, ELSI. All modern life uses energy to reproduce itself. During this process, organisms build […].

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Losing flight had huge benefits for ants, finds new study

Scienmag

Credit: Philip Gronski Ants are one of the most successful groups of animals on the planet, occupying anywhere from temperate soil to tropical rainforests, desert dunes and kitchen counters. They’re social insects and their team-working abilities have long since been identified as one of the key factors leading to their success. Ants are famously able […].

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Catalyst Continues Legal War Against Jacobus Pharmaceuticals

BioSpace

Catalyst Pharmaceuticals has filed new patent infringement lawsuits against Jacobus Pharmaceuticals and PantherRX Rare LLC over a treatment for the rare autoimmune disease Lambert-Eaton Myasthenic Syndrome.

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All-female scientific coalition calls for marine protected area for Antarctica Peninsula

Scienmag

Plus other ways to help penguins, whales, and seabirds Credit: Will Rogan The Western Antarctic Peninsula is one of the fastest warming places on earth. It is also home to threatened humpback and minke whales, chinstrap, Adélie and gentoo penguin colonies, leopard seals, killer whales, seabirds like skuas and giant petrels, and krill – the […].

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Beckman Coulter Receives Grant to Detect Serious COVID-19 Complication in Kids

BioSpace

The grant was awarded by the U.S. Dept. of Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA).

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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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Asymptomatic and Presymptomatic SARS-CoV-2 Infection Rates in a Multistate Sample of Skilled Nursing Facilities

JAMA Internal Medicine

This cross-sectional study examines the prevalence of asymptomatic and presymptomatic severe acute respiratory syndrome coronavirus 2 infection in skilled nursing facilities.

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FDA Action Alert: Zosano, Spectrum, Regeneron, Kala and Merck

BioSpace

The U.S. Food and Drug Administration has several PDUFA dates for the rest of October, although two of them were already approved. Here’s a look.

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Early-arriving endangered Chinook salmon take the brunt of sea lion predation

Scienmag

Credit: LE Baskow The Columbia River is home to one of the West Coast’s most important Chinook salmon runs. Through late spring and early summer, mature fish return from the sea and begin their arduous journey upriver to spawn. In recent years, these fish have faced an additional challenge: hungry California sea lions. A new […].

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Roche's Venclexta Granted Full Approval Under Project Orbis and Real-Time Review

BioSpace

The U.S. FDA granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.

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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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Creating perfect edges in 2D-materials

Scienmag

Credit: Alexander Ericson/Yen Strandqvist/Chalmers University of Technology Ultrathin materials such as graphene promise a revolution in nanoscience and technology. Researchers at Chalmers University of Technology, Sweden, have now made an important advance within the field. In a recent paper in Nature Communications they present a method for controlling the edges of two-dimensional materials using a […].

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Clinical Catch-Up: October 12-16

BioSpace

It was another busy week for both COVID-19-related clinical trial news as well as trial updates for other indications. Here’s a look.

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Pfizer: Expanding North Carolina Gene Therapy Facility and Adding Jobs

The Pharma Data

In anticipation of our Pfizer Gene Therapy Career Event scheduled for Wednesday, October 28, 2020, BioSpace spoke with Alison Ricci, Pfizer’s Senior Business HR Partner- Global Sciences, Business HR for Bioprocess Research and Development, and HR Site Lead for the company’s four locations in Chapel Hill and Morrisville, North Carolina, Chesterfield, Missouri and Lake Forest, Illinois. .

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New patent expiration for Sb Pharmco drug AVANDARYL

Drug Patent Watch

Annual Drug Patent Expirations for AVANDARYL Avandaryl is a drug marketed by Sb Pharmco and is included in one NDA. There is one patent protecting this drug and two Paragraph…. The post New patent expiration for Sb Pharmco drug AVANDARYL appeared first on DrugPatentWatch - Make Better Decisions.

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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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MED-EL: First Surgeries Ever in Europe with a Totally Implantable Cochlear Implant

The Pharma Data

INNSBRUCK, Austria , Oct. 19, 2020 /PRNewswire/ — Leading hearing implant manufacturer MED-EL sets another revolutionary milestone in its long-standing history of technological innovations. On 24 September, the first person in Europe received a novel totally implantable cochlear implant (TICI). It was implanted by Prof. Dr. Philippe Lefebvre , head of the ENT Department of the CHU of Liège and Professor at the University of Liège in Belgium within a feasibility study.

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New patent expiration for Sb Pharmco drug AVANDIA

Drug Patent Watch

Annual Drug Patent Expirations for AVANDIA Avandia is a drug marketed by Sb Pharmco and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent expiration for Sb Pharmco drug AVANDIA appeared first on DrugPatentWatch - Make Better Decisions.

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New Study from NIH Finds Nicotinamide Riboside Helps Improve Telomere Dysfunction in Human Cells, Mice

The Pharma Data

Oct. 19, 2020 10:32 UTC. LOS ANGELES–( BUSINESS WIRE )– ChromaDex Corp. (NASDAQ:CDXC) today highlighted a new study published in The European Molecular Biology Organization Journal looking at the effect of nicotinamide riboside (NR) on maintaining telomeres, the protective regions at the end of DNA strands. This study is the first to show that by increasing NAD + , NR helped protect telomeres which are important in addressing life-threatening telomere-related diseases, paving the way

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Genesis Therapeutics and Genentech Enter AI-Driven Drug Discovery Collaboration

BioSpace

In this multi-target partnership, Genentech will leverage Genesis’ Dynamic PotentialNet AI platform and other novel neural network algorithms.

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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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Eurofins U.S. Clinical Diagnostics Network Receives EUA Approval of At Home COVID-19 Test

The Pharma Data

Oct. 19, 2020 05:05 UTC. LUXEMBOURG–( BUSINESS WIRE )– Eurofins U.S. Clinical Diagnostics , announced that Clinical Enterprise Inc. has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their at Home COVID-19 Nasal PCR Test. The EUA authorized self-collection kit gives consumers a minimally invasive, convenient and quick option to test from the comfort of their home.

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Big babies could be at higher risk of common heart rhythm disorder in adulthood

Scienmag

Beijing, China 19 Oct 2020: Elevated birth weight is linked with developing atrial fibrillation later in life, according to research presented at the 31st Great Wall International Congress of Cardiology (GW-ICC). GW-ICC 2020 is a virtual meeting during 19 to 25 October. Faculty from the European Society of Cardiology (ESC) will participate in joint scientific […].

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NIH to Test Three Immune Modulators to Treat COVID-19 Cytokine Storm | 2020-10-18

The Pharma Data

The National Institutes of Health (NIH) is starting a late-stage trial of two existing drugs and one investigational agent to assess their potential to control cytokine storm, an immune system overreaction in COVID-19 patients. NIH announced Friday that it has zeroed in on three candidates, Johnson & Johnson’s Remicade (infliximab), Bristol Myers Squibb’s Orencia (abatacept) and AbbVie’s investigational agent cenicriviroc (CVC).

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Suicide prevention in COVID-19 era

Scienmag

What The Article Says: COVID-19 presents a new and urgent opportunity to focus political will, federal investments, and global community on the vital imperative of suicide prevention. Suicide prevention in the COVID-19 era requires addressing not only pandemic-specific suicide risk factors, but also prepandemic risk factors. Authors: Christine Moutier, M.D., of the American Foundation for Suicide Prevention […].

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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.

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UK Moves Closer to Human Challenge Trial for COVID-19 Vaccine | 2020-10-18

The Pharma Data

UK-based contract research organization Open Orphan said it is in advanced negotiations with the British government and other partners for a human challenge trial of a COVID-19 vaccine. Open Orphan subsidiary hVIVO will conduct the UK challenge trial, in which volunteers will be infected with the coronavirus to evaluate the vaccine candidate’s efficacy.

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IVF success rates higher at clinics that provide more outcomes data

Scienmag

AURORA, Colo. (Oct. 18, 2020) – Success rates for in vitro fertilization are higher at clinics that voluntarily share more information than required by government regulators, according to new research by faculty at the University of Colorado School of Medicine. In a review of data reported between 2014 and 2017, CU researchers found that clinics […].

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Celebrate Autumn Traditions Without Raising Your COVID Risk

The Pharma Data

SUNDAY, Oct. 18, 2020 — As the weather gets cooler and social activities move indoors, Americans need to take steps to prevent the spread of the new coronavirus, an expert says. “We now know that if we are going to socialize with people who are not in our household — or in our pandemic pod — being outside or in a well-ventilated space is better than being inside without outside air circulation,” said Lisa Lee, a public health expert at Virginia Tech University.

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Disclosure of received notification of Kabouter Management LLC

BioTech 365

Regulated informationNazareth (Belgium)/Rotterdam (The Netherlands), 19 October 2020 Disclosure of received notification of Kabouter Management LLC Pursuant to the Belgian law of 2 May 2007 regarding the disclosure of major shareholdings in listed companies, Fagron received a notification of Kabouter … Continue reading →

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.