Sun.Feb 21, 2021

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Tweaked COVID-19 Vaccine Starts Phase II for GSK, Sanofi

BioSpace

The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.

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There is no one-size-fits-all road to sustainability on “Patchwork Earth”

Scienmag

Science and policy need to incorporate diversity and complexity of the world when thinking about a sustainable future Credit: McGill University In a world as diverse as our own, the journey towards a sustainable future will look different depending on where in the world we live, according to a recent paper published in One Earth […].

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AstraZeneca Withdraws U.S. Use of Imfinzi as Advanced Bladder Cancer Treatment

BioSpace

AstraZeneca will voluntarily withdraw the use of its checkpoint inhibitor Imfinzi (durvalumab) as a treatment for bladder cancer in the United States following a failure to meet endpoints in a post-approval clinical study.

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Colorful connection found in coral’s ability to survive higher temperatures

Scienmag

Credit: Daisuke Kezuka. Coral within the family Acropora are fast growers and thus important for reef growth, island formation, and coastal protection but, due to global environmental pressures, are in decline A species within this family has three different color morphs – brown, yellow-green, and purple, which appear to respond differently to high temperatures Researchers […].

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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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Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval

JAMA Internal Medicine

This cohort study assesses the concordance between cancer drug indications receiving accelerated approval from the US Food and Drug Administration between 1992 and 2017 and those subsequently authorized for funding through the National Health Service in England.

Drugs 68
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Bioengineered hybrid muscle fiber for regenerative medicine

Scienmag

Regeneration of muscle tissue was achieved by combining direct cell reprogramming with natural-synthetic hybrid scaffold as structural support Credit: Institute for Basic Science Muscle is the largest organ that accounts for 40% of body mass and plays an essential role in maintaining our lives. Muscle tissue is notable for its unique ability for spontaneous regeneration. […].

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Drones used to locate dangerous, unplugged oil wells

Scienmag

Credit: Binghamton University, State University of New York BINGHAMTON, NY — There are millions of unplugged oil wells in the United States, which pose a serious threat to the environment. Using drones, researchers from Binghamton University, State University of New York have developed a new method to locate these hard-to-locate and dangerous wells.

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Placebo—the Unknown Variable in a Controlled Trial

JAMA Internal Medicine

This Viewpoint discusses how improper matching of placebos to experimental drugs in controlled trials can lead to underreporting of harms, confounding, and misleading trial outcomes.

Trials 57
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Study of auto recalls shows carmakers delay announcements until they ‘hide in the herd’

Scienmag

Credit: Indiana University BLOOMINGTON, Ind. – Automotive recalls are occurring at record levels, but seem to be announced after inexplicable delays. A research study of 48 years of auto recalls announced in the United States finds carmakers frequently wait to make their announcements until after a competitor issues a recall – even if it is […].

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Ipsen Announces New Data from the Phase II CLARINET FORTE Study Which Demonstrated Preservation of Quality of Life When Increasing Dose Frequencies of Somatuline® Autogel® (lanreotide)

BioTech 365

Ipsen Announces New Data from the Phase II CLARINET FORTE Study Which Demonstrated Preservation of Quality of Life When Increasing Dose Frequencies of Somatuline® Autogel® (lanreotide) Ipsen Announces New Data from the Phase II CLARINET FORTE Study Which Demonstrated Preservation … Continue reading →

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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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New study on the forecasting of extreme rainfall events in Mediterranean countries

Scienmag

Researchers at the European Center for Medium-range Weather Forecasts and TU Freiberg develop a framework to better predict extreme rainfall events in Mediterranean countries Credit: Mastrantonas et al, 2020 Extreme rainfall has devastating consequences for societies and economies. Locations around the Mediterranean are frequently affected by such events, leading to landslides and floods. “It is, […].

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Dr. Reddy’s Laboratories Announces the Launch of Lansoprazole DR Orally Disintegrating Tablets in the U.S. Market

BioTech 365

Dr. Reddy’s Laboratories Announces the Launch of Lansoprazole DR Orally Disintegrating Tablets in the U.S. Market Dr. Reddy’s Laboratories Announces the Launch of Lansoprazole DR Orally Disintegrating Tablets in the U.S. Market HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr.

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Pioneering research reveals gardens are secret powerhouse for pollinators

Scienmag

Credit: Nicholas Tew Home gardens are by far the biggest source of food for pollinating insects, including bees and wasps, in cities and towns, according to new research. The study, led by the University of Bristol and published today in the Journal of Ecology, measured for the first time how much nectar is produced in […].

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NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy

BioTech 365

NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines … Continue reading →

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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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Rapid evolution may help species adapt to climate change and competition

Scienmag

Credit: Washington State University VANCOUVER, Wash. – Loss of biodiversity in the face of climate change is a growing worldwide concern. Another major factor driving the loss of biodiversity is the establishment of invasive species, which often displace native species. A new study shows that species can adapt rapidly to an invader and that this […].

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Clinical Catch-Up: February 15-19

BioSpace

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

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New model helping identify pregnant women whose previous kidney injury puts them, babies at risk

Scienmag

Credit: Kim Ratlliff, Augusta University photographer Young pregnant women, who appear to have fully recovered from an acute injury that reduced their kidney function, have higher rates of significant problems like preeclampsia and low birthweight babies, problems which indicate their kidneys have not actually fully recovered. Now scientists have developed a rodent model that is […].

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Rapid Nutrition PLC: Rapid Nutrition Launches New Investor Relations Website

BioTech 365

EQS Group-News: Rapid Nutrition PLC / Key word(s): Miscellaneous 22.02.

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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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Life from Earth could temporarily survive on Mars

Scienmag

Study shows sending microbes to Earth’s stratosphere, to test their endurance to Martian conditions, can reveal their potential use and threats to space travel Credit: NASA Some microbes on Earth could temporarily survive on the surface of Mars, finds a new study by NASA and German Aerospace Center scientists. The researchers tested the endurance of […].

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Which pharmaceutical companies have the most ointment dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most ointment dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most ointment dosed drugs…. The post Which pharmaceutical companies have the most ointment dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Acid reflux disease may increase risk of cancers of the larynx and esophagus

Scienmag

Results from a large prospective study indicate that gastroesophageal reflux disease (GERD), which also causes heartburn symptoms, is linked with higher risks of various cancers of the larynx (or voice box) and esophagus. The study is published early online in CANCER, a peer-reviewed journal of the American Cancer Society. GERD, a gastrointestinal disorder that affects […].

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Investment needed to bring down pancreatic cancer death rates in Europe

Scienmag

Researchers predict over 1.4 million deaths from top 10 cancers in 2021 in the EU and UK; accompanying editorial warns of adverse effect of COVID-19 on death rates Researchers have called on European policymakers to make adequate resources available to tackle pancreatic cancer, a disease that is almost invariably fatal and where little progress has […].

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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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Low-quality maternal diet during pregnancy may be associated with late-childhood obesity

Scienmag

Eating a low quality diet, high in foods and food components associated with chronic inflammation, during pregnancy may be associated with an increased risk of obesity and excess body fat in children, especially during late-childhood. The findings are published the open access journal BMC Medicine. Researchers from University College Dublin, Ireland found that children of […].

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Experts on genomics convene for virtual Mutational Scanning Symposium April 5 – 7

Scienmag

‘Exploring one of the biggest challenges facing genomics today – understanding genetic variants’ SEATTLE (February 22, 2021) – Global experts performing leading edge research in precision medicine, functional genomics, protein science, and variant interpretation and prediction will share their expertise and insights April 5-7 during the fourth annual “Mutational Scanning Symposium,” a free-of-charge virtual conference. […].

Genome 40
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Stress was leading reason teachers quit before pandemic, and COVID has made matters worse

Scienmag

Stress was the most common reason teachers cited for leaving the profession before and during the pandemic, according to a RAND Corporation survey of nearly 1,000 former public-school teachers. Three of four former teachers said work was often or always stressful in the most recent year in which they taught in a public school. In […].

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Music is a must for young drivers, according to Ben-Gurion U. researchers

Scienmag

BEER-SHEVA, Israel…February 22, 2021 – A new study by Ben-Gurion University of the Negev (BGU) researchers resulted in a nearly unanimous response: driving is “absolutely impossible” without music. “To young drivers 18-29, music in the car isn’t just entertainment, it’s part of their autosphere whether they’re alone or not,” says Prof.

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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.