Sun.Mar 28, 2021

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Should doctors refuse to treat obese patients?

World of DTC Marketing

IN BRIEF: Doctors are not required to treat obese patients who won’t do anything to lose weight but the problem is more than reminding patients they need to get exercise and drop pounds. One study found that only 50 percent of patients follow the instructions associated with taking their medication, and even fewer implement necessary lifestyle changes suggested by their doctor.

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Caribou Biosciences is Armoring Cells to Fight Disease Through CRISPR

BioSpace

The company’s overarching aim is to edit and equip cells with molecular tools, through CRISPR, to eliminate certain cancers.

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One in five Colorado high school students has access to firearms

Scienmag

New study looks at gun access among adolescents in Colorado Credit: CU Anschutz Medical Camppus Twenty percent of high school students have easy access to a handgun, according to a new study from the Colorado School of Public Health on the University of Colorado Anschutz Medical Campus. In the study published today in The Journal […].

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French Court Fines Servier for Damages Caused by Weight-Loss Drug

BioSpace

Servier was found guilty of manslaughter and deceptive marketing practice for its weight-loss pill Mediator. The Paris-based company was fined $3.12 million following a lawsuit that took years to wind its way through the court system.

Drugs 112
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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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Machine learning helps spot gait problems in individuals with multiple sclerosis

Scienmag

Credit: Photo by L. Brian Stauffer CHAMPAIGN, Ill. — Monitoring the progression of multiple sclerosis-related gait issues can be challenging in adults over 50 years old, requiring a clinician to differentiate between problems related to MS and other age-related issues. To address this problem, researchers are integrating gait data and machine learning to advance the […].

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Orphazyme Drug Misses Both Endpoints in Rare Muscle-Wasting Disease Trial

BioSpace

Orphazyme announced its Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit both its primary and secondary endpoints.

Trials 109

More Trending

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FDA Action Alert: Merck, Aveo and Acadia

BioSpace

As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.

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FDA approvals strengthen Octapharma USA pediatric critical care product portfolio

Scienmag

Octaplas™ and fibryga® receive new product labeling following FDA’s approval of BLA supplements to update therapy research; FDA expands fibryga® indication to include treatment of children under 12 years of age Credit: Octapharma USA PARAMUS, N.J. (March 29, 2021) – The U.S. Food and Drug Administration (FDA) has approved two Octapharma supplements to Biological License […].

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Zero to Hero – Tainted Company Bounces Back with Successful COVID-19 Drug

BioSpace

Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.

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Carried with the wind: mass migration of Larch Budmoth to the Russian High Arctic

Scienmag

Credit: Dr Maria Gavrilo Arctic habitats have fascinated biologists for centuries. Their species-poor insect faunas, however, provide little reward for entomologists – scientists who study insects – to justify spending several weeks or even months in the hostile environments of tundra or polar deserts. As a result, data on insects from the High Arctic islands […].

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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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WHO Report on COVID-19 Origin Focuses on Spread from Wild Animals

BioSpace

The report listed four scenarios in order of likelihood, with the top being from bats through another animal.

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Updating Our Thinking on Troponin Use and Interpretation

JAMA Internal Medicine

Drs Allen and deSouza present the case of a middle-aged man with palpitations and chest pain in the setting of supraventricular tachycardia (SVT). The symptoms resolved when the tachycardia stopped, but a troponin test ordered as part of the initial workup returned elevated results. He was admitted with a non-ST segment elevation myocardial infarction and underwent a coronary catheterization, which showed no obstructive coronary artery disease (CAD).

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NeuroRx Reports Positive RLF-100 Data for Critically Ill COVID-19 Patients

BioSpace

A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.

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More exercise, fewer screens: New Australian guidelines for kids in OSHC

Scienmag

Groundbreaking research from the University of South Australia has delivered world-first national-level guidelines to better inform children’s physical activity and screen time in Outside School Hours Care (OSHC). Developed with input from the OSHC sector, the guidelines aim to address growing concerns of children’s sedentary behaviour marked by an increase in regular screen time.

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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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After Many Delays, BMS and bluebird Win Approval for Multiple Myeloma CAR-T

BioSpace

The FDA approved ide-cel, which will be marketed under the brand name Abecma.

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Contact lenses poised to detect cancer, treat disease and replace digital screens

Scienmag

Newly-published “contact lens technologies of the future” paper reviews innovative uses for disease detection and therapy, drug delivery, vision enhancement and mor Credit: Centre for Ocular Research & Education (CORE) WATERLOO, Ontario, March 29, 2021–A newly-published paper represents one of the most comprehensive reviews of advancements to come in contact lenses, catapulting the commonly-used medical […].

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Alien J-1 Physicians in a Pandemic

JAMA Internal Medicine

This article describes the unique difficulties faced by non-US citizen physicians during the COVID-19 pandemic.

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Caltech professor Ibrahim Cissé applies physics to decode and understand RNA transcription

Scienmag

Nigerien-born physicist is the recipient of a 2021 Vilcek Prize for Creative Promise in Biomedical Science Credit: Image courtesy of the Vilcek Foundation NEW YORK, March 29, 2021–The Vilcek Foundation recognizes the research contributions and work of Caltech professor Ibrahim Cissé in a new article and video. Cissé is the recipient of a 2021 Vilcek […].

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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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5 Myths About Non-Surgical Hair Replacement Report by Folicure Hair Replacement Dallas

BioTech 365

5 Myths About Non-Surgical Hair Replacement Report by Folicure Hair Replacement Dallas 5 Myths About Non-Surgical Hair Replacement Report by Folicure Hair Replacement Dallas In this article, Folicure Dallas addresses myths about nonsurgical hair replacement.

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New patent expiration for Evoke Pharma drug GIMOTI

Drug Patent Watch

Annual Drug Patent Expirations for GIMOTI Gimoti is a drug marketed by Evoke Pharma Inc and is included in one NDA. There are two patents protecting this drug. This drug…. The post New patent expiration for Evoke Pharma drug GIMOTI appeared first on DrugPatentWatch - Make Better Decisions.

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Noninfluenza viruses have rates of illness, death similar to flu

Scienmag

Noninfluenza respiratory viral infections (NIRV) are associated with illness and death rates similar to influenza in hospitalized adults, according to new research in CMAJ (Canadian Medical Association Journal). In a study of 2119 adults admitted to two hospitals over three seasons (2015-2018) in Edmonton, Alberta, and Toronto, Ontario, with confirmed viral acute respiratory infections, more […].

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Results for the year ended 31 December 2020

BioTech 365

Results for the year ended 31 December 2020 Results for the year ended 31 December 2020 This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

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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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SETAC Europe 31st annual meeting

Scienmag

Scientists to present and discuss cutting-edge research in environmental toxicology and chemistry The Society of Environmental Toxicology and Chemistry Europe is organizing its 31st annual meeting, which will be held as a virtual event from 3-6 May and expects to draw over 1,500 scientists from more than 60 countries to discuss the latest research in […].

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Orphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis (IBM)

BioTech 365

Orphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis (IBM) Orphazyme announces topline results from pivotal trial of arimoclomol for Inclusion Body Myositis (IBM) Orphazyme A/SCompany announcement … Continue reading →

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Clinical Catch-Up: March 22-26

BioSpace

There was a fair amount of clinical trial news last week. Here’s a look.

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QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio

BioTech 365

QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio QIAGEN Receives FDA Emergency Use Authorization for NeuMoDx Multiplex Test Expanding COVID-19 Portfolio NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test receives Emergency Use Authorization by FDA The 4-plex test … Continue reading →

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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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Which pharmaceutical companies have the greatest global patent coverage?

Drug Patent Watch

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

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