Wed.Aug 12, 2020

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FDA gives speedy approval to another Duchenne drug

Bio Pharma Dive

Viltepso, from Japanese drugmaker NS Pharma, is approved to treat the same subset of Duchenne patients as Sarepta's Vyondys 53.

Drugs 337
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How Antiarrhythmic Drugs are Used in Cardiac Life Support

Pharma Mirror

One of the most interesting types of cardiovascular pharmaceuticals around is antiarrhythmic drugs, which can change the way your heartbeats. Antiarrhythmic drugs help counteract abnormal heart rhythms resulting from the irregular electrical activity. These could include atrial fibrillation, atrial flutter, supraventricular tachycardia, and Wolff-Parkinson-White syndrome, among others.

Drugs 130
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Bristol Myers pledges to spend $300M on addressing racial, health disparities

Bio Pharma Dive

The drugmaker aims to double Black and Latinx representation in its executive ranks, among other commitments.

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Medical Face Shield Sales Can Soar Dramatically as Airborne Transmission Become a Real Threat

Pharma Mirror

Medical face shield can become as ubiquitous as masks, as new findings on the airborne spread of Covid-19 influence behavior and guidelines. According to a latest study by Future Market Insights, medical face shields market will grow at over 11% CAGR through 2030. Medical face shields prove to be an effective means for first line protection against.

Sales 130
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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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American Gene Technologies Gets Go-Ahead to Test Possible HIV Cure

BioSpace

American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.

Gene 145
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Finding resilience after an HIV diagnosis

pharmaphorum

Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. He tells pharmaphorum about the importance of resilience in coping with a serious illness. John first began writing about HIV/AIDS as a journalist in 1986. “I had two friends of mine in their 20s die from AIDS while I was in journalism school in 1985 – a time when AIDS was always in the news and there was a lot

Doctors 128

More Trending

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Digital depression therapy offers hope during COVID-19 pandemic

pharmaphorum

A new digital therapy is aiming to tackle depression during the COVID-19 pandemic, using a brain stimulation headset and therapy app that claims to have similar beneficial effects to drugs but with fewer side-effects. Flow is the first drug-free at-home treatment of its type to be approved in the EU and UK. While using the Flow headset, patients engaged with a therapy app program, which offers personalised behavioural therapy in areas proven to reduce symptoms of depression, including nutrition,

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FDA Approves NS Pharma’s Viltepso for Duchenne Muscular Dystrophy

BioSpace

The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).

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NHS looks for digital pioneers to reshape services during pandemic

pharmaphorum

A fellowship programme is looking for digital pioneers to design and lead service transformation projects in England’s NHS as the COVID-19 pandemic continues. DigitalHealth.London opens applications to its Digital Pioneer Fellowship programme, supporting change makers employed by NHS organisations in London to design and lead transformation projects underpinned by digital innovation.

Nurses 98
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Gut Enzymes Show Promise in Helping to Identify Potential Diseases

BioSpace

According to a study published in Nature Communications on August 11, enzymes that are used by bacteria to break down mucus in the gut can potentially be useful biomarkers for intestinal diseases.

Bacteria 135
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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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Swallowing this colonoscopy-like bacteria grabber could reveal secrets about your health

Scienmag

Credit: Purdue University photo/Mark Simons Your gut bacteria could say a lot about you, such as why you’re diabetic or how you respond to certain drugs. But scientists can see only so much of the gastrointestinal tract to study the role of gut bacteria in your health. What comes out of you is just a […].

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Clinical Transparency Proponents Question Safety and Efficacy of Russia’s COVID-19 Vaccine

BioSpace

While Russian President Vladimir Putin expressed confidence in the preventative medication against the novel coronavirus, scientists from across the globe expressed concern over the lack of available data.

Scientist 123
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NSF CAREER award to study engineering pathways for Appalachian youth

Scienmag

Credit: Virginia Tech Jacob Grohs believes that teachers and their school systems, universities, and companies are uniquely positioned to come together and create positive engineering experiences for students. Through the Virginia Tech Partnering with Educators and Engineers in Rural Schools (VTPEERS) initiative, funded by the National Science Foundation, Grohs is working with teachers in rural […].

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Chiesi’s flagship Fabry drug heads for FDA verdict in early 2021

pharmaphorum

The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by 27 January. The enzyme replacement therapy (ERT) – also known as PRX-102 – has been granted a priority review by the US regulator, and is the top prospect in Chiesi’s recently formed rare diseases division.

Drugs 98
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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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Preliminary study of 300+ COVID-19 patients suggests convalescent plasma therapy effective

Scienmag

American Journal of Pathology publishes efficacy results from Houston Methodist clinical trial Credit: Houston Methodist HOUSTON-(Aug. 12, 2020) – A preliminary analysis of an ongoing study of more than 300 COVID-19 patients treated with convalescent plasma therapy at Houston Methodist suggests the treatment is safe and effective. The results, which appear now in The American […].

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How to Write a Great Interview Follow-up Email

BioSpace

While the interviewers will undoubtedly place more weight on your interview than anything else, writing a follow-up email that expresses your enthusiasm for the position and competence for the available role can help you stand out.

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Public health consequences of policing homelessness

Scienmag

Credit: UNSPLASH: Photo credits go to Matt Collamer Two weeks ago, Colorado State Patrol troopers began clearing out nearly 200 residents from homeless encampments that surround the Colorado Capitol. The enforcement of city ordinances like camping bans, park curfews and obstructions of public passageways is lawful. But the increase in “tough love” and “quality of […].

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BMS’ Opdivo improves survival in gastric and oesophageal cancers

Pharma Times

Topline results published from CheckMate-649 and CheckMate-577 studies

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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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Warming threat to tropical forests risks release of carbon from soil

Scienmag

Credit: Geetha Iyer Billions of tonnes of carbon dioxide risk being lost into the atmosphere due to tropical forest soils being significantly more sensitive to climate change than previously thought. Carbon emissions from soils in tropical forests – which store one quarter of the world’s soil carbon – could increase dramatically if temperatures continue to […].

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Passage Bio’s Gene Therapy for GM1 Gangliosidosis Hit with Clinical Hold

BioSpace

Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold.

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Zeroing out their own zap

Scienmag

Time-shifted inhibition helps electric fish ignore their own signals Credit: Matasaburo Fukutomi/Tsunehiko Kohashi Electric fish generate electric pulses to communicate with other fish and sense their surroundings. Some species broadcast shorter electric pulses, while others send out long ones. But all that zip-zapping in the water can get confusing.

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Thomson International Recalls Onions Due to Risk of Salmonella

XTalks

Thomson International, a company based out of Bakersfield, California, has recalled red, yellow, white and sweet yellow onions shipped from May 1, 2020 until now due to potential Salmonella contamination. The Public Health Agency of Canada say there are now 239 confirmed cases of Salmonella infections that are linked to onion imports from the United States.

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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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‘Reelin’ in a new treatment for multiple sclerosis

Scienmag

Depleting key protein could protect against conditions marked by chronic inflammation Credit: UT Southwestern Medical Center DALLAS – Aug. 12, 2020 – In an animal model of multiple sclerosis (MS), decreasing the amount of a protein made in the liver significantly protected against development of the disease’s characteristic symptoms and promoted recovery in symptomatic animals, […].

Protein 87
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Gilead aims for approval of COVID-19 drug remdesivir in the US

Pharma Times

Drug has already been approved in the EU and Japan

Drugs 123
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Bird and reptile tears aren’t so different from human tears

Scienmag

Credit: Arianne P. Oriá Bird and reptile tears aren’t so unlike our own, shows a new study in Frontiers in Veterinary Science. But the differences could provide insights into better ophthalmic treatments for humans and animals, as well as a clues into the evolution of tears across different species. “Discovering how tears are able to […].

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FDA Approves Trevena's IV Opioid for Short-Term Acute Pain Management

BioSpace

Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.

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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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Some dinosaurs could fly before they were birds

Scienmag

Updated evolutionary tree and biomechanical estimates of feathered dinosaurs and early birds show powered flight may have evolved in these animals at least three different times Credit: Julius Csotonyi New research using the most comprehensive study of feathered dinosaurs and early birds has revised the evolutionary relationships of dinosaurs at the origin of birds.

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MACHEREY-NAGEL Filterpapier MN 616 LSA-50 – D: 48mm Nr.432110 – 100 Stück

BioTech 365

EUR 154,90Angebotsende: Freitag Aug-28-2020 20:32:18 CESTSofort-Kaufen für nur: EUR 154,90Sofort-Kaufen | Zur Liste der beobachteten Artikel hinzufügen Biotech365 : MACHEREY-NAGEL Filterpapier MN 616 LSA-50 – D: 48mm Nr.

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Coastal flooding study finds trust-building, power-sharing key for environmental justice

Scienmag

It took two years and $11 million, but eventually ranchers, politicians and scientists came to a consensus about how to prevent flooding in Tillamook, a coastal Oregon town. A recent study by Portland State University researchers examining the social factors involved in this decision-making process showcases how environmental justice can be served when affected parties […].

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BioSpace Global Roundup, Aug. 13

BioSpace

Biopharma and life sciences companies from across the globe provide updates on their business and pipelines.

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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.