Mon.May 10, 2021

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Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'

Bio Pharma Dive

Laronde comes equipped with $50 million in funding from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines.

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In the News: April 2021 Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire. The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval.

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FDA authorizes Pfizer's coronavirus vaccine for younger teens

Bio Pharma Dive

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states are beginning to report waning demand.

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Healthcare Staffing: Tips for Recruitment

Pharma Mirror

The success of any healthcare organization depends on its workers. The equipment and structure a hospital or healthcare facility have means nothing if it does not have good workers. This is why most hospitals pay a great deal of attention to their recruiting process. However, the pandemic has made the shortage of healthcare workers even more obvious.

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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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Amgen asks FDA for approval of key asthma drug

Bio Pharma Dive

Tezepelumab is one of Amgen's top experimental medicines and a U.S. OK would help its efforts to offset revenue declines from its aging blockbusters.

Medicine 281
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After Months of Prodding, CDC Updates Guidance on COVID-19 Airborne Transmission

BioSpace

The CDC says that COVID-19 is an airborne threat, stating that transmission and subsequent infection can occur via inhalation of very fine respiratory droplets and aerosolized particles.

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More Trending

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BioNTech to set up mRNA manufacturing site in Singapore

pharmaphorum

BioNTech has said it plans to set up a regional base and new manufacturing site in Singapore so that the biotech can keep pace with demand for its mRNA-based coronavirus vaccine and pipeline products in other disease areas. The German firm said the production facility will be able to produce several hundred million doses of mRNA-based vaccine, depending on the requirements of the specific vaccine.

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Wearables for actigraphy measures in clinical trials

Bio Pharma Dive

It's now possible to gather far more data, more often, more objectively, and more easily than ever before, and, with the appropriate choice, broadly expedite clinical trials utilizing actigraphy measurements.

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Coronavirus won’t be circulating in UK by August, says outgoing vaccine chief Clive Dix

pharmaphorum

Coronavirus won’t be circulating in the UK by August, according to the outgoing chief of the country’s vaccine rollout scheme, Dr Clive Dix. Dix led the programme from December until he stepped down last week and told the Daily Telegraph that the UK’s vaccination campaign should be enough to protect from the virus and its known variants by the summer.

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Researchers find CD38-targeting drugs may show promise against prostate cancer

Pharma Times

Researchers are initiating clinical trials to evaluate whether targeting the CD38 pathway can provide benefit for people with prostate cancer

Research 119
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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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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the heart – with the vaccine.

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AZ/Daiichi Sankyo’s datopotamab deruxtecan demonstrates ‘promising’ early results in TNBC

Pharma Times

New data presented at the 2021 European Society of Medical Oncology (ESMO) Breast Cancer virtual congress

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BioNTech to build mRNA manufacturing facility in Singapore

BioPharma Reporter

BioNTech plans to expand its global footprint with a regional headquarters for South East Asia in Singapore; as well as a fully integrated mRNA manufacturing facility.

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How a lack of mental health diagnosis is affecting young men

pharmaphorum

As lockdown gradually eases, things are starting to look up but the lasting impact COVID-19 has had on our wellbeing remains. During Mental Health Awareness Month we look at the mental health stigma amongst men. To say we’re in the midst of a mental health crisis is not an exaggeration. Mental health concerns have been increasing for years and have only been amplified by the COVID-19 crisis and national lockdowns.

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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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New COVID-19 Vaccine on the Block Displays Multi-Variant Potential

BioSpace

The Infectious Disease Research Institute (IDRI), Duke Human Vaccine Institute, and 3M are working together on a potential vaccine that might protect individuals against multiple variants of SARS-CoV-2.

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Light meets superconducting circuits

Scienmag

Credit: Andrea Bancora, Amir Youssefi (EPFL) In the last few years, several technology companies including Google, Microsoft, and IBM, have massively invested in quantum computing systems based on microwave superconducting circuit platforms in an effort to scale them up from small research-oriented systems to commercialized computing platforms. But fulfilling the potential of quantum computers requires […].

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Laronde sets out to advance Endless RNA: ‘eRNA therapeutics have the potential to be an essential and widespread class of medicines’

BioPharma Reporter

Flagship Pioneering has unveiled Laronde: a platform company developing Endless RNA. Endless RNA is a novel, engineered form of RNA that can be programmed to express therapeutic proteins inside the body: âa groundbreaking therapeutic platform capable of biological applications we could only dream of a few years ago,â according to the founders.

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Positive CHMP opinion for self-administered Crysvita

Pharma Times

Crysvita is used for the treatment of the rare metabolic bone disease X-linked hypophosphataemia (XLH)

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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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The Aqueduct of Constantinople: Managing the longest water channel of the ancient world

Scienmag

Double water channels may have been used to maintain the system while enabling constant operation Credit: photo/©: Jim Crow Aqueducts are very impressive examples of the art of construction in the Roman Empire. Even today, they still provide us with new insights into aesthetic, practical, and technical aspects of construction and use. Scientists at Johannes […].

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Pfizer/BioNTech COVID-19 Vaccine Wins EUA in Young Teens

BioSpace

The U.S. FDA expanded the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after clinical data showed 100% efficacy response.

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Smashing the Covid curve

Scienmag

Scientists at IST Austria show that little differences in behavior decide between success and complete failure of epidemic control. Credit: IST Austria/Nadine Poncioni What has fluid physics to do with the spreading of the Corona virus? Whirlpools and pandemics seem to be rather different things, certainly in terms of comfort. Yet, newest findings about epidemic […].

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FDA Clears Samus Drug for Glioma Phase Ib Study

BioSpace

Clearance of the IND allows Samus to proceed with a Phase Ib trial to assess the safety, tolerability and pharmacokinetics of PU-AD in a small group of patients with recurrent malignant glioma.

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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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Research results challenge a decades-old mechanism of how we hear sounds

Scienmag

Credit: Sanna Hedin Researchers at Linköping University, Sweden, have made several discoveries on the functioning mechanisms of the inner hair cells of the ear, which convert sounds into nerve signals that are processed in the brain. The results, presented in the scientific journal Nature Communications, challenge the current picture of the anatomical organisation and workings […].

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Cystic Fibrosis: One Patient’s Story, Current Treatments and Exciting New Therapies on the Horizon

BioSpace

“The recent progress of cystic fibrosis drugs has been amazing and, in my case, miraculous,” said Kelly Peters, who lives with cystic fibrosis. “The new drugs are not a cure, but they feel pretty close.

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Mediterranean turtles recovering at different rates

Scienmag

Credit: Olkan Erguler Numbers of two Mediterranean turtle species have risen in the last three decades – but in Cyprus the recoveries are happening at different rates, new research shows. Nest counts at 28 beaches show green turtle nests increased by 162% from 1993 to 2019, while loggerhead nests rose by 46%. The research team […].

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Renal-Focused Alebund Pharma Raises $60 Million in Series B Financing Round

BioSpace

Shanghai-based Alebund Pharmaceuticals has raised $60 million in a new Series B financing round that will be harnessed to further drive the company’s focus on renal disease.

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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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Intoxication brings strangers physically closer, study finds

Scienmag

Credit: Photo by Fred Zwicky CHAMPAIGN, Ill. — In a study with pandemic-related implications, researchers report that strangers who consume alcohol together may keep their distance initially – but draw physically closer as they become intoxicated. No previous studies have tested the effects of alcohol consumption on social distance, the researchers say.

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Novavax’s flu / COVID combo vaccine shows ‘robust responses’: Preclinical data

BioPharma Reporter

Novavaxâs combination NanoFlu/NVX-CoV2373 vaccine induced functional influenza and COVID antibodies in preclinical studies, the company has announced.

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Early screening tool leads to earlier diagnosis and treatment for autism spectrum disorder

Scienmag

But in a surprising finding, pediatricians are far more apt to act if parents independently express concerns Credit: Credit: UC San Diego Health Sciences Since it debuted in 2011, the Get SET Early program, which provides pediatricians and parents with a relatively simple process to screen for indicators of autism spectrum disorder (ASD) in children […].

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WHO grants Sinopharm’s COVID-19 vaccine emergency approval

Pharma Times

First COVID-19 jab developed by a non-Western company to gain this recommendation

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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.