Mon.Mar 15, 2021

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The Apple Watch in clinical trials: Current uses and future possibilities

Bio Pharma Dive

Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials.

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PCR Buffer: Polymerase Chain Reaction Mediator

Pharma Mirror

PCR buffer is a vital component of the Polymerase Chain Reaction, also called molecular photocopying. The reaction has helped scientists worldwide study DNA by providing its ample amount from minimal samples. It is almost impossible to carry on a PCR reaction without a buffer. But what is the main function of a PCR Buffer? How does it help in creating DNA copies?

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Lilly lays out 2-year plan to gain approval for Alzheimer's drug

Bio Pharma Dive

Study results for donanemab showed signs of slowing disease progression, but the company believes the FDA won't review until another study confirms that apparent benefit.

Drugs 297
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AZ’s vaccine safety review shows ‘no evidence’ of an increased risk of blood clots

Pharma Times

Review included available safety data from over 17 million people vaccinated in the EU and UK with COVID-19 jab

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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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Gilead, Merck combine forces in HIV

Bio Pharma Dive

The rivals are now working together on oral and injectable treatments that combine their closely watched experimental drugs lenacapavir and islatravir.

Drugs 314
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Novavax confirms efficacy of COVID-19 jab against UK variant

pharmaphorum

A clinical trial has found that Novavax’ COVID-19 vaccine is 86% protective against the UK variant of SARS-CoV-2, only slightly lower than the 96% efficacy seen with the original strain of the virus. . The phase 3 trial – which takes Novavax’ NVX?CoV2373 shot a step closer to approval – also found that it was 100% effective in preventing severe COVID-19.

More Trending

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Ireland, Netherlands suspend AstraZeneca COVID-19 vaccinations

pharmaphorum

Ireland and the Netherlands have joined Norway, Denmark, Bulgaria and Iceland in suspending vaccinations with Oxford/AstraZeneca’s COVID-19 vaccine, shortly after the World Health Organization came out in support of the shot. . In a statement, Ireland’s chief medical officer Dr Ronan Glynn said that vaccinations would be “temporarily deferred” from the morning of Sunday 14 March “following new information received from the Norwegian Medicines Agency” Glynn says Norway’s regulatory authorit

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AstraZeneca says 'no evidence' linking vaccine to clots after multiple countries pause rollout

Bio Pharma Dive

The drugmaker defended its shot following reports of blood clots among vaccine recipients, noting more than 17 million people in the U.K. and Europe have now received it.

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AbbVie Could Sell Off $5 Billion Portfolio of Women’s Drugs

BioSpace

One year after AbbVie’s $63 billion purchase of Allergan, the company is reportedly lining up the sale of a portfolio of women’s drugs and health care products valued at $5 billion.

Drugs 75
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Paving the way towards the biomanufacturing facility of the future

Bio Pharma Dive

Technologies that enable bioprocessing 4.0 are creating the roadmap to the facility of the future.

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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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Biotechs Have Busy Week of Financing Rounds

BioSpace

Yesterday marked the close of three new financing rounds in the biotech space. Although none of today’s are that large, there is still plenty of money on the move. Here’s a look.

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Sysco Sues JBS, Tyson Foods and Others for Alleged Price-Fixing of Pork

XTalks

Distributing giant Sysco filed a lawsuit last week against major US pork producers JBS, Tyson Foods, Hormel Foods and Smithfield Foods, among others, alleging a collaborative price-fixing scheme. Sysco’s antitrust complaint accused the group of pork producers of artificially driving up prices, which resulted in business losses, since as far back as 2009.

Sales 98
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Be Bio Brings in New Talent for Top Roles

BioSpace

Five months after Be Biopharma launched with $52 million in Series A financing, the company tapped bluebird bio veteran Joanne Smith-Farrell as its new chief executive officer.

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No evidence of vaccine increasing blood clot risk: AstraZeneca

BioPharma Reporter

As the Netherlands becomes the latest country to temporarily pause the use of the COVID-19 Vaccine AstraZeneca in its vaccination program, the company stressed the safety of the jab, based on scientific evidence.

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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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Lessons learned in Burkina Faso can contribute to a new decade of forest restoration

Scienmag

In 2018, the West African nation decided to restore 5 million hectares of degraded land by 2030. New research shows what works – and what doesn’t – when restoration coincides with degraded landscapes, pressure on natural resources and climate change Credit: Alliance of Bioversity and CIAT/B.Vinceti Forest landscape restoration is attaining new global momentum this […].

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Data Suggests UK COVID-19 Strain Increases Risk of Death By More Than 60%

BioSpace

A study published in the journal Nature suggest the U.K. strain may cause a 61% higher risk of 28-day mortality.

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Saarbrücken based bioinformaticians trace down molecular signals of Parkinson’s disease

Scienmag

Credit: Oliver Dietze In their study, which is now published in the journal Nature Aging, they show that the level of non-coding RNAs in the blood of a Parkinson’s patient can be used to track the course of the disease. For their study, the team led by bioinformatics professor Andreas Keller and his doctoral student […].

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CRISPR Screening IDs Host Factors Essential for Coronavirus Entry into Cells

BioSpace

Identifying the common host factors that are essential for coronavirus replication is an important element in developing broad-spectrum, antiviral therapeutics.

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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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Cambridge Sleep Sciences and Parkinson’s Concierge to test sleep device in Parkinson’s disease

Pharma Times

SleepHub device to be assessed in people with Parkinson's associated sleep issues

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How vaccine manufacturers can prepare for the next pandemic

BioPharma Reporter

mRNA technology enabled rapid SARS-CoV-2 vaccine development. How can the biopharmaceutical industry improve before the next pandemic?

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UIC researchers discover hidden link between cellular defense systems

Scienmag

Credit: Photo provided by researchers Researchers at the University of Illinois Chicago have discovered that heparanase, HPSE, a poorly understood protein, is a key regulator of cells’ innate defense mechanisms. Innate defense responses are programmed cellular mechanisms that are triggered by various danger signals, which have been conserved in many species throughout evolution.

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ExeVir Snags $50 Million to Take Llama Antibody into First In-Human Trials

BioSpace

German shepherds take down bad guys, dalmatians pull people from fires, beagles sniff out bombs and now llamas fight COVID-19.

Antibody 101
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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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New probe set unravels evolutionary history of second-most diverse group of land plants

Scienmag

Credit: Photos by Emily Sessa. In 2016, a collaborative group of research and education specialists received funding from the National Science Foundation for the project ‘Building a Comprehensive Evolutionary History of Flagellate Plants’ — also known as ‘Genealogy of Flagellate Plants’ (GoFlag). Members of the team have the ambitious goal of reconstructing the 470-million-year history […].

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Sanofi, Regeneron’s Libtayo improves survival in cervical cancer patients

Pharma Times

Phase III trial stopped early for positive result on overall survival

Trials 121
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Novartis says £1.8m Zolgensma is model for gene therapy pricing

pharmaphorum

Novartis has said its gene therapy pricing model, involving a steep one-off payment, could be a template for the hundreds of similar treatments that could follow its Zolgensma for Spinal Muscular Atrophy (SMA). . Zolgensma (onasemnogene abeparvovec) has a list price of £1,795,000 excluding VAT in the UK, but Novartis says the price is justified by the clinical data it has gathered, showing the treatment is particularly effective at reducing symptoms in babies if given early.

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2021 Biopharma Update on the Novel Coronavirus: March 16

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 16, 2021.

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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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Migration routes of one of Britain’s largest ducks revealed for the first time

Scienmag

Much still remains a mystery as to the Shelduck’s migration Credit: ©Philip Croft/BTO New research, just published in the journal Ringing & Migration, has used state of the art tracking technology to investigate how one of Britain’s largest ducks, the Shelduck, interacts with offshore wind turbines during their migration across the North Sea.

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Janssen's Psoriatic Arthritis Drug Proves Long-Term Efficacy in Two-Year Trial

BioSpace

Long-term data from Janssen’s Phase III DISCOVER-2a trial show that TREMFYA® (guselkumab), a selective IL-23 inhibitor, lead to skin clearance and joint symptom relief for up to two years in patients with active psoriatic arthritis.

Trials 75
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Dystonia Medical Research Foundation and Frontiers launch new Open Access journal

Scienmag

Credit: Dystonia Medical Research Foundation The Dystonia Medical Research Foundation (DMRF) has officially selected Frontiers as the publishing partner of its new Gold Open Access journal, Dystonia. The journal will shine a spotlight on the global research effort for a greater understanding of dystonia, as well as breakthroughs in basic, clinical and translational research in […].

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Home health monitoring provides valuable patient insights: Current Health

Outsourcing Pharma

A leader from the trial solutions provider discusses how the COVID-19 pandemic has accelerated the already growing interest in remote patient monitoring.

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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.