Tue.Sep 22, 2020

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Blueprint's bet on itself pays off with rare disease drug data

Bio Pharma Dive

Study data show Blueprint's first approved cancer drug, Ayvakit, could also work to treat a rare disease, a result that sent the company's shares higher.

Drugs 286
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Switching to DrugPatentWatch

Drug Patent Watch

Don’t wait until the end of the year to start looking for alternatives to your existing business intelligence providers. DrugPatentWatch can help you replace or supplement your current solutions with:…. The post Switching to DrugPatentWatch appeared first on DrugPatentWatch - Make Better Decisions.

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Regeneron forges ahead in lung cancer, but will need more to unseat Merck

Bio Pharma Dive

The biotech's immunotherapy Libtayo looks headed for approval in lung cancer, but surpassing the bar set by Merck's Keytruda remains a challenge.

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FDA Plans New, More Stringent Guidance for COVID-19 Vaccine EUA

BioSpace

Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections.

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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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FDA decision on Bristol Myers cell therapy could come down to the wire

Bio Pharma Dive

The FDA could decide the fate of Bristol Myers' multiple myeloma treatment ide-cel four days before a key deadline related to the pharma's buyout of Celgene passes.

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Controlling ultrastrong light-matter coupling at room temperature

Scienmag

Credit: Illustration: Denis Baranov, Chalmers University of Technology Physicists at Chalmers University of Technology in Sweden, together with colleagues in Russia and Poland, have managed to achieve ultrastrong coupling between light and matter at room temperature. The discovery is of importance for fundamental research and might pave the way for advances within, for example, light […].

Research 116

More Trending

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Evergreen Theragnostics Breaks Ground on Radiopharmaceutical Factory

BioSpace

The new facility will be 14,000 square feet and is designed from start to finish to meet global current Good Manufacturing Practice (cGMP) standards for radiopharmaceutical manufacturing.

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UK university strikes e-prescribing partnership with Better

pharmaphorum

A UK university has struck a partnership with medical technology firm Better that aims to give nursing and pharmacy students a better insight into e-prescribing. Liverpool John Moores University is to use Better’s OPENeP electronic prescribing and medicines administration software to teach the students about modern prescribing practices. OPENeP is designed as a stand-alone product that allows electronic patient record systems to be integrated with medication-related decision support systems.

Pharmacy 111
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Fitbit Wins Another Approval for AFib App

XTalks

The San Francisco-based tech giant, Fitbit, has received clearance from the US Food and Drug Administration (FDA) and the Conformité Européenne (CE) in the European Union for its electrocardiogram (ECG) app. The application is used to assess heart rhythm for atrial fibrillation (AFib). AFib is an irregular heartbeat, known as arrhythmia, that can lead to blood clots, stroke, heart failure and other heart-related complications.

Gene 107
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New study reveals patients’ changing needs during COVID-19

pharmaphorum

New research from The Patients Association, supported through sponsorship provided by Novo Nordisk and ENGINE MHP, looks at how more than 950 patients experienced the COVID-19 pandemic, with an emphasis on managing and accessing care and their experiences of treatment and services more broadly. Here, Patients Association CEO Rachel Power and ENGINE MHP director Jonathon Sheppard explore some of the findings – such as major disruptions to the relationships between patients and the health and care

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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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4 Things You Might Overlook When Applying for Jobs

BioSpace

Often times, you can fall into a trap of seeing a particular title, skimming a listing, and firing off an application.

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Roles and Responsibilities of a Clinical Research Coordinator

Forte Research Systems®

Clinical Research Coordinators are tasked with many responsibilities throughout the day. Learn more about how to balance each role and responsibility effectively.

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MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food

XTalks

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. The Velco-like device pierces the packaging and the food via silk microneedles that suck in material through capillary action. Once the tiny holes on the needles draw fluid towards the back of the sensor, the analysis occurs.

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Industry should work together to raise public understanding of clinical trials, says Innovative Trials

BioPharma Reporter

AstraZeneca paused its COVID-19 vaccine trial earlier this month for a safety review â generating headlines across mainstream press worldwide. Such pauses are not uncommon in clinical trials â so whatâs the best way to deal with them?

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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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Could Glycans Hold the Key to Attacking Coronavirus at its Source?

BioSpace

A study published today showed that researchers have discovered an active role for glycans, the sugar molecules that decorate proteins. In turn, there may be new targets for certain therapies, and this could help experts looking to develop a vaccine for COVID-19.

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Higher income economies sign up to global Covid-19 vaccine initiative, but not US, China or Russia

BioPharma Reporter

A project run by Gavi, the vaccine alliance, and the World Health Organization (WHO) to guarantee fair access to COVID-19 vaccines worldwide has secured the backing of 64 higher income economies, with a further 38 economies expected to sign in the coming days.

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New Interim Order to expedite the approval of COVID-19 drugs and vaccines

Pharma in Brief

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order ) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.

Drugs 98
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Genmab and Janssen Head to Arbitration Table Over Darzalex Royalties

BioSpace

In a brief statement, Genmab said it initiated binding arbitration related to two matters under its Darzalex (daratumumab) license agreement with Janssen Biotech.

Licensing 101
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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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Startup focused on genomics data joins national health care accelerator

Scienmag

Credit: Karyosoft/Rajesh Perianayagam WEST LAFAYETTE, Ind. – A Purdue Foundry-affiliated company with a growing reputation as a search engine for genome sequence data in life sciences has joined a nationally ranked health care startup accelerator. Karyosoft is among nine startups from across the globe selected for the Dallas-based seed accelerator Health Wildcatters.

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Risk Assessment Tool Identifies Diabetic Patients that Benefit Most from SGLT2 Inhibitor Treatment

XTalks

A new study shows that the diabetic drug canagliflozin reduces the risk of adverse cardiovascular and kidney outcomes in individuals with type 2 diabetes, particularly for those at higher risk of kidney failure. The Canagliflozin Cardiovascular Assessment Study (CANVAS) Program evaluated patients with type 2 diabetes who are at high cardiovascular risk.

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Exercise hormone may modulate genes associated with replication of novel coronavirus

Scienmag

Brazilian researchers observed that in uninfected adipocytes, the hormone irisin altered the expression of genes that regulate ACE-2, which encodes a protein to which the virus binds in order to invade human cells. Credit: Miriane de Oliveira A study conducted by researchers at São Paulo State University (UNESP) suggests that irisin, a hormone secreted from […].

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Bringing Health Influencers Into Your Brand

Intouch Solutions

Today, the voices of influencers are vital. They can be gatekeepers to their audiences and authenticators of brand messaging, serving as extended voices of a brand. So how can pharma work well with health influencers, and to do so with expert precision? Find out here! The post Bringing Health Influencers Into Your Brand appeared first on Intouch Solutions.

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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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Parylene photonics enable future optical biointerfaces

Scienmag

Carnegie Mellon’s Maysam Chamanzar has developed a new class of materials for optical biointerfaces Credit: Carnegie Mellon University College of Engineering Carnegie Mellon University’s Maysam Chamanzar and his team have invented an optical platform that will likely become the new standard in optical biointerfaces. He’s labeled this new field of optical technology “Parylene photonics,” demonstrated […].

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Locanabio’s RNA-Targeting Gene Therapy May Offer Durable Response for DM1 Patients

BioSpace

RNA-binding proteins are emerging as the next generation of molecular medicine.

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Global change ecologist leads NASA satellite study of rapid greening across Arctic tundra

Scienmag

International team of researchers finds the region has become greener as warmer air and soil temperatures lead to increased plant growth Credit: Logan Berner, Northern Arizona University As Arctic summers warm, Earth’s northern landscapes are changing. Using satellite images to track global tundra ecosystems over decades, a team of researchers finds the region has become […].

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Bristol Myers Squibb’s Opdivo shows benefit in oesophageal cancers

Pharma Times

Data presented at 2020 ESMO virtual congress

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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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NASA sees rebirth of Tropical Storm Paulette

Scienmag

Credit: Credit: NASA/NOAA/NRL Tropical Storm Paulette just reformed in the central North Atlantic Ocean today, Sept. 22. Using a NASA satellite rainfall product that incorporates data from satellites and observations, NASA estimated Paulette’s rainfall rates. Paulette was a hurricane whose eye passed directly over Bermuda, then weakened and became a post-tropical cyclone on Sept. 16 […].

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Biopharma Update on the Novel Coronavirus: September 23

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.

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New study reveals why flu can be devastating for pregnant women

Scienmag

Pre-clinical study suggests virus does not stay in the lungs but spreads throughout the mother’s body Credit: RMIT University New research helps explain why flu can lead to life-threatening complications during pregnancy, suggesting the virus does not stay in the lungs but spreads throughout the mother’s body. The pre-clinical study has overturned current scientific thinking […].

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Online Pharma Forecasting Training for Everyone Now Available

pharmaphorum

Online Pharma Forecasting Training for Individuals or Groups is Now Available. Pharmaceutical forecasting can be challenging particularly during this time. Recognised as the pharmaceutical forecasting experts, J+D Forecasting has created several online pharma forecasting courses. Following the success of J+D Forecasting’s face to face training , the content has been redesigned to make it suitable for an online audience.

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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.