Bio Pharma Dive
OCTOBER 22, 2020
The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness.
World of DTC Marketing
OCTOBER 22, 2020
As people move up the pharma ladder, their work often revolves around internal management issues, training, and endless meetings to motivate their employees rather than focus on patients. Pharma likes to believe its own propaganda that everything they do is patient-focused, but that’s a canard. Pharma’s own internal processes and endless meetings are slowly draining the life out of employees and lead to a culture where people are promoted to navigate the system rather than help peopl
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Bio Pharma Dive
OCTOBER 22, 2020
A deal with Atea Pharmaceuticals gives Roche rights to an oral antiviral for coronavirus disease that would compete with emerging therapies from Pfizer and Merck.
Pharma Mirror
OCTOBER 22, 2020
By Rotem Shor, Medisafe Chief Technology Officer Technology and health have experienced a convergence in the last few years, leading to a new state of digital health that is transforming how we live and work. But there is a greater science behind it that analyzes tremendous amounts of data to shape and personalize our health. The post Using Behavioral Science in A Digital World appeared first on Pharma Mirror Magazine.
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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
Bio Pharma Dive
OCTOBER 22, 2020
The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million.
BioSpace
OCTOBER 22, 2020
Researchers with Pfizer and IBM developed an artificial intelligence (AI) model that they claim can predict eventual onset of Alzheimer’s disease with 71% accuracy based on a language sample. They published the research today in The Lancet eClinicalMedicine.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 22, 2020
Cancer doesn’t end when treatment stops – it’s a lifelong journey and people need support throughout, says patient advocate Megan-Claire Chase. No one gets through cancer unscathed. People are usually left with a mixture of treatment aftereffects, toxic positivity, and lingering anger to deal with. Megan-Claire Chase , a fierce patient advocate who has been blogging about her experiences since she was diagnosed with breast cancer in 2015, said the disease never went away.
Bio Pharma Dive
OCTOBER 22, 2020
Recruiting 30,000 participants for the late-stage trial took Moderna just three months, even after the company slowed enrollment to boost participation of people of color.
BioSpace
OCTOBER 22, 2020
Moderna has fully enrolled its late-stage coronavirus disease 2019 (COVID-19) vaccine trial by hitting its target of 30,000 participants. More than one-third of this cohort includes minority participants.
Bio Pharma Dive
OCTOBER 22, 2020
The New Jersey facility that ran afoul of FDA manufacturing standards is one of several Lilly is using to produce coronavirus antibody drugs.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
BioSpace
OCTOBER 22, 2020
The new fund, RA Capital Nexus Fund II, will serve as a companion fund to RA’s Nexus I fund, which closed last year with approximately $300 million in capital.
BioPharma Reporter
OCTOBER 22, 2020
The use of CRISPR, the genetic scissors that allow scientists to edit the instruction manual of life, DNA, has drawn massive global attention over the last several years.
BioSpace
OCTOBER 22, 2020
Shares of Gilead Sciences are jumping in aftermarket trading following full approval for Veklury (remdesivir) as a treatment for COVID-19. The approval marks the first drug approved by the U.S. Food and Drug Administration as a treatment for the novel coronavirus.
BioPharma Reporter
OCTOBER 22, 2020
Current COVID-19 vaccine Phase 3 trials are not designed to show whether they will save lives or reduce transmission: with trials instead based on events with mild symptoms, according to a feature published in The BMJ.
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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.
BioSpace
OCTOBER 22, 2020
Roche and Atea Pharmaceuticals are partnering to develop, manufacture and distribute AT-527, Atea’s experimental antiviral drug against COVID-19.
pharmaphorum
OCTOBER 22, 2020
Sarepta chief commercial officer Bo Cumbo has left to head up gene therapy venture – AavantiBio – with $107 million in backing from his former employer and three high-profile life sciences investors. Rare disease specialist Sarepta is putting up $15 million of that first-round financing, with the remainder coming from Perceptive Advisors, Bain Capital Life Sciences, and RA Capital Management.
BioSpace
OCTOBER 22, 2020
October is Breast Cancer Awareness month, and Daiichi Sankyo is aiming to raise awareness about one of the most common forms of cancer across the globe.
BioPharma Reporter
OCTOBER 22, 2020
Scientists have used gene therapy and a newly developed light-sensing protein to restore sight in mice: with the technology to start clinical trials in the US later this year.
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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.
BioSpace
OCTOBER 22, 2020
Many drug makers are investing in new science and hope to transition pain therapy approaches away from synthetic opioids. Biospace has tracked a few key alternative therapeutic candidates.
XTalks
OCTOBER 22, 2020
Pharmaceutical development of novel drugs is a complex and tedious process. The information shared between different multidisciplinary teams is critical to reducing the cost and ultimately accelerating the path of bringing a drug to market. To achieve transparency and actionability of data, pharmaceutical companies are evolving their manufacturing processes by digitalizing the data from all of their equipment.
BioSpace
OCTOBER 22, 2020
The findings from this study were presented at the virtual American Society of Nephrology’s (ASN) Kidney Week 2020 on October 23, and the full study was published in a recent online edition of the New England Journal of Medicine.
Scienmag
OCTOBER 22, 2020
Credit: U.S. Army Operational Test Command photo/Tad Browning WEST LAFAYETTE, Ind. — Drones and other unmanned machines can save human lives on the battlefield, but adversaries could hack into their artificial intelligence software. Purdue University will be leading research in partnership with Princeton University on ways to protect the software of these autonomous systems by […].
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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.
BioPharma Reporter
OCTOBER 22, 2020
Diagnostics company Oxford Immunotec Global PLC has been selected to provide T cell testing to the UK Vaccines Taskforce.
XTalks
OCTOBER 22, 2020
The UK will be the first country to initiate a COVID-19 human challenge trial in which healthy people will be deliberately exposed to the SARS-CoV-2 virus, as announced on October 20 th. The UK government and a Dublin-based commercial clinical research organization called Open Orphan and its subsidiary, hVIVO, will lead the COVID-19 challenge study.
BioSpace
OCTOBER 22, 2020
Bolstered by studies in rodents, iota Biosciences advances towards their vision.
Drug Patent Watch
OCTOBER 22, 2020
Annual Drug Patent Expirations for UPNEEQ Upneeq is a drug marketed by Rvl Pharms and is included in one NDA. There are two patents protecting this drug. This drug has…. The post New patent for Rvl Pharms drug UPNEEQ appeared first on DrugPatentWatch - Make Better Decisions.
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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.
BioSpace
OCTOBER 22, 2020
After reviewing its mid-pandemic performance, it became clear that its greatest challenge is around the handling of data, according to Amy P. Abernethy, M.D., Ph.D., principal deputy commissioner, FDA, speaking at the recent Demy-Colton Virtual Salon, the “Fusion of Technologies.
Drug Patent Watch
OCTOBER 22, 2020
Annual Drug Patent Expirations for POMALYST Pomalyst is a drug marketed by Celgene and is included in one NDA. It is available from one supplier. There are eleven patents protecting…. The post New patent expiration for Celgene drug POMALYST appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
OCTOBER 22, 2020
Two Phase III studies showed significant reduction in urinary oxalate excretion in patients of all ages with PH1.
XTalks
OCTOBER 22, 2020
With heavy competition and the onset of COVID-19, building a successful food company is becoming more and more difficult. But a new report from the New York-based firm Lux Research outlines six underlying trends that are shaping the food and beverage industry – and what food companies can do now to maintain success over the next 30 years. The report, entitled “ The Food Company of 2050 ,” points to several reasons why being a food company in 2020 is becoming increasingly difficult.
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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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