Bio Pharma Dive
NOVEMBER 16, 2020
Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead.
BioPharma Reporter
NOVEMBER 16, 2020
Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial explores a 1-dose regimen).
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Bio Pharma Dive
NOVEMBER 16, 2020
Several effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely.
Pharma Times
NOVEMBER 16, 2020
It is hoped that the move will help to tackle the persistent symptoms – such as fatigue and brain fog – suffered by people who have developed the condition
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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
NOVEMBER 16, 2020
Careful selection of a partner CRO can deliver advantages and accelerate your drug development program.
BioPharma Reporter
NOVEMBER 16, 2020
Modernaâs mRNA COVID-19 vaccine candidate has reported vaccine efficacy of 94.5% in the first Phase 3 interim analysis, released this morning. "This is a pivotal moment," says Moderna's CEO.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
NOVEMBER 16, 2020
The funds will help expand the scale of SARS-CoV-2 virus sequencing in the hope of revealing new opportunities for intervention
BioSpace
NOVEMBER 16, 2020
Warren Buffett, one of America’s best-known investors, is backing multiple pharmaceutical companies developing therapies aimed at curbing the ongoing global COVID-19 pandemic.
NY Times
NOVEMBER 16, 2020
Moderna is the second company to report preliminary results from a large trial testing a vaccine. But there are still months to go before it will be widely available to the public.
Pharma Times
NOVEMBER 16, 2020
The recommendations include new treatments for cancer and intraocular pressure and prevention of uncomplicated flu.
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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
XTalks
NOVEMBER 16, 2020
Moderna announced today that its highly anticipated COVID-19 vaccine candidate appears to be 94.5 percent effective. This is according to preliminary trial data from the company’s ongoing study that involves 30,000 people in the US. The news comes shortly after Pfizer and BioNTech’s mega announcement last week of their COVID-19 vaccine having shown 90 percent efficacy in an ongoing large-scale Phase III trial.
pharmaphorum
NOVEMBER 16, 2020
The antidepressant fluvoxamine merits further investigation as a potential treatment for COVID-19 according to findings of a preliminary trial. Findings of the trial involving 152 outpatients showed fluvoxamine, a selective serotonin reuptake inhibitor and sigma-1 receptor stopped clinical deterioration compared with placebo. All the patients on the US-based trial had confirmed COVID-19 and were randomly assigned to receive either fluvoxamine or placebo, three times daily for 15 days.
BioSpace
NOVEMBER 16, 2020
Only about one in seven cancer patients today benefit from immunotherapy. OncoMyx aims to increase this number, using a new multi-armed, systemically administered and targeted oncolytic virus.
Scienmag
NOVEMBER 16, 2020
‘Survival of the fittest’ phenomenon is only part of the evolution equation Credit: David S. Goodsell and RCSB PDB Darwin’s theory of evolution should be expanded to include consideration of a DNA stability “energy code” – so-called “molecular Darwinism” – to further account for the long-term survival of species’ characteristics on Earth, according to Rutgers […].
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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
NOVEMBER 16, 2020
There are many examples of how biopharma is leveraging AI and forging partnerships with companies focused on AI for drug development and clinical trials. There have been a few recent AI-based partnerships as well.
Scienmag
NOVEMBER 16, 2020
Credit: Kim Ratliff, Production Coordinator, Augusta University In the hours and days after a traumatic brain injury, inflammation inside the brain can accelerate to the point that more brain damage occurs, says a scientist working to better understand the acceleration and whether interventions like cannabinoids can improve patient outcomes. While some TBI patients do well, […].
pharmaphorum
NOVEMBER 16, 2020
The US healthcare system’s focus on activity rather than value for money was behind the demise of Proteus Digital Health and its “digital pill”, which measured whether schizophrenia patients took their meds, according to the company’s former CEO. At the Frontiers Health conference Andrew Thompson spoke to pharmaphorum’s web editor Catherine Longworth about lessons that can be learned from the company’s troubled attempt to market the technology.
Scienmag
NOVEMBER 16, 2020
Researchers study the ability of democracies to react to global crisis The PPI measures public health government responses to COVID-19 at all levels of government throughout the world. The PPI measure considers the extent of COVID-19 policy responses in the following… view more BINGHAMTON, NY — Are our political institutions up for the task of […].
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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.
Pharma Times
NOVEMBER 16, 2020
Janssen will enrol participants in countries with high incidence of COVID-19, including the UK
Scienmag
NOVEMBER 16, 2020
Study gives insight to tusk evolution of the marine mammal Credit: Journal of Vertebrate Paleontology Millions of years ago, in the warm Pacific Ocean off the coast of Southern California, walrus species without tusks lived abundantly. But in a new study, Cal State Fullerton paleontologists have identified three new walrus species discovered in Orange County […].
BioSpace
NOVEMBER 16, 2020
The word “children” may come second in their name, but Seattle Children’s Hospital is proving they truly put children first.
Scienmag
NOVEMBER 16, 2020
iIt is increasingly clear how Nef manages to subvert human cells’ defense mechanisms, enabling HIV to replicate and bringing the symptoms of AIDS closer Credit: Estela A. Pereira & Luis L. P. da Silva / FMRP-USP The discovery of a potential “Achilles heel” in Nef, the protein that is crucial to HIV virulence and its […].
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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.
BioSpace
NOVEMBER 16, 2020
This morning, the pharma giant signaled it will fail to meet a deadline related to $9 per share Contingent Value Rights (CVR) tickets, essentially killing that payment.
Scienmag
NOVEMBER 16, 2020
Cincinnati Children’s team reports controlling the BCAP protein could slow overactive immune response in IBD, rheumatoid arthritis or accelerate response against tumors Credit: Cincinnati Children’s Managing the activity of the BCAP protein could help the body repair intestinal tissue from damage caused by inflammation, according to a new study led by experts at Cincinnati Children’s. […].
BioSpace
NOVEMBER 16, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 17, 2020.
Scienmag
NOVEMBER 16, 2020
Collaborative study indicates meadows hold promise to help control carbon released into the atmosphere Credit: Photo by C.C. Reed, University of Nevada, Reno. RENO, Nev. – Meadows in the Sierra Nevada mountains are critical components of watersheds. In addition to supplying water to over 25 million people in California and Nevada, meadows contain large quantities […].
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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.
pharmaphorum
NOVEMBER 16, 2020
A new post-hoc analysis from Novo Nordisk of their SUSTAIN 6 and PIONEER 6 studies into semaglutide is looking to help ‘individualise’ treatment for diabetes patients by better predicting their cardiovascular lifetime risk. We spoke to lead study investigator, Utrecht University’s Dr Jan Westerink, to find out how he sees the results being used in daily practice.
Scienmag
NOVEMBER 16, 2020
A $2 Million NIH grant will fund the longitudinal study of lesbian and bisexual women ages 14 to 30 Credit: University of Central Florida What protective factors reduce the likelihood lesbian and bisexual women will consider killing themselves? That’s the focus of a $2 million national study led by researches at the UCF College of […].
BioSpace
NOVEMBER 16, 2020
A Phase III trial of NurOwn® (MSC-NTF cells), BrainStorm Cell Therapeutics’ investigational therapy for amyotrophic lateral sclerosis, did not find a statistically significant difference between the therapy and placebo for improving scores on a revised ALS functional rating scale.
Scienmag
NOVEMBER 16, 2020
Osaka University-led research team discovers new enzyme, opening novel routes for producing a family of valuable chemicals with medical and food uses Credit: Osaka University Osaka, Japan – Many plants, including legumes, make naturally occurring chemicals called saponins. For example, the medicinal plant licorice produces the saponin glycyrrhizin, a potent natural sweetener that also has […].
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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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