Bio Pharma Dive
NOVEMBER 9, 2020
The Food and Drug Administration cleared the company's synthetic antibody treatment, but short supplies and logistical challenges could limit its initial impact.
World of DTC Marketing
NOVEMBER 9, 2020
SUMMARY: Patient influencers trust social media groups more than pharma websites for health information, according to a survey from Wego Health. Imagine a survey like this from a company that specializes in patient influencers. Over the years, I am very proud to say that I’ve been involved in a LOT of qual and quant research. I’ve seen that, while people will turn to social media for health information, they seldom make treatment decisions based on what they find.
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Bio Pharma Dive
NOVEMBER 9, 2020
An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective.
The Pharma Data
NOVEMBER 9, 2020
DAEGU, KOREA, November 09, 2020 /24-7PressRelease/ — South Korean religious group Shincheonji Church of Jesus has announced their third convalescent plasma donation drive to take place for 3 weeks starting November 16th at an Indoor Athletics Center in Daegu. Approximately 4,000 members of the group are expected to participate. This comes after two previous donation drives that took place in July and September.
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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 9, 2020
The decidedly negative vote at Friday's meeting on aducanumab raises questions about the drug's future, as well as the credibility of the FDA.
BioPharma Reporter
NOVEMBER 9, 2020
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 9, 2020
Bamlanivimab, an intravenous treatment, should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.
BioPharma Reporter
NOVEMBER 9, 2020
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. âToday is a great day for science and humanity,â says the companyâs CEO.
XTalks
NOVEMBER 9, 2020
SARS-CoV-2 Vaccines Inch Towards Regulatory Approval. Over the past month or so, investigators have been amassing data on SARS-CoV-2 candidate vaccines as quickly as possible and some of that data is making its way—ever so much more slowly—through regulatory agencies for official scrutiny. Quite possibly the fastest data review will be for AstraZeneca’s/University of Oxford AZD1222 vaccine in Britain , where the Medicines and Healthcare Products Regulatory Agency is now conducting a “rolling rev
pharmaphorum
NOVEMBER 9, 2020
There isn’t enough evidence to suggest that digital therapies for people with opioid use disorder (OUD) can improve on standard interventions, according to the Institute for Clinical and Economic Review. The US cost-effectiveness watchdog has concluded in an evidence report that none of three digital therapies under scrutiny – apps from Pear Therapeutics, Chess Health and DynamiCare Health – have data from a randomised clinical trial showing they can enhance long-term abstinence or retention rat
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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
NOVEMBER 9, 2020
It isn’t often that a contestant pulls ahead in a major contest and their competitor wins too, but Moderna – along with other COVID-19 vaccine contenders – will take it.
pharmaphorum
NOVEMBER 9, 2020
The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved to be a fractious affair, with both the companies’ data – and some of the FDA’s interpretation of it – under fire by panellists.
Scienmag
NOVEMBER 9, 2020
Credit: Kennedy et al, 2020 (PLOS Biology, CC BY 4.0) UNIVERSITY PARK, Pa. — Similar to bacteria evolving resistance to antibiotics, viruses can evolve resistance to vaccines, and the evolution of SARS-CoV-2 could undermine the effectiveness of vaccines that are currently under development, according to a paper published November 9 in the open-access journal PLOS […].
pharmaphorum
NOVEMBER 9, 2020
As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis. The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements.
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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.
Scienmag
NOVEMBER 9, 2020
Credit: AlphaMed Press Durham, NC – A new study released today in STEM CELLS might just have solved the mystery behind why mesenchymal stem cells (MSCs) continue to suppress inflammation in the body long after the MSCs are cleared from the system. The findings, by researchers at Duke University (Durham, N.C.), could help overcome a […].
Pharma Times
NOVEMBER 9, 2020
Phase III study of vaccine candidate involved 43,538 participants
Scienmag
NOVEMBER 9, 2020
Credit: University of Otago Research has confirmed the nationwide Alert Level 4 COVID-19 lockdown had a significant toll on New Zealanders’ well-being, especially for younger people – but the results were not all negative. Researchers from the University of Otago conducted a demographically representative survey of adult New Zealanders between 15 and 18 April, corresponding […].
BioSpace
NOVEMBER 9, 2020
Several states have pledged to review COVID-19 vaccines themselves, after FDA emergency use authorizations, to ensure safety and efficacy. A robust review, however, is unlikely.
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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.
Scienmag
NOVEMBER 9, 2020
A new approach to modifying microbes’ metabolic processes will speed up production of innovative bio-based fuels, materials, and chemicals Credit: Berkeley Lab Researchers from Lawrence Berkeley National Laboratory (Berkeley Lab) have achieved unprecedented success in modifying a microbe to efficiently produce a compound of interest using a computational model and CRISPR-based gene editing.
BioSpace
NOVEMBER 9, 2020
The interim analysis demonstrated that two doses of the vaccine ranging from 2 micrograms to 12 micrograms per dose, given 28 days apart, were safe, with no vaccine-related serious adverse events.
Scienmag
NOVEMBER 9, 2020
Credit: University of Ottawa Researchers from the University of Ottawa and The Ottawa Hospital have been awarded $1,050,000 million from the Canada Foundation for Innovation to support facilities for manufacturing innovative treatments and vaccines for COVID-19. The funding will support new equipment and infrastructure at The Ottawa Hospital’s Biotherapeutics Manufacturing Centre (BMC), which has been […].
BioSpace
NOVEMBER 9, 2020
Clinical-stage gene therapy company Axovant Gene Therapies is changing its name to Sio Gene Therapies, a move that will likely further distance the company from disappointing results of its Alzheimer’s candidate just three years ago.
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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.
Scienmag
NOVEMBER 9, 2020
U.S. government expands utilization of Adranos’ high-performance solid rocket fuel Credit: Chris Stoker/Adranos WEST LAFAYETTE, Ind. – Adranos Inc., a Purdue University-affiliated company that develops a high-performance, solid-rocket fuel called ALITEC for long-range missile and space launch systems, has obtained $2.1 million in funds from the U.S.
BioPharma Reporter
NOVEMBER 9, 2020
President-elect Joe Biden has launched a Transition COVID-19 Advisory Board to support the USâ COVID-19 response.
Scienmag
NOVEMBER 9, 2020
Credit: (Photo/iStock) As the holiday season nears, thoughts of pumpkin pies, roasted chestnuts and turkey dinners fill our dreams and our grocery shopping lists. While visions of holiday food may be pleasing to the eyes and tantalizing to the palate, it would be a mistake to conclude that pretty food is healthier than other food. […].
XTalks
NOVEMBER 9, 2020
NotMilk is a new plant-based milk alternative made by Latin American food technology company, NotCo, and is now launching in the US. The company uses artificial intelligence and machine learning algorithms that help mimic animal-based foods using plant-based ingredients. The milk alternative is designed to provide consumers with the same taste and texture that replicates dairy-based milk.
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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 9, 2020
COVID-19 has sparked a flurry of research and discoveries are being made at an unprecedented rate – but patient participation cannot and should not be left behind in the rush, say leading voices. SARS-CoV-2 has demonstrated both the strengths and the weaknesses of the life sciences ecosystem, and it is now up to the sector to learn and to lead. While trials of COVID-19 vaccines and treatments have accelerated at a hitherto unimaginable rate, work in other conditions has been halted and paused, b
Pharma Times
NOVEMBER 9, 2020
Industry bodies respond to Specialised Committee outcome
BioTech 365
NOVEMBER 9, 2020
Concert Pharmaceuticals to Present at Upcoming Investor Conferences Concert Pharmaceuticals to Present at Upcoming Investor Conferences LEXINGTON, Mass.–(BUSINESS WIRE)–$CNCE #CNCE—Concert Pharmaceuticals, Inc.
Pharma Times
NOVEMBER 9, 2020
Approval is based on results from phase III THALES trial
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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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