Bio Pharma Dive
SEPTEMBER 29, 2020
On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.
Pharma Mirror
SEPTEMBER 29, 2020
Ahead of the CPhI Festival of Pharma (5-16 October, 2020) – global pharma’s largest ever virtual gathering – the CPhI Pharma Index shows only Italy and India have improved their score in 2020, with the majority of industry executives looking for new supply chain partners. The Index – an aggregated confidence score across the five. The post Italy and India the only pharma economies to improve score in 2020 according to the CPhI Pharma Index appeared first on Pharma Mirror Magazine.
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Bio Pharma Dive
SEPTEMBER 29, 2020
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.
pharmaphorum
SEPTEMBER 29, 2020
The pharmaceutical industry is one of the most scientifically innovative and competitive industries, particularly in oncology. As of 2018, there were over 1,100 cancer therapies in development, and as of 2020, 362 of them were cell and gene therapies. As a result, there is a need for continued innovation and increased efficiency in terms of drug development to manage cost, complexity and speed to provide potentially transformative therapies for cancer patients.
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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
SEPTEMBER 29, 2020
Preliminary study data suggest the treatment could help people whose bodies aren't already fighting off infection, a finding the biotech is discussing with regulators.
pharmaphorum
SEPTEMBER 29, 2020
UK Prime Minister Boris Johnson has told the UN General Assembly that the UK will donate £571 million ($735 million) to the COVAX scheme aimed at distributing COVID-19 vaccines fairly around the world. The lion’s share of that total – around £500 million – will be “for developing countries to protect themselves,” said the PM in a recorded speech given to the assembly, delivered just before the number of deaths due to coronavirus topped 1 million worldwide.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 29, 2020
Pfizer invested $200 million into the company for a nearly 10% stake to support the development of a checkpoint inhibitor aimed at the oncology market in China.
Bio Pharma Dive
SEPTEMBER 29, 2020
Former heads of BARDA and NESTcc highlighted a need for comparing test types and protocols as the U.S. seeks to boost point-of-care options for asymptomatic and pre-symptomatic people.
BioSpace
SEPTEMBER 29, 2020
Moderna published second interim analysis of its open-label Phase I trial of its COVID-19 vaccine, mRNA-1273, in The New England Journal of Medicine.
Bio Pharma Dive
SEPTEMBER 29, 2020
The company will halt further work on its only fully owned drug and focus instead on expanding sales of its marketed product Linzess.
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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
SEPTEMBER 29, 2020
Draper, in one of the latest lab-on-a-chip advances, has shown that its dynamic, in vitro tumor microenvironment can be used to distinguish tumor responses against two different checkpoint inhibitors in three mouse lines.
pharmaphorum
SEPTEMBER 29, 2020
The FDA has fast tracked development of AbbVie’s potential spinal injury drug, elezanumab, a process that will be aided by digital analysis. The regulator has also granted it orphan status, which cuts development costs and potentially boosts profits if approved. Elezanumab is a monoclonal antibody that binds selectively to repulsive guidance molecule, which is known to inhibit regeneration of neurons and functional recovery following central nervous system damage.
BioSpace
SEPTEMBER 29, 2020
The Serum Institute of India (SII) has agreed to produce and deliver up to an additional 100 million doses of an approved COVID-19 vaccine for citizens of India and neighboring low- and middle-income countries as part of a collaboration with Gavi and the Bill & Melinda Gates Foundation.
JAMA Internal Medicine
SEPTEMBER 29, 2020
This randomized clinical trial evaluates the efficacy of hydroxychloroquine to prevent transmission of SARS-CoV-2 in health care workers with exposure to patients with COVID-19 at 2 hospitals in Philadelphia, Pennsylvania.
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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
SEPTEMBER 29, 2020
Credit: TU Delft Researchers from TU Delft have now developed a new model that describes driving behaviour on the basis of one underlying ‘human’ principle: managing the risk below a threshold level. This model can accurately predict human behaviour during a wide range of driving tasks. In time, the model could be used in intelligent […].
Forte Research Systems®
SEPTEMBER 29, 2020
Integrated research solutions are beneficial to cancer centers in more ways than one — institutions can leverage technology, services, and IRB/IBC to streamline research.
Scienmag
SEPTEMBER 29, 2020
Hebrew University researchers inch closer to harnessing DNA molecules for disease detection and electronics Credit: Hebrew University We know that DNA molecules express heredity through genetic information. However, in the past few years, scientists have discovered that DNA can conduct electrical currents. This makes it an interesting candidate for roles that nature did not intend […].
Pharma Times
SEPTEMBER 29, 2020
First phase will see company deploy 300 PCR instruments to the UK
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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
SEPTEMBER 29, 2020
Credit: McMaster University HAMILTON, ON, Sept. 29, 2020 — An international team led by current and former McMaster University researchers has developed an artificial lung to support pre-term and other newborn babies in respiratory distress. The group has proven the concept using a live piglet, a major step along the route toward approval for use […].
BioSpace
SEPTEMBER 29, 2020
The special purpose acquisition company, which has listed the units and is beginning to trade on the Nasdaq Capital Market, expects the proposed deal to command a market value of close to $500 million.
Scienmag
SEPTEMBER 29, 2020
Credit: Lawson Health Research Institute LONDON, ONTARIO – A new study from Lawson Health Research Institute and Western University illustrates how the gut microbiome interacts with an oral medication in prostate cancer patients, suggesting bacteria in the gut play a role in treatment outcomes. The findings, published in Nature Communications, highlight how the drug abiraterone […].
Pharma Times
SEPTEMBER 29, 2020
First subject dosed with new drug candidate from strategic collaboration
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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
SEPTEMBER 29, 2020
Credit: Photo courtesy of Alexander Kirdyanov Madison, WI, September 29, 2020 – An international team of scientists that includes a USDA Forest Servicescientist based in New Hampshire used tree rings to document how “Arctic dimming,” the interference with sunlight caused by extreme pollution such as that at an industrial complex in northern Siberia, is killing […].
BioSpace
SEPTEMBER 29, 2020
Although still preliminary, Regeneron Pharmaceuticals announced early data from its Phase I/II/III trial of its antibody cocktail, REGN-COV2, against COVID-19.
BioPharma Reporter
SEPTEMBER 29, 2020
The companyâs studies exploring the use of opaganib in severe COVID-19 patients have been approved in Brazil and other countries around the globe.
Pharma Times
SEPTEMBER 29, 2020
Treatment becomes first and only biologic for HES in the US
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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.
Scienmag
SEPTEMBER 29, 2020
Clues sought for why 1 in 5 pediatric cancer survivors develop heart failure Credit: UT Health San Antonio Cancer chemotherapy changes the function of cells that repair heart injury, researchers at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) discovered. Twenty percent of children treated with drugs called anthracyclines […].
BioSpace
SEPTEMBER 29, 2020
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
Scienmag
SEPTEMBER 29, 2020
Credit: West Virginia University A three-year collaborative project to develop a new low-cost process to convert the natural gas that is commonly flared at industrial sites could benefit a number of industrial sectors including the carbon fiber industry, carbon composite, electronics, electrical arc steel making, polymer additives and many others, all while having a positive […].
Pharma Times
SEPTEMBER 29, 2020
Treatment is being developed by Australian biotech Ena Respiratory
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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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