BioSpace
NOVEMBER 8, 2020
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
Scienmag
NOVEMBER 8, 2020
Credit: WEHI, Australia The World Health Organisation (WHO) has designated Australian medical research institute WEHI as the WHO Collaborating Centre for Anaemia Detection and Control, in recognition of WEHI researchers’ expertise in combatting anaemia. The designation enlists WEHI researchers to advise the WHO on the best approaches to diagnose and treat anaemia, which is a […].
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BioSpace
NOVEMBER 8, 2020
President-elect Joe Biden hit the ground running this morning with the announcement of his transition team’s COVID-19 advisory board.
Scienmag
NOVEMBER 8, 2020
Credit: Martina Butorac/Chalmers University of Technology At high concentrations, reactive oxygen species – known as oxidants – are harmful to cells in all organisms and have been linked to ageing. But a study from Chalmers University of Technology, Sweden, has now shown that low levels of the oxidant hydrogen peroxide can stimulate an enzyme that […].
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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
BioSpace
NOVEMBER 8, 2020
Bioelectric medicine is coming into its own as a combination or stand-alone therapy for a growing cohort of conditions.
Scienmag
NOVEMBER 8, 2020
Credit: NASA/European Space Agency/Alfred Vidal-Madjar (Institut d’Astrophysique de Paris, CNRS) Fast facts: Planetary habitability, defined by a planet’s ability to sustain liquid water on its surface, is one of the most important concepts in exoplanet science. Exoplanets (planets that orbit stars outside of our solar system) are subject to space weather in the form of […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
NOVEMBER 8, 2020
Researchers ended a clinical trial of the drug early because the results were so convincing. The more effective drug would be given in six injections a year instead of as 365 daily pills.
BioSpace
NOVEMBER 8, 2020
Calliditas said Nefecon hit its primary endpoint by demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after nine months of treatment.
Scienmag
NOVEMBER 8, 2020
Credit: WFIRM WINSTON-SALEM, NC, NOVEMBER, 2020 — Wake Forest Institute for Regenerative Medicine scientists (WFIRM) have developed a method to bioprint a type of cartilage that could someday help restore knee function damaged by arthritis or injury. This cartilage, known as fibrocartilage, helps connect tendons or ligaments or bones and is primarily found in the […].
BioSpace
NOVEMBER 8, 2020
It was relatively quiet in terms of COVID-19-related clinical trials, but there was still quite a bit of news for trials involving other indications. Here’s a look.
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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
Scienmag
NOVEMBER 8, 2020
First randomized clinical trial demonstrating that Circulating Tumor Cell count may help personalize treatment choices Bologna, Italy and Huntingdon Valley, Pa. — Menarini Silicon Biosystems, the pioneer of liquid biopsy technology, today announced the publication of a research study providing support for the reliability of using circulating tumor cell (CTC) count to guide frontline therapy […].
BioSpace
NOVEMBER 8, 2020
Data from this study is expected to support U.S. authorization and approval for their vaccine.
JAMA Internal Medicine
NOVEMBER 8, 2020
This survey study uses prepandemic data to estimate how many adults at increased risk of severe COVID-19 held essential jobs and could not work at home or lived in households with such workers.
BioSpace
NOVEMBER 8, 2020
They caution that as more data is accumulated and analyzed, the efficacy percentage may shift. Nonetheless, it’s extremely promising and there were no serious safety signals.
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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.
JAMA Internal Medicine
NOVEMBER 8, 2020
This cohort study examines the association between nursing home crowding and COVID-19 cases and mortality in the first months of the COVID-19 epidemic in Ontario, Canada.
BioSpace
NOVEMBER 8, 2020
Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.
Scienmag
NOVEMBER 8, 2020
Credit: CHIME In pursuit of unraveling the mysteries of Fast Radio Bursts, a new telescope will bring engineers at West Virginia University one step closer to an explanation. Thanks to a $1.7 million National Science Foundation grant awarded to Kevin Bandura, assistant professor in the Lane Department of Computer Science and Electrical Engineering in the […].
BioSpace
NOVEMBER 8, 2020
The pre-specified interim data analysis indicated the drug hit the primary objective of superiority compared to the current standard of care for women.
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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 8, 2020
New book looks at intersection of data science & media studies, presenting concepts and methods for computational analysis of cultural data Credit: The MIT PRESS, 2020. A book at the intersection of data science and media studies, presenting concepts and methods for computational analysis of cultural data. How can we see a billion images? What […].
The Pharma Data
NOVEMBER 8, 2020
Nov. 9, 2020 11:59 UTC. CLEARWATER, Fla.–( BUSINESS WIRE )– Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion ® in the cosmetic surgery market and J-Plasma ® in the hospital surgical market, today announced that it has completed subject enrollment in a U.S.
Drug Channels
NOVEMBER 8, 2020
16th Annual Life Sciences Trade and Channel Strategies. December 1-3, 2020 | Virtual Event www.informaconnect.com/trade-channel. Navigating the distribution and contracting landscape is a complex endeavor. That’s why the life science industry’s top experts will come together virtually on December 1-3 at Trade and Channel 2020. They’ll guide you through new and innovative ways to optimize channel strategies to reach patients in need and provide the necessary services based on product type, site o
The Pharma Data
NOVEMBER 8, 2020
November is promising to be a busy month for the U.S. Food and Drug Administration (FDA) in terms of PDUFA dates. Here’s a look at some of the upcoming target action dates on the FDA’s calendar. . Supernus Pharmaceuticals’ SPN-812 for ADHD. Supernus Pharmaceuticals has a target action date of November 8, 2020 for SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD).
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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.
Drug Patent Watch
NOVEMBER 8, 2020
Annual Drug Patent Expirations for PALLADONE Palladone is a drug marketed by Purdue Pharma Lp and is included in one NDA. There is one patent protecting this drug. Drug patent…. The post New patent expiration for Purdue Pharma drug PALLADONE appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
NOVEMBER 8, 2020
T hird generation of the family to take on a more significant role within the Board of Directors. Nomination of Carlos Gallardo demonstrates commitment of the family to Almirall’s future. BARCELONA, Spain , Nov. 9, 2020 /PRNewswire/ — Almirall, S.A. (ALM) the global biopharmaceutical company based in Barcelona , has announced the nomination of Carlos Gallardo as Vice President of the Board of Directors effective immediately.
Drug Patent Watch
NOVEMBER 8, 2020
Annual Drug Patent Expirations for DILAUDID-HP Dilaudid-hp is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from one supplier. There are three…. The post New patent expiration for Fresenius Kabi drug DILAUDID-HP appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
NOVEMBER 8, 2020
LONDON and RALEIGH, N.C., Nov. 09, 2020 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces that David Zaccardelli, Chief Executive Officer and President, will present a company overview at the following virtual investor conferences in November 2020: Stifel 2020 Virtual Healthcare Conference Date: Monday, November 16 Time: 4:00 PM ET / 9:00 PM GMT.
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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.
Drug Patent Watch
NOVEMBER 8, 2020
Annual Drug Patent Expirations for AXUMIN Axumin is a drug marketed by Blue Earth and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent expiration for Blue Earth drug AXUMIN appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
NOVEMBER 8, 2020
Humanigen on Friday revealed positive interim data in a late-stage clinical trial of its monoclonal antibody lenzilumab for the treatment of COVID-19 patients, but a trial design expert contended that the disclosure was inappropriate and could put the trial’s integrity at risk. Source link.
Drug Patent Watch
NOVEMBER 8, 2020
Annual Drug Patent Expirations for DILAUDID Dilaudid is a drug marketed by Fresenius Kabi Usa and Rhodes Pharms and is included in three NDAs. It is available from three suppliers.…. The post New patent expiration for Rhodes Pharms drug DILAUDID appeared first on DrugPatentWatch - Make Better Decisions.
NY Times
NOVEMBER 8, 2020
Recent studies have created doubts about an agent in cytokine storms, and suggest that treatments for it may not help.
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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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