8 key clinical trials to watch for the rest of 2021
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.
Bio Pharma Dive
JUNE 21, 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy.
pharmaphorum
JUNE 21, 2021
It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.
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Bio Pharma Dive
JUNE 21, 2021
Final clinical trial results confirmed treatment dramatically reduced the risk of hospitalization and death among adults with mild-to-moderate COVID-19.
BioSpace
JUNE 21, 2021
Use of the anti-parasitic drug ivermectin could reduce COVID-19 related deaths, data from a peer-reviewed study shows.
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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
JUNE 21, 2021
With more and more states screening for SMA at birth, the study results are important for assessing Zolgensma's benefits when given very early on.
JAMA Internal Medicine
JUNE 21, 2021
This cross-sectional study uses administrative health care data on 2.9 million households from the first 45 weeks of 2020 to assess the association between social gatherings and SARS-CoV-2 transmission by studying whether COVID-19 rates increase after birthdays in a household.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 21, 2021
Children treated with gene therapy prior to symptom presentation achieved motor milestones not seen in the natural history of SMA
Bio Pharma Dive
JUNE 21, 2021
A closer look at the impact of automated and digitalized technologies on the industrial microbiology workflow.
XTalks
JUNE 21, 2021
In a new study, Amazon’s Halo app has been shown to predict body fat percentage with the same level of accuracy as standard lab testing. The app uses just four photos taken from a smartphone — of the front, back and each side of the body — to build a 3D model and produce body fat percentage results using the app’s built-in machine learning algorithms.
Pharma Times
JUNE 21, 2021
Aubagio has been authorised for the treatment of paediatric patients aged ten to 17 years living with RRMS
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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
JUNE 21, 2021
Recent research shows those who had been hospitalized due to COVID-19 might already have a reduced sense of smell and taste, not just for the short term, but possibly for life.
Scienmag
JUNE 21, 2021
The impact of super-spreader cities, highways, and intensive care availability in the early stages of the COVID-19 epidemic in Brazil Credit: Nicolelis, M.A.L. et al. 2021. Scientific Reports, doi.org/10.1038/s41598-021-92263-3 São Paulo, Brazil – A multidisciplinary analysis by a group of Brazilian scientists, published online in the journal Scientific Reports on June 21, 2021, revealed that […].
pharmaphorum
JUNE 21, 2021
Sanofi’s Aubagio has become the first oral therapy approved for first-line use in children and adolescents with multiple sclerosis in the EU, a few days after the same indication was turned down by the FDA in the US. The results of the phase 3 TERIKIDS trial were deemed adequate to get a green light from the European Commission, but were rejected as inadequate last week by the FDA, which has asked Sanofi to carry out another trial in paediatric MS.
Scienmag
JUNE 21, 2021
Scientists find a way to efficiently use visible light from the sun to break down CO2, open doors to novel means of alleviating global warming Credit: Image courtesy: Shinji Kawasaki and Yosuke Ishii from Nagoya Institute of Technology Carbon dioxide (CO2) emissions from human activities have risen drastically over the last century and a half […].
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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
JUNE 21, 2021
GSK CEO Emma Walmsley may face some contentious opposition from key investors interested in forcing a management change following the planned investor update.
pharmaphorum
JUNE 21, 2021
The NHS App has soared in popularity since it was updated in May to allow people to record their COVID-19 vaccination status, with more than 2 million new signups taking the total number of users to 6 million. . The app – which should not be confused with the NHS COVID-19 track and trace app – was used by five million people in the last month, according to the Department of Health and Social Care.
Scienmag
JUNE 21, 2021
A new human organoid developed by Gladstone scientists mimics one of the key steps in early embryonic development Credit: Photo: Michael Short/Gladstone Institutes SAN FRANCISCO, CA–June 21, 2021–The progression from a round ball of cells to an embryo with a head and a tail is one of the most critical steps in an organism’s development. […].
BioSpace
JUNE 21, 2021
Roche presented results from several Phase II and III trials at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting held virtually June 19-22.
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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
JUNE 21, 2021
Approval makes Astepro the first and only OTC steroid free antihistamine nasal spray available in the US
Scienmag
JUNE 21, 2021
Credit: Professor Anna Klinkova of the University of Waterloo New research is showing that some tiny catalysts being considered for industrial-scaled environmental remediation efforts may be unstable during operation. Chemists from the University of Waterloo studied the structures of complex catalysts known as “nanoscale electrocatalysts” and found that they are not as stable as scientists […].
BioSpace
JUNE 21, 2021
The new U.S. HQ for Neogene has the backing of biotech guru Arie Belldegrun, CEO of Kite Pharma. The company has leased 38,000 sq. ft. in two Santa Monica buildings.
Scienmag
JUNE 21, 2021
Combining atomic-scale sample analysis and models simulating likely conditions in the nascent solar system, the study revealed clues about the origin of crystals that formed more than 4.5 billion years ago Credit: Heather Roper A research team led by the University of Arizona has reconstructed in unprecedented detail the history of a dust grain that […].
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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
JUNE 21, 2021
The U.S. CDC issued new guidance for long COVID, and the NIH is figuring out how to deal with the disease, while Tonix Pharma plans to develop TNX-102 SL.
Scienmag
JUNE 21, 2021
Credit: Unsplash It’s been named the world’s best diet for weight loss, but now researchers at the University of South Australia are confident that the Mediterranean Diet – combined with a daily bout of exercise – can also stave off dementia, slowing the decline in brain function that is commonly associated with older age. In […].
XTalks
JUNE 21, 2021
In June 2021, I held a webinar on modular real-time monitoring in the pharmaceutical cold chain together with Berlinger’s Head of Research & Development Bernd Heisterkamp and CEO Thomas Bechter. In the following, I summarize the key messages from the webinar, share our learnings from the audience and take you behind the scenes into technology that’s currently under development.
Scienmag
JUNE 21, 2021
A tiny device incorporates a compound made from starch and baking soda to harvest energy from movement Credit: dgist Scientists have used a compound made from a starch derivative and baking soda to help convert mechanical to electrical energy. The approach, developed by scientists at Daegu Gyeongbuk Institute of Technology (DGIST), with colleagues in Korea […].
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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
JUNE 21, 2021
The business combination agreement will advance SAB’s proprietary platform to develop antibody therapies for immune system disorders and other diseases.
Scienmag
JUNE 21, 2021
Credit: The University of Hong Kong A research team led by Professor Hongzhe SUN, Norman & Cecilia Yip Professor in Bioinorganic Chemistry and Chair Professor from Research Divison for Chemistry and Department of Chemistry, Faculty of Science, in collaboration with Dr Richard Yi-Ysun KAO, Associate Professor from the Department of Microbiology, Li Ka Shing Faculty […].
BioSpace
JUNE 21, 2021
Spruce Biosciences shared results from two Phase II studies assessing tildacerfont, a non-steroidal, oral antagonist for the treatment of adult patients with classic CAH.
Scienmag
JUNE 21, 2021
Researchers have shown why people with mental health disorders, including anorexia and panic disorders, experience physical signals differently. The researchers, from the University of Cambridge, found that the part of the brain which interprets physical signals from the body behaves differently in people with a range of mental health disorders, suggesting that it could be […].
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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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