Bio Pharma Dive
JULY 6, 2021
The results are a potentially significant finding that could help change how heart failure patients with preserved ejection fraction are treated, and will support the companies' application for the drug's approval.
pharmaphorum
JULY 6, 2021
The UK’s biotechnology sector is going through a purple patch, attracting almost £1.6 billion ($2.2 billion) in financing in the three months to end-May – which is a record for the industry. The new figures – from the BioIndustry Association and Clarivate – were dominated by more than £1 billion in venture capital funding for UK biotech and life sciences companies, headlined by DNA sequencing company Oxford Nanopore’s £195 million raise in May that was just shy of the £205 million re
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Bio Pharma Dive
JULY 6, 2021
The biotech's decision to pause testing of a cystic fibrosis drug is the latest reminder of the difficulty of delivering RNA medicines into the lungs.
Pharma Times
JULY 6, 2021
Vaccine will be evaluated in 13 HIV-negative adults aged 18-65 years old
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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
JULY 6, 2021
Provention Bio said it expects to collect data that could address the FDA's concerns before the end of September. In the meantime, though, the company's shares have taken another hit.
pharmaphorum
JULY 6, 2021
A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response or better, compared to 29% of patients given only chemo.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 6, 2021
Novartis has tried to get its marketing application for high cholesterol therapy inclisiran in the US back on track, after the FDA rejected it last year, by changing the factory that makes the drug. The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.
BioSpace
JULY 6, 2021
The long weekend didn't slow down the IPO train barreling down the tracks. More life sciences companies announced and closed their initial public offerings, bringing millions more to their coffers.
Scienmag
JULY 6, 2021
Credit: University of Huddersfield A new report that could help improve how immersive technologies such as Virtual Reality (VR) and Augmented Reality (AR) are used in healthcare education and training has been published with significant input from the University of Huddersfield. Professor David Peebles, Director of the University’s Centre for Cognition and Neuroscience, and Huddersfield […].
BioSpace
JULY 6, 2021
Following a manufacturing mistake that left Emergent BioSolutions with a botched batch of Johnson & Johnson’s COVID-19 vaccine, Emergent is now facing a shareholder lawsuit accusing the company of insider trading.
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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
JULY 6, 2021
Studies reveal unprecedented mechanism behind loss of antibody neutralization against this pandemic coronavirus variant of concern Credit: Young-Jun Park, UW Department of Biochemistry Three mutations in the Epsilon coronavirus spike protein dampen the neutralizing potency of antibodies induced by current vaccines or past COVID infections. The mutations give this coronavirus variant of concern a means […].
BioSpace
JULY 6, 2021
The WHO is calling for manufacturers to cut prices and increase the availability of supplies to low- and middle-income nations to parts of the world where COVID-19 continues to surge.
Scienmag
JULY 6, 2021
Credit: LI Nian Recently, Prof. WANG Zhenyang’s research group from the Hefei Institutes of Physical Science (HFIPS) of the Chinese Academy of Sciences (CAS) has prepared macroscopic thick three-dimensional (3D) porous graphene films. Using high-energy electron beam as the energy source and taking advantages of high kinetic energy and low reflection characteristics of e-beam, the […].
BioPharma Reporter
JULY 6, 2021
Eli Lilly and Company will make an equity investment of around $15m in MiNA Therapeutics: a company with a proprietary small activating RNA (saRNA) technology platform.
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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
JULY 6, 2021
GRACE: Guidelines for reasonable and appropriate care in the emergency department Credit: KIRSTY CHALLEN, B.SC., MBCHB, MRES, PH.D., LANCASHIRE TEACHING HOSPITALS, UNITED KINGDOM Des Plaines, IL – The Society for Academic Emergency Medicine (SAEM) is pleased to announce the release of the first publication in a series of Guidelines for Reasonable and Appropriate Care in […].
BioSpace
JULY 6, 2021
bluebird bio is hitting back at Spark Therapeutics over the use of the word “spark” involving the company’s “Be the Spark” campaign against sickle cell disease.
Scienmag
JULY 6, 2021
Credit: IRB Barcelona Chromosomal instability is a feature of solid tumours such as carcinoma. Likewise, cellular senescence is a process that is highly related to cellular ageing and its link to cancer is becoming increasingly clear. Scientists led by ICREA researcher Dr. Marco Milán at IRB Barcelona have revealed the link between chromosomal instability and […].
Pharma Times
JULY 6, 2021
Doctors' union urges reconsideration of government plans to ditch mandatory wearing of facemasks
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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
JULY 6, 2021
New catalog information service corresponding to digital resources to be introduced from 2022 Credit: © National Institute of Informatics National Institute of Informatics (NII; Director General: Dr. KITSUREGAWA Masaru, Tokyo, Japan) has begun reconstruction of NACSIS-CAT/ILL, a catalog information service used by more than 1,300 institutions, mainly university libraries.
Outsourcing Pharma
JULY 6, 2021
The two entities will work together to evaluate digital sensors and other tools used in clinical research, checking the items for accuracy and equity.
Scienmag
JULY 6, 2021
Credit: Journal of Magnesium and Alloys Journal of Magnesium and Alloys (JMA) is delighted to announce that the Impact Factor (IF) of the journal is now 10.088 in 2020 according to the latest Clarivate Journal Citation Reports. JMA ranks No. 1 out of 80 journals (Q1 quartile) in the Metallurgy and Metallurgical Engineering category. Journal […].
BioSpace
JULY 6, 2021
University of Oxford researchers have begun clinical trials for a new vaccine that can potentially target a wide range of HIV variants.
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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
JULY 6, 2021
A study published in Nature Astronomy concludes that known geochemical processes can’t explain the levels of methane measured by the Cassini spacecraft on Saturn’s icy moon Credit: NASA An unknown methane-producing process is likely at work in the hidden ocean beneath the icy shell of Saturn’s moon Enceladus, suggests a new study published in Nature […].
BioSpace
JULY 6, 2021
Perseverance is the foundation of impactful scientific discoveries, and is a core value that Precision BioSciences’ newly-appointed chief medical officer, oncology giant Alan List, shares.
Scienmag
JULY 6, 2021
Credit: Lorna Dougan/Phospho Animations Scientists at the University of Leeds have developed an approach that could help in the design of a new generation of synthetic biomaterials made from proteins. The biomaterials could eventually have applications in joint repair or wound healing as well as other fields of healthcare and food production. But one […].
BioSpace
JULY 6, 2021
This appears to be a second example of CRISPR gene editing inside the body, as opposed to in cell cultures.
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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
JULY 6, 2021
Credit: Regenstrief Institute INDIANAPOLIS — Regenstrief Research Scientist and Indiana University School of Medicine Associate Professor Paul Biondich, M.D., M.S., has been elected as a 2021 fellow of the International Academy of Health Sciences Informatics (IAHSI). The Academy is a group of health science informatics leaders whose contributions are recognized internationally.
BioSpace
JULY 6, 2021
Two life sciences companies from two very different areas of medicine announced launches today. Here’s a look.
Scienmag
JULY 6, 2021
The study has been published in the Journal of Ethnobiology Credit: Joan de la Malla Five Simon Fraser University scholars are among international scientists sounding an alarm over the “pervasive social and ecological consequences” of the destruction and suppression of the knowledge systems of Indigenous Peoples and local communities. Their paper, published today in the […].
Pharma Times
JULY 6, 2021
Clearance in the UK is still pending and remains a requirement to complete the proposed deal
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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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