Bio Pharma Dive
JULY 13, 2021
A deal with Innocare gives Biogen a second therapy for MS that targets a protein called BTK, an approach several other competing drugmakers are pursuing, too.
World of DTC Marketing
JULY 13, 2021
SUMMARY: The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs. The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process. The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
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Pharma Times
JULY 13, 2021
Researchers discover presence of 'autoantibodies' in people with persistent COVID-19 symptoms
pharmaphorum
JULY 13, 2021
Faced with a looming mental health crisis, the UK government has been urged to invest in the digitisation of service provision across the NHS in England in a new report from think tank Future Care Capital. The study’s author – FCC’s head of policy and research Dr Peter Bloomfield, argues that there has been a lack of support for mental health services for many years in the UK, and the pathways for accessing them are “convoluted, waiting lists are extensive, and outcomes are po
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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
Pharma Times
JULY 13, 2021
In 2020, the two partners announced an initial collaboration to integrate Cegedim’s ‘THIN’ European real-world data into Aetion’s evidence platform
pharmaphorum
JULY 13, 2021
Diagnosing Alzheimer’s disease is still a challenge, particularly in its earliest stages, but a new study suggests that subtle changes in behaviour whilst driving could serve as an early warning system. The researchers used GPS logging devices and machine learning as “digital biomarkers” to compare the driving of people who have preclinical Alzheimer’s but are still cognitively normal to a control group of normal age-matched drivers over the course of a year.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 13, 2021
Diabetes giant Novo Nordisk has opened a new front in its rare disease R&D, thanks to an acquisition agreement with Prothena focusing on drugs for ATTR amyloidosis. The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system.
BioSpace
JULY 13, 2021
Kevin Mulleady and Jason Aryeh attempted to back a slate of candidates for the Phoenixus Board of Directors but failed as shareholders overwhelmingly supported the current board.
BioPharma Reporter
JULY 13, 2021
Scotland will soon have access to the Novartis drug, Kesimpta, (ofatumumab), the first self-administered, targeted B-cell therapy for patients with relapsing remitting multiple sclerosis (RRMS).
BioSpace
JULY 13, 2021
Thermo Fisher Scientific has launched a new collaborative unit that aims to standardize the metabolomics community's efforts as it engages in more large-scale cohort studies and clinical research.
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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
XTalks
JULY 13, 2021
Researchers at Imperial College London recently discovered the presence of autoantibodies in the blood of long COVID patients, opening up the possibility for the condition to be diagnosed with a simple blood test. The autoantibodies were found exclusively in the blood of patients with long COVID and not in the blood of people who had recovered quickly from the infection, or who did not test positive for it.
Scienmag
JULY 13, 2021
Excess urban heat is common within cities, but not all communities burden the consequences equally, according to new UC San Diego research Credit: UC San Diego Low-income neighborhoods and communities with higher Black, Hispanic and Asian populations experience significantly more urban heat than wealthier and predominantly white neighborhoods within a vast majority of populous U.S. […].
XTalks
JULY 13, 2021
The ICH E6(R3) Expert Working Group (EWG) is currently working to revise the E6(R2) Good Clinical Practice (GCP) guidelines with a focus on the growing inclusion of diverse trial types and data sources in clinical trials. This includes the increasing use of new digital technologies in trials. The new guidelines will offer flexibility, when appropriate, to enable the use of technological innovations in trials and leverage it to identify and manage risks.
Scienmag
JULY 13, 2021
Credit: Virginia Tech’s Niki Hazuda. At the intersection of change, impact, diversity, equity, and inclusion, stands an assistant professor from the Department of Engineering Education at Virginia Tech: Jeremi London. With her recent National Science Foundation CAREER grant, London is poised to tackle one of today’s most pressing questions for engineering: Who gets to be […].
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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
JULY 13, 2021
The WHO panel recommends adopting global standards, giving structure to prevent the unscrupulous, inequitable, and possibly dangerous uses of CRISPR technology.
Scienmag
JULY 13, 2021
CEA is not associated with survival outcomes in SCCA, and is not a clinically relevant biomarker in this disease Credit: Correspondence to – Van K. Morris – vkmorris@mdanderson.org Oncotarget published “CEA as a blood-based biomarker in anal cancer” which reported that the mean Carcinoembryonic Antigen (CEA) among subgroups by clinical status at the time of […].
BioSpace
JULY 13, 2021
The new CEO of Freenome has a talent for “making his own weather.” That’s a phrase he heard often growing up in Rapid City, South Dakota and, when applied to his life and career, comes down to assessing himself accurately and looking for opportunities to contribute.
Scienmag
JULY 13, 2021
Mathematicians and neuroscientists achieve breakthrough in understanding how whiskers ‘amplify’ texture Credit: Nature Scientific Reports How we sense texture has long been a mystery. It is known that nerves attached to the fingertip skin are responsible for sensing different surfaces, but how they do it is not well understood. Rodents perform texture sensing through their […].
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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
JULY 13, 2021
SMC was unable to accept Pfizer’s Vyndaqel for use in patients with transthyretin amyloidosis
Scienmag
JULY 13, 2021
Credit: @Science China Press The human brain has extreme ability in thinking and computation, but it only requires a very low energy power of about 20W, which is much lower than that of electronic computers. The neuronal connections in the brain network have a globally sparse but locally compact modular topological characteristics, which greatly reduces […].
Pharma Times
JULY 13, 2021
Company’s molecular testing platform and first assay panel can now be marketed in the EU
Scienmag
JULY 13, 2021
Credit: Deutsches Bergbau-Museum Bochum and Zanjan Cultural Heritage Centre, Archaeological Museum of Zanjan. A team of geneticists and archaeologists from Ireland, France, Iran, Germany, and Austria has sequenced the DNA from a 1,600-year-old sheep mummy from an ancient Iranian salt mine, Chehr?b?d. This remarkable specimen has revealed sheep husbandry practices of the ancient Near East, […].
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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
JULY 13, 2021
Through its OrbNet platform, Entos has already forged various partnerships with investors and leaders in the pharmaceuticals, materials, and chemicals industries.
Scienmag
JULY 13, 2021
Disparities of care and limitations of access are the main focus of this special issue on cerebral palsy, published by the Journal of Pediatric Rehabilitation Medicine Credit: Journal of Pediatric Rehabilitation Medicine. Amsterdam, July 13, 2021 – Cerebral palsy (CP) is one of the most common developmental movement disorders in children. It is associated with […].
BioPharma Reporter
JULY 13, 2021
The World Health Organization yesterday warned there is not yet enough evidence to support the strategy of mixing and matching different COVID-19 vaccine types.
Scienmag
JULY 13, 2021
Credit: Natalis Lorenz No longer science fiction, farm robots are already here–and they have created two possible extremes for the future of agriculture and its impacts on the environment, argues agricultural economist Thomas Daum in a Science & Society article published July 13 in the journal Trends in Ecology & Evolution. One is a utopia, […].
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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
JULY 13, 2021
No specific financial details were disclosed other than to say the $1 billion figure was linked to various development and commercial milestones.
Scienmag
JULY 13, 2021
Credit: Jasper Halekas lab, University of Iowa As the Parker Solar Probe ventures closer to the sun, we are learning new things about our home star. In a new study, physicists led by the University of Iowa report the first definitive measurements of the sun’s electric field, and how the electric field interacts with the […].
BioSpace
JULY 13, 2021
The medication, should it be approved for use, will be squirted into the nasal passages, ensuring absorption into the body and reverses the overdose effects.
Scienmag
JULY 13, 2021
Certain countries perform significantly better than their neighbors in the effectiveness of their protected areas, finds new study. Credit: Pixabay Researchers have conducted a global study on the effectiveness of recently established protected areas in preventing forest loss The study explores protected area performance by countries, with South Africa, Cambodia, Latvia, Guatemala, Uruguay, Brazil and […].
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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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