BioSpace
DECEMBER 5, 2021
The company said the study demonstrated broad efficacy, showing statistically significant superiority to placebo over a total of 15 prespecified primary and secondary outcome measures.
NY Times
DECEMBER 5, 2021
Powerful associates of Syria’s president, Bashar al-Assad, are making and selling captagon, an illegal amphetamine, creating a new narcostate on the Mediterranean.
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BioSpace
DECEMBER 5, 2021
The regulatory agency just placed new safety warnings on that drug class, which will impact AbbVie's Rinvoq (upadacitinib), a drug the company has seen as a successor to its revenue-driving Humira.
Scienmag
DECEMBER 5, 2021
An international study led by the Institute of Environmental Science and Technology of the Universitat Autònoma de Barcelona (ICTA-UAB) and the Department of Animal Health and Anatomy of the UAB shows that knowledge of Amazonian inhabitants can be a game changer in the rush for assessing animal population trends in a context of urgent need for conservation strategies and limited financial resources.
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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
DECEMBER 5, 2021
The latest updates from Mesoblast Limited's Phase III trial on rexlemestrocel-L show that the drug provides the highest benefit when used in patients with certain types of chronic heart failure.
Scienmag
DECEMBER 5, 2021
Most of the methane gas emitted from Amazon wetlands regions is vented into the atmosphere via tree root systems – with significant emissions occurring even when the ground is not flooded, say researchers at the University of Birmingham. In a study published in the Royal Society journal, Philosophical Transactions A, the researchers have found evidence […].
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
DECEMBER 5, 2021
PITTSBURGH, Dec. 6, 2021 – In a concerning trend for the health of U.S. children, the rate of underinsured youngsters rose from 30.6% to 34%—an additional 2.4 million kids—from 2016 to 2019, according to an analysis led by University of Pittsburgh School of Medicine researchers. Credit: UPMC PITTSBURGH, Dec. 6, 2021 – In a concerning trend for the health of U.S. children, the rate of underinsured youngsters rose from […].
BioSpace
DECEMBER 5, 2021
The U.S. Food and Drug Administration is wrapping up 2021 with a fairly busy schedule for the month of December. Here’s a look at the first half of the month.
JAMA Internal Medicine
DECEMBER 5, 2021
This cohort study analyzing data obtained from the Adult Changes in Thought study assesses whether cataract extraction is associated with reduced risk of dementia among adults 65 years of age or older.
BioSpace
DECEMBER 5, 2021
ADI-001 generated positive early responses from three of four evaluable participants, two of whom achieved complete responses while one had a partial response that researchers logged as "near complete.
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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
DECEMBER 5, 2021
Strengthening synergies between culture and climate science in the common fight against climate change will be at the centre of the first ever meeting organised jointly by the United Nations Educational, Scientific and Cultural Organization (UNESCO), the Intergovernmental Panel on Climate Change (IPCC) and the International Council on Monuments and Sites (ICOMOS) from 6 to […].
BioSpace
DECEMBER 5, 2021
Life sciences investors are being anything but shy as the end of 2021 draws near. Here are a few companies that are still seeing cash come in the door as December gets underway.
Scienmag
DECEMBER 5, 2021
Innovation Square (I2) Accelerator, the global startup accelerator program of the Okinawa Institute of Science and Technology Graduate University (OIST), is now accepting applications from driven, entrepreneurial teams for its 2022 program. Launched in 2019 in collaboration with the Okinawa Prefectural Government, the I2 Accelerator is a 12-month startup incubation program taking place on-site in […].
BioSpace
DECEMBER 5, 2021
In what is sure to create widespread skepticism — or enthusiasm, a study published in Nature Aging found that use of erectile dysfunction medication Viagra was associated with a 69% lower incidence of Alzheimer’s disease.
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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
DECEMBER 5, 2021
New technology could help doctors make the most of limited resources during the COVID-19 pandemic by identifying patients who require intensive care unit (ICU) treatment. The system, developed by researchers at the University of Waterloo and DarwinAI, an alumni-founded startup company, uses artificial intelligence (AI) to predict the necessity of ICU admission based on more […].
BioSpace
DECEMBER 5, 2021
An investigational drug for Dravet syndrome is showing promise in treating the progressive form of genetic epilepsy.
Drug Channels
DECEMBER 5, 2021
Better Data, Better Outcomes: A LexisNexis ® Risk Solutions and Q1 Productions Webinar. December 14, 2021 1:00 pm ET. This webinar is scheduled for a 45 minute presentation followed by 10 to 15 minutes of Q&A. Click here to register for this complimentary webinar. Your business depends on the data collected everyday across healthcare. That data not only drives the validation of the products and services your company offers today, but it also generates opportunities for new products and servi
BioSpace
DECEMBER 5, 2021
Heading out of November and into December, plenty of companies had clinical trial news to report. Here’s a look.
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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
DECEMBER 5, 2021
Restrictions in access to care during the COVID-19 pandemic caused disruptions in the treatment of cancer and other conditions. A new study now indicates that the pandemic also likely caused new cancer diagnoses to be delayed, a situation that could lead to worse prognoses for patients. The findings are published by Wiley online in CANCER, a […].
BioSpace
DECEMBER 5, 2021
In the staff documents, the FDA scientists expressed concerns over the Reata clinical data that was submitted.
Pharma Tutor
DECEMBER 5, 2021
Plum for Skin, Hair & Healthcare. About Authors. Monika Chamoli 1 , Upma Singh 2 , Raaz K. Maheshwari 3 *. 1 Department of Applied Sciences, Pt LR College of Technology, Faridabad, Haryana. 2 Department of Applied Chemistry, School of Vocational Studies & Applied Sciences, Gautam Buddha University, Gautam Buddha Nagar, Greater Noida, UP. 3 Department of Chemistry, SBRM Govt PG College, Nagaur, Rajasthan.
BioSpace
DECEMBER 5, 2021
Data is still coming in from South Africa and other regions about the new Omicron variant of COVID-19. Early analysis suggests it causes less severe disease than other 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.
Drug Patent Watch
DECEMBER 5, 2021
Annual Drug Patent Expirations for OFIRMEV Ofirmev is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from two suppliers. There are five patents…. The post New patent expiration for Mallinckrodt Hosp drug OFIRMEV appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
DECEMBER 5, 2021
?The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.
JAMA Internal Medicine
DECEMBER 5, 2021
This case report presents the electrocardiogram findings of a patient in their 50s with type 2 diabetes who presented to the emergency department with confusion and falls.
BioSpace
DECEMBER 5, 2021
A major factor behind the success of the smallpox eradication campaign was political commitment and leadership.
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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.
BioTech 365
DECEMBER 5, 2021
ABIONYX Pharma Announces the Completion of a Contribution in Kind to the Company of 100% of the Capital of IRIS Pharma Holding, Fully Compensated by the Issue of New Shares at a Price of €3.
Drug Patent Watch
DECEMBER 5, 2021
This chart shows the pharmaceutical companies with the most implant dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most implant dosed drugs…. The post Which pharmaceutical companies have the most implant dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
DECEMBER 5, 2021
Poxel Announces the Formation of its Scientific Advisory Board for Rare Metabolic Diseases Poxel Announces the Formation of its Scientific Advisory Board for Rare Metabolic Diseases LYON, France–(BUSINESS WIRE)–POXEL SA (Euronext – POXEL – FR0012432516), a clinical stage biopharmaceutical company … Continue reading →
BioTech 365
DECEMBER 5, 2021
Junshi Biosciences Announces FDA Expanded Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Individuals under the Age of 12 Junshi Biosciences Announces FDA Expanded Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Individuals under … Continue reading →
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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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