JAMA Internal Medicine
NOVEMBER 7, 2021
This cross-sectional study of individuals from the French CONSTANCES cohort assesses whether the belief in having been infected with SARS-CoV-2, having serological test–confirmed COVID-19 infection, or both are associated with persistent physical symptoms often attributed to long COVID in the general adult population.
BioSpace
NOVEMBER 7, 2021
Researchers aren’t sure why the mRNA vaccines appear to, in rare cases, cause heart inflammation. The FDA said the risk appears higher within seven days of the second jab of the vaccines.
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Scienmag
NOVEMBER 7, 2021
Majestic flippers instead of legs put the “sea” in sea lions, yet in New Zealand, the endangered beasts are dragging their bulky way back to forests and back yards in a story of conservation success and complicated opportunities. Credit: Janet Ledingham Majestic flippers instead of legs put the “sea” in sea lions, yet in New […].
BioSpace
NOVEMBER 7, 2021
While some get the jab faithfully each flu season, about half of the American population declines, likely over doubts of the vaccine’s effectiveness and necessity.
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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
Scienmag
NOVEMBER 7, 2021
A ground-breaking new, mobile phone app, ‘GrowthMonitor’ places the accurate measurement of children’s height in the hands of parents and carers. Preliminary data to be presented at the Society for Endocrinology annual conference in Edinburgh suggests that the app could reliably identify treatable growth disorders, much earlier, with significant improvements in child health.
BioSpace
NOVEMBER 7, 2021
Regeneron Pharmaceuticals announced more positive findings from its ongoing Phase III trial on the use of REGEN-COV to prevent COVID-19 in uninfected persons who have been exposed to the virus.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 7, 2021
Kindness. Respect. Innovation. Only one of those words typically features in biotech mission statements, but at Ikena Oncology, all three are important – and have been from day one.
Scienmag
NOVEMBER 7, 2021
Oncotarget published “Correlation between PD-L1 expression and MET gene amplification in patients with advanced non-small cell lung cancer and no other actionable oncogenic driver” which reported that herein, the authors investigated the relation between MET gene amplification and PD-L1 expression in patients with advanced NSCLC and no other actionable oncogenic driver.
BioSpace
NOVEMBER 7, 2021
?Autolus is currently working on advancing obecabtagene autoleucel, its CD19 CAR T cell investigational therapy product candidate, in addition to other applications of obe-cel in B-cell malignancies.
Scienmag
NOVEMBER 7, 2021
A UCLA study has found that young adults who have experienced discrimination have a higher risk for both short- and long-term behavioral and mental health problems. Credit: Joice Kelly/Unsplash A UCLA study has found that young adults who have experienced discrimination have a higher risk for both short- and long-term behavioral and mental health problems. […].
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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
NOVEMBER 7, 2021
GlaxoSmithKline is lining up a potential new treatment for patients with anemia due to chronic kidney disease following positive results in a Phase III study.
Scienmag
NOVEMBER 7, 2021
Philadelphia, November 8, 2021 – As Black women continue to have the lowest breastfeeding initiation and duration rates in the United States, researchers examined factors associated with breastfeeding disparities and inequities through the lens of critical race theory and the social-ecological model in a new Perspective in the Journal of Nutrition Education and Behavior, published […].
BioSpace
NOVEMBER 7, 2021
The merger between Blade Therapeutics and Biotech Acquisition Company will provide the company with $254.3 million to drive the development of cudetaxestat.
Scienmag
NOVEMBER 7, 2021
Patients with two out of the three most common types of advanced breast cancer now have an average survival time of at least five years, according to a panel of experts at the Advanced Breast Cancer Sixth International Consensus Conference (ABC 6). [1] Credit: Champalimaud Cancer Centre, Lisbon, Portugal Patients with two out of the […].
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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
NOVEMBER 7, 2021
The $80 million infusions from ATP will advance Marengo’s lead candidate, STAR0602, which aims to treat advanced and metastatic solid tumors.
pharmaphorum
NOVEMBER 7, 2021
Shares in Deciphera Pharma went into freefall on Friday after top-line results of a phase 3 trial of its Qinlock in rare cancer gastrointestinal stromal tumour (GIST) dashed its hopes of moving the drug earlier in treatment. KIT inhibitor Qinlock (ripretinib) was by the FDA last year as a fourth-line therapy for GIST in adults who have received prior treatment with three or more kinase inhibitor therapies, including tyrosine kinase inhibitor (TKI) imatinib, sold by Novartis as Gleevec and also a
BioSpace
NOVEMBER 7, 2021
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
FDA Law Blog
NOVEMBER 7, 2021
By Faraz Siddiqui & Alan M. Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement.
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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.
BioSpace
NOVEMBER 7, 2021
Trying to develop a career in pharma may be overwhelming when you think about it. However, this article can help!
Scienmag
NOVEMBER 7, 2021
Unravelling the entire genetic code for each child who has been diagnosed with cancer can give a more accurate diagnosis or reveal new treatment options, according to research presented at the NCRI Festival.[1] These are the results of a pilot study of the process known as whole genome sequencing. Credit: NCRI/Patrick Tarpey Unravelling the entire […].
BioSpace
NOVEMBER 7, 2021
?Bristol Myers Squibb’s Phase III CheckMate -816 trial hit the primary endpoint in an interim analysis.
BioTech 365
NOVEMBER 7, 2021
Masimo Root® with a Multimodal Brain Monitoring Algorithm May Improve Postoperative Neurocognition in Elderly Patients Masimo Root® with a Multimodal Brain Monitoring Algorithm May Improve Postoperative Neurocognition in Elderly Patients NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the findings of … Continue reading →
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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
NOVEMBER 7, 2021
The first week of November was marked by numerous clinical trial announcements. Here’s a look.
BioTech 365
NOVEMBER 7, 2021
CLINUVEL Expands Pharmaceutical Portfolio CLINUVEL Expands Pharmaceutical Portfolio Melanocortin drug NEURACTHEL® (ACTH) added for neurological, endocrinological and degenerative disorders MELBOURNE, Australia, Nov.
BioSpace
NOVEMBER 7, 2021
Here’s a look at some of the hottest life sciences SPAC merger announcements so far in 2021.
Drug Patent Watch
NOVEMBER 7, 2021
Abaloparatide is the generic ingredient in one branded drug marketed by Radius Health Inc and is included in one NDA. There are four patents protecting this compound. This ingredient has…. The post New tentative approval for Radius Health drug abaloparatide appeared first on DrugPatentWatch - Make Better Decisions.
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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
NOVEMBER 7, 2021
HUTCHMED Highlights HMPL-523 Clinical Data to be Presented at the 2021 ASH Annual Meeting HUTCHMED Highlights HMPL-523 Clinical Data to be Presented at the 2021 ASH Annual Meeting HONG KONG, Shanghai and FLORHAM PARK, N.J., Nov.
Drug Patent Watch
NOVEMBER 7, 2021
This chart shows the drugs with the most patents in Iceland. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Iceland? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
NOVEMBER 7, 2021
Sorrento Awarded California Competes Tax Credit Sorrento Awarded California Competes Tax Credit SAN DIEGO, Nov. 07, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc.
pharmaphorum
NOVEMBER 7, 2021
The US Federal Court of Appeals has issued a temporary stay on President Joe Biden’s plan for mandatory COVID-19 vaccinations for employees of businesses. The mandate says that workers in privately-owned businesses with over 100 employees would have the be fully vaccinated by 4 January, or be required to take weekly COVID-19 tests and wear masks.
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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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