World of DTC Marketing
JUNE 27, 2021
SUMMARY: According to the NEJM “in participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight” In the clinical study, participants were enrolled in an “intensive” behavioral study with 8 weeks low-calorie diet.
FDA Law Blog
JUNE 27, 2021
By Larry K. Houck — This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections. Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them. Part 1, posted May 3rd, examines the purpose, background and scope of DEA cyclic and on-site inspections.
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BioSpace
JUNE 27, 2021
Although the COVID-19 pandemic is waning in the U.S., it’s not completely over and there are some concerns, particularly with the delta variant, which originated in India. Here’s a look.
Scienmag
JUNE 27, 2021
Study points towards role of gut microbiome in vaccine effectiveness Credit: Image by Dr. Hiroshi Kiyono, CC BY 4.0 A new vaccine to protect against deadly cholera has been made by grinding up genetically modified grains of rice. The first human trial has shown no obvious side effects and a good immune response. Researchers based […].
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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
JAMA Internal Medicine
JUNE 27, 2021
This cohort study compares the risk of all-cause mortality in individuals using sodium-glucose cotransporter 2 inhibitors vs sulfonylureas in combination with metformin for treatment of type 2 diabetes.
BioSpace
JUNE 27, 2021
The trial is the third study in a set of pivotal trials to report positive data for the therapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JUNE 27, 2021
Eli Lilly and Novo Nordisk published their data in The Lancet Diabetes & Endocrinology and presented them at the ADA conference.
Pharma Times
JUNE 27, 2021
The vaccine has been designed with minor genetic alterations to the spike protein based on the beta (B.1.
BioSpace
JUNE 27, 2021
Ahead of the July Fourth holiday, the U.S. Food and Drug Administration has two PDUFA dates on the calendar. Here’s a look.
Pharma Times
JUNE 27, 2021
Positive CHMP opinion is based on results from the pivotal Phase II KarMMa study
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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 27, 2021
Polyphor said there has been no improvement in the results for FORTRESS, its Phase III global study for the possible treatment of patients with breast cancer.
Pharma Times
JUNE 27, 2021
All three doses of Lilly’s drug demonstrated superior HbA1C and body weight reductions compared to Ozempic
Scienmag
JUNE 27, 2021
In CTP class A patients, IGF/CTP score B was associated with shorter PFS and OS Credit: Correspondence to – Ahmed O. Kaseb – akaseb@mdanderson.org Oncotarget published “Insulin-like growth factor 1/Child-Turcotte-Pugh composite score as a predictor of treatment outcomes in patients with advanced hepatocellular carcinoma treated with sorafenib” which reported that this study investigated the association […].
BioSpace
JUNE 27, 2021
Australian scientists may have found a way to treat Alzheimer's disease using non-invasive methods.
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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
JUNE 27, 2021
Support recently reported findings of clinical benefit when relacorilant is added to paclitaxel-containing therapy in patients with ovarian and pancreatic cancers and provide a new rationale for combining relacorilant with additional cytotoxic agents Credit: Correspondence to – Andrew E. Greenstein – agreenstein@corcept.com Oncotarget published “Glucocorticoid receptor antagonism promotes apoptosis in solid tumor cells” which reported […].
BioSpace
JUNE 27, 2021
Adamis has sent a letter to stockholders urging them to re-elect all the five board members as part of a strategic move to continue and maintain its current growth initiatives.
Scienmag
JUNE 27, 2021
By incorporating cell composition into their regression model, they identified 3,193 differentially expressed genes, of which 556 were deemed novel Credit: Correspondence to – Graham Casey – gc8r@virginia.edu Oncotarget published “The presence of polymorphisms in genes controlling neurotransmitter metabolism and disease prognosis in patients with prostate cancer: a possible link with schizophrenia” reported that polymorphisms […].
Drug Patent Watch
JUNE 27, 2021
Annual Drug Patent Expirations for VYLEESI+%28AUTOINJECTOR%29 Vyleesi (autoinjector) is a drug marketed by Palatin Technologies and is included in one NDA. It is available from one supplier. There are five…. The post New patent expiration for Palatin Technologies drug VYLEESI (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.
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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
JUNE 27, 2021
Development of anti-cancer drugs that boost patient immunity. Potential for immunotherapy drug with no side effects Credit: Korea Institute of Science and Technology(KIST) Unlike conventional cancer drugs that attack and kill cancer cells directly, anti-cancer immunotherapy, which kills cancer cells by strengthening the body’s immunity, is a novel type of cancer treatment currently attracting increased […].
Drug Patent Watch
JUNE 27, 2021
Annual Drug Patent Expirations for FERRIPROX Ferriprox is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. There are five patents protecting…. The post New patent expiration for Chiesi drug FERRIPROX appeared first on DrugPatentWatch - Make Better Decisions.
Scienmag
JUNE 27, 2021
Credit: Sanford Burnham Prebys LA JOLLA, CALIF. – June 29, 2021 – Carl F. Ware, Ph.D., director of the Inflammatory Diseases Center at Sanford Burhnam Prebys, has received the 2021 International Cytokine & Interferon Society Honorary Lifetime Membership Award. The award is a tribute to his seminal and original contributions to our understanding of the […].
Drug Patent Watch
JUNE 27, 2021
Annual Drug Patent Expirations for SUSTOL Sustol is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are seven…. The post New patent expiration for Heron Theraps drug SUSTOL appeared first on DrugPatentWatch - Make Better Decisions.
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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 Channels
JUNE 27, 2021
Happy 245th birthday, America! As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing. P.S.
Clinical Trial Gurus
JUNE 27, 2021
For us working on the clinical side of research it is sometimes easy to not think about what happens before the trial goes clinical. Enter pre-clinical, and even earlier, protocol planning and regulatory affairs. In this video I interview a medical writer who works full time at performing just these tasks.
BioSpace
JUNE 27, 2021
The House Committee on Oversight and Reform announced plans to investigate the approval and pricing of the drug. Biogen, on its part, has defended its pricing.
Pharma Times
JUNE 27, 2021
Bimzelx inhibits IL-17A and IL-17F, two key cytokines that drive inflammatory processes
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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 27, 2021
The U.S. FDA granted Fast Track Designation to three biopharma companies for the treatment of LGMD, episodic bleeding and leukemia.
Scienmag
JUNE 27, 2021
Sophia Antipolis – 28 June 2021: A study in more than 200,000 individuals has found that patients with heart failure are more likely to develop cancer compared to their peers without heart failure. The research is presented today at Heart Failure 2021, an online scientific congress of the European Society of Cardiology (ESC),1 and published […].
BioSpace
JUNE 27, 2021
She takes over the role held by oncology research legend José Baselga, who passed away in March from a neurodegenerative disease.
Scienmag
JUNE 27, 2021
COVID-19-positive patients with traumatic injuries have six times higher risk of death and complication than patients without COVID, Penn Medicine research shows PHILADELPHIA– In addition to sickening and taking the lives of millions across the globe, COVID-19 complicated patient care in a range of less-direct ways, from increased incidence of heart attacks to decreased cancer […].
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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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