Bio Pharma Dive
NOVEMBER 2, 2021
The biotech has identified gene editing as a natural fit for the technology it uses to deliver its vaccines and drugs. A deal with Metagenomi, a startup backed by Bayer, will further those ambitions.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
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Bio Pharma Dive
NOVEMBER 2, 2021
The three-month delay could give an advantage to Bristol Myers Squibb, which holds the first approval for a CAR-T therapy for the blood cancer.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
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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
NOVEMBER 2, 2021
The biotech has officially filed for an accelerated review of its closely watched ALS drug, an outcome that seemed unlikely just a few months ago.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Deltaclinical
NOVEMBER 2, 2021
The sponsor of a study will assign one or multiple principle investigators (PI), usually a doctor. Along with a team of nurses and other stakeholders, the PI will conduct the trial at his/her study site. However, the sponsor will remain the monitor of the trial. The next figure shows the important stakeholders in a clinical trial. Traditionally, clinical trials have never been designed with patient-centricity in mind.
Bio Pharma Dive
NOVEMBER 2, 2021
Vaccinations could begin as soon as CDC director Rochelle Walensky signs off on the group's recommendation, a step expected to come quickly.
Scienmag
NOVEMBER 2, 2021
Increased mortality risk among current alcohol abstainers might largely be explained by other factors, including previous alcohol or drug problems, daily smoking, and overall poor health, according to a new study publishing November 2nd in PLOS Medicine by Ulrich John of University Medicine Greifswald, Germany, and colleagues. Credit: Alexas_Fotos, CCO ([link] Increased mortality risk among […].
BioSpace
NOVEMBER 2, 2021
The annual Clinical Trials on Alzheimer’s Disease conference is scheduled for November 9-12, and Biogen plans to present data on its portfolio, including its controversial Aduhelm.
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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
pharmaphorum
NOVEMBER 2, 2021
Rocketing sales of COVID-19 vaccine Comirnaty have allowed Pfizer to raise its full-year forecasts for the shot once again to a whopping $36 billion, more than double its predictions just a few months ago. Fuelled by extensions to vaccination programmes to include children and booster shots, the BioNTech-partnered jab made nearly $13 billion in the third quarter, around $2 billion more than analyst consensus forecasts.
BioSpace
NOVEMBER 2, 2021
This first-of-its-kind collaboration will leverage the talent and innovation at companies such as Tessera Therapeutics to advance multiple candidates to human proof of concept.
XTalks
NOVEMBER 2, 2021
The government of Scotland has rolled out a new C-peptide test for type 1 diabetes that could help patients monitor their insulin levels with greater accuracy. The test provides information about the amount of insulin a patient has in their body, which can help determine whether they can reduce or stop taking their insulin injections. The test measures levels of C-peptide protein in the blood, which is a byproduct of insulin synthesis that is released from the pancreas along with the hormone.
BioSpace
NOVEMBER 2, 2021
CytoDyn announced two separate stories about its drug leronlimab today, one for nonalcoholic steatohepatitis and the other for metastatic triple-negative breast cancer.
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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.
XTalks
NOVEMBER 2, 2021
While it is no secret that fast food is widely regarded as unhealthy, a new study found that numerous popular chains are serving up burgers with a side of harmful chemicals. The study , which was published last week in the Journal of Exposure Science & Environmental Epidemiology , showed that hormone-disrupting chemicals, known as phthalates, were prevalent in a wide range of fast-food items.
BioSpace
NOVEMBER 2, 2021
Immunology expert Constance Cullen of Schering-Plough Corp. revealed that Theranos inappropriately attached Schering-Plough’s logo to data issued to potential investors.
Scienmag
NOVEMBER 2, 2021
COLUMBIA, Mo. – Move over, Hollywood — science fiction is getting ready to leap off the big screen and enter the real world. While recent science fiction movies have demonstrated the power of artificially intelligent computer programs, such as the fictional character J.A.R.V.I.S. in the Avenger film series, to make independent decisions to carry out […].
BioPharma Reporter
NOVEMBER 2, 2021
BioNet and Sartoriusâ BIA Separations are collaborating on production process development of mRNA vaccines: today announcing an optimized mRNA manufacturing process.
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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
NOVEMBER 2, 2021
93% of clinicians felt that remote medicine was worse than in-person consultations in terms of accuracy
pharmaphorum
NOVEMBER 2, 2021
In only its second year of operations, Cambridge, UK startup Dunad Therapeutics has already attracted a big pharma partner for its protein degradation platform. Swiss group Novartis has swooped in with a backloaded option deal that includes $24 million upfront in cash and equity – plus up to $1.3 billion in milestones – and covers drug candidates against up to four disease targets.
BioSpace
NOVEMBER 2, 2021
This week, the U.S. Food and Drug Administration accepted Investigational New Drug Applications for multiple companies, clearing the way for clinical development.
Drug Channels
NOVEMBER 2, 2021
Open enrollment is under way for the 2022 Medicare Part D plans. Our exclusive analysis of Center for Medicare & Medicaid Services’ (CMS) data reveals that preferred cost sharing pharmacy networks will maintain their dominance as an established component of Part D benefit design. For 2022: 98% of stand-alone Medicare Part D prescription drug plans (PDP) will have a preferred network. 66% of Medicare Advantage prescription drug (MA-PD) plans will have a preferred network.
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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 2, 2021
This novel diagnostic technology uses augmented reality and a smartphone or tablet to administer cognitive and functional tests.
Scienmag
NOVEMBER 2, 2021
Around one in twenty people in Scotland diagnosed with type 2 diabetes achieve remission from the disease, according to research publishing November 2nd in the open-access journal PLOS Medicine. This suggests people are achieving remission outside of research trials and without bariatric surgery. Recognising individuals in remission, following their progress, and better understanding the factors […].
BioSpace
NOVEMBER 2, 2021
?Clade Therapeutics will use its funds to further its research and development on cancer treatments, while GRO Biosciences will focus on chronic diseases.
Scienmag
NOVEMBER 2, 2021
Deadlines often help motivate people to perform tasks that they’ve been procrastinating over, but different deadline lengths may have different effects. For example, while increasing the deadline length gives a person more time to complete a task, it also means that the task could be postponed until later and possibly forgotten. A recent study in […].
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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
NOVEMBER 2, 2021
Your CV can be the ticket that lands you your dream job - as long as you focus on making sure that it’s well-written and with these CV writing tips.
Scienmag
NOVEMBER 2, 2021
In the race against climate change, physicists at The University of Toledo are pushing the limits of solar electricity to ensure a clean energy future. Credit: Daniel Miller, The University of Toledo In the race against climate change, physicists at The University of Toledo are pushing the limits of solar electricity to ensure a clean […].
BioSpace
NOVEMBER 2, 2021
In November 2019, Emory realized this experimental drug could have significant potential in respiratory viruses such as COVID-19.
Scienmag
NOVEMBER 2, 2021
In every advanced organism, the molecule called DNA (deoxyribonucleic acid, to use its full name) forms the genetic code. Modern-day technology takes DNA one step beyond living matter; scientists have established that the intricate structures of DNA have made it possible for it to be used in new-age electronic devices with junctions comprising just a […].
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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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