Bio Pharma Dive
OCTOBER 18, 2021
Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.
NY Times
OCTOBER 18, 2021
The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.
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Bio Pharma Dive
OCTOBER 18, 2021
The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines.
pharmaphorum
OCTOBER 18, 2021
Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or more cells express the PD-L1 biomarker, to try to stop the cancer recurring.
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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
OCTOBER 18, 2021
Too often, optimized prescreening is overlooked in favor of the status quo. Here's why that's a mistake—and why prescreening is the great missed opportunity for modern-day trial enrollment.
BioSpace
OCTOBER 18, 2021
While it has yet to reach clinical trials, preclinical results with the company’s specially-tailored adeno-associated virus have been fortuitously auspicious.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 18, 2021
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
Bio Pharma Dive
OCTOBER 18, 2021
The interchangeable approval could help to boost adoption of Boehringer's biosimilar when it launches in mid-2023, a date set by a legal settlement with AbbVie.
BioSpace
OCTOBER 18, 2021
With the Delta variant of coronavirus spreading globally, the pandemic still has a tight grip on the world. Many people around globe are struggling to come to terms with the aftermath of the pandemic, much like a century ago with the Spanish flu.
Pharma Times
OCTOBER 18, 2021
Dupilumab (also known as Dupixent) will be available to patients through injections
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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
OCTOBER 18, 2021
Cartesian’s Descartes-08 is a new chimeric antigen receptor (CAR)-T cell therapy that aims to target the disease at its source: the deviant antibody-secreting plasma cells.
BioPharma Reporter
OCTOBER 18, 2021
AION Labs, a âfirst-of-its-kindâ innovation lab that will create and adopt AI technology to transform the process of drug discovery and development, has officially launched this month.
XTalks
OCTOBER 18, 2021
Medical laboratory scientists, often referred to as medical technologists or clinical laboratory scientists, analyze a variety of biological specimens. More specifically, they perform scientific testing on samples and report results to physicians. Using sophisticated equipment like microscopes, medical laboratory scientists examine and analyze blood, body fluids, tissues and cells.
Pharma Times
OCTOBER 18, 2021
Interstitial lung disease (ILD) is a termed used to describe a collection of over 200 lung disorders
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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
OCTOBER 18, 2021
We’ve heard of almond, cashew and even macadamia nut milks, but a new nut has entered the plant-based dairy market: pecans. While some plant-based consumers have been making homemade pecan milk for years, a few startups are hoping to make it a popular entrant to the alternative dairy space. . So, why pecans? While nearly any nut can be transformed into an alternative dairy beverage, pecans are less labor intensive and waste free.
BioSpace
OCTOBER 18, 2021
With expectations that the U.S. FDA will announce a decision about booster shots for the Moderna and Johnson & Johnson vaccines this week, there is plenty of COVID-19-related news. Here’s a look.
BioPharma Reporter
OCTOBER 18, 2021
Pharma and biopharma companies need to reevaluate the measures they are currently taking against ever-evolving cybercrime tactics, says an expert.
BioSpace
OCTOBER 18, 2021
On Monday, LogicBio Therapeutics unveiled clinical trial results demonstrating the first-ever in vivo, nuclease-free genome editing in little humans.
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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.
Outsourcing Pharma
OCTOBER 18, 2021
According to the firm, infectious-disease research advancements could be applied to discovering treatments for millions of hepatitis patients globally.
BioSpace
OCTOBER 18, 2021
June really broke out in 2012 when he saved the life of Emily Whitehead, a child suffering from relapsed acute lymphoblastic leukemia (ALL), with CD19 CAR-T.
Outsourcing Pharma
OCTOBER 18, 2021
A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.
BioSpace
OCTOBER 18, 2021
?Zimhi is indicated for use in both adults and children in the event of an emergency. It is to be given right away and does not take the place of emergency care.
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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.
Pharma Times
OCTOBER 18, 2021
MindPod pioneers the world’s first immersive neuro-animation experience
BioSpace
OCTOBER 18, 2021
Vertex Pharmaceuticals announced positive Day 90 data from the first patient in its Phase I/II study of VX-880 in type 1 diabetes.
BioPharma Reporter
OCTOBER 18, 2021
Touchlight, a synthetic DNA producer, says it has received the first phase of planning approval for breaking ground on its new research and manufacturing facility in Hampton, UK.
BioSpace
OCTOBER 18, 2021
Calithera Biosciences is expanding its oncology portfolio with the addition of two clinical-stage compounds from Takeda Pharmaceuticals.
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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.
Outsourcing Pharma
OCTOBER 18, 2021
A study from Climedo Health aims at revealing the growing influence the decentralized format is enjoying across the industry and what might lie ahead.
BioSpace
OCTOBER 18, 2021
Biopharma companies recognized that developing a therapy is merely the beginning of what is needed to connect patients with sickle cell disease to next-level therapies.
ECRG Media's Clinical Research Podcast
OCTOBER 18, 2021
What It Was Like Being a CRA Before and During The Pandemic Don't forget to Subscribe for new content! Merch: [link] [link] eliteclinicalgroup@gmail.com Podcast: [link] [link] eliteclinicalgroup@gmail.com Watch: » Industry News: [link] All Videos: [link] Interview Recaps: [link] Glassdoor Reviews: [link] We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education Elite Clinical Research Group or ECRG for short i
Scienmag
OCTOBER 18, 2021
Lift the lid on an electrified home, a factory, or a mine, and you’ll find a troop of squirrel cage motors active at all hours. Industrialised nations wouldn’t be nearly as industrial without these. Credit: Video by Therese van Wyk, University of Johannesburg. Flow charts by Dr Mbika Muteba, as part of ‘Optimization of Air […].
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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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