Bio Pharma Dive
OCTOBER 12, 2021
The gene editing company aims to expand its trial and add a second dose to improve effectiveness. However, safety worries have emerged since the FDA ordered CRISPR's rival Allogene to suspend clinical work.
pharmaphorum
OCTOBER 12, 2021
Value-based, person-centred healthcare is the key to system resilience – and now is the time to make it happen. COVID-19 offers a “unique opportunity” to build healthcare systems that are both agile enough to deal with future crises and strong enough to overcome existing challenges. That’s according to a new policy paper from the European Alliance for Value in Health.
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Bio Pharma Dive
OCTOBER 12, 2021
For an upfront payment of $45 million, Takeda gains access to as many as eight programs from Poseida Therapeutics and a potential method of delivering gene therapies without the help of viruses.
pharmaphorum
OCTOBER 12, 2021
A data-mining study conducted by researchers in the US has found that an already-approved diuretic drug could have potential as a treatment for some patients with Alzheimer’s disease. The research by a team of National Institutes of Health (NIH) scientists found that people who took bumetanide, a generic drug usually used to treat heart failure and oedema, had a significantly lower prevalence of Alzheimer’s compared to those not taking the drug.
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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 12, 2021
The German biotech has abandoned plans to seek approval of the shot in Europe, citing tough competition, waning demand and the progress of a second candidate it's developing with GlaxoSmithKline.
XTalks
OCTOBER 12, 2021
Today is World Arthritis Day (WAD) and this year’s theme is “Don’t Delay, Connect Today,” initiated by the European Alliance of Associations for Rheumatology ( EULAR ), to help raise awareness about the early diagnosis of rheumatic and musculoskeletal diseases (RMD). Arthritis is a chronic disease that afflicts one in four Americans. But there could soon be a path to prevention of the disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
OCTOBER 12, 2021
Roche’s Actemra has been in high demand since its value in treating severe COVID-19 was established, leading to shortages. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints. Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors – will be short until early 2022 based on current demand.
Drug Patent Watch
OCTOBER 12, 2021
This paper was originally published by Md. Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Reporter
OCTOBER 12, 2021
CureVac is withdrawing its first-generation COVID-19 vaccine candidate, CVnCoV, from regulatory review: instead it is re-allocating its efforts to its second-generation vaccine program with GSK. âThe goal has not changed, but the requirements to effectively address the virus and emerging variants have changed,â says the company.
BioSpace
OCTOBER 12, 2021
It’s not the COVID-19 vaccine that will get you. The real cause for concern is the virus, and it lies in the fact that both male and female reproductive organs contain cell receptors the virus targets.
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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
OCTOBER 12, 2021
Supernus has boosted its position in central nervous system therapies with a $400 million deal to acquire Adamas Pharma that will add two approved Parkinson’s disease therapies to its stable. The deal will diversify Supernus’ revenues and reduce its reliance on Trokendi XR (topiramate), a drug for migraine prevention and epilepsy that currently accounts for around half its revenues.
BioSpace
OCTOBER 12, 2021
At the virtual Congress of the ECTRIMS meeting this week, multiple companies present data for ongoing studies of therapies for multiple sclerosis. BioSpace takes a look at some of the data.
Pharma Times
OCTOBER 12, 2021
Phase Ib CodeBreaK study evaluated Lumakras in over ten different investigational combination regimens
BioSpace
OCTOBER 12, 2021
Seattle-based Immusoft announced it had inked a research pact and license option deal with Takeda to create, develop, and market cell therapies in rare inherited metabolic diseases with CNS manifestations and complications.
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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.
Drug Channels
OCTOBER 12, 2021
Payers have long sought to disrupt the buy-and-bill channel. Coming out of the pandemic (maybe?), specialty pharmacies—via white, brown, and clear bagging—continue to displace buy-and-bill distribution channels for provider-administered oncology drugs. Check out the latest 2021 data below. The battle for the specialty patient pits hospitals against insurers—and their respective specialty pharmacies.
BioSpace
OCTOBER 12, 2021
?A large part of the funding will go to the research and development of CIN-107 as it has shown the potential to treat primary aldosteronism and treatment-resistant hypertension.
Outsourcing Pharma
OCTOBER 12, 2021
The AI technology firm and pharma services company are joining to help one of the countryâs leading pharmaceutical firms develop a promising drug candidate.
BioSpace
OCTOBER 12, 2021
Genome-editing company Intellia Therapeutics and France-based SparingVision have partnered to develop new therapies for ocular diseases. The deal could be worth up to $600 million for Intellia.
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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
OCTOBER 12, 2021
The new consumer healthcare company will be based at a newly built campus in Weybridge
BioSpace
OCTOBER 12, 2021
While you might not be a professional job seeker, you can make employers think you are to get the results you’re looking for by avoiding these common job searching mistakes in the future.
Pharma Times
OCTOBER 12, 2021
AZD7442 cut the risk of severe COVID-19 and death by 50% in outpatients
BioSpace
OCTOBER 12, 2021
Investors are dropping dollars into the life sciences industry like the trees are dropping their leaves. Here’s who’s raking in the cash this week.
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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.
BioPharma Reporter
OCTOBER 12, 2021
Aceto expands GMP product lines for biopharmaceutical and vaccine manufacturing with acquisition of A&C Bio Buffer, growing its manufacturing footprint and strengthening its presence in Europe.
BioSpace
OCTOBER 12, 2021
?The FDA said that there had been concerns over the reduced effectiveness of the Moderna COVID-19 vaccine against symptomatic disease.
Outsourcing Pharma
OCTOBER 12, 2021
A leader from the division of Eli Lilly explains the importance of driving greater trial inclusivity, and why collaboration is vital in making progress.
BioSpace
OCTOBER 12, 2021
Research on the ever-evolving SARS-CoV-2 virus continues as scientists scramble to make sense of it and find cures. Here's a look.
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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 12, 2021
The US agency plans to use the software firmâs Lighthouse technology to improve understanding of COVID-19 and other conditions in long-term care facilities.
BioSpace
OCTOBER 12, 2021
The drug is limited to patients who test at least 20% for a Ki-67 score on an FDA-approved test.
ECRG Media's Clinical Research Podcast
OCTOBER 12, 2021
Senior CRA Details CRA Training Program 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 is a content creating
BioSpace
OCTOBER 12, 2021
Cue Health went public on September 24 on the Nasdaq securities exchange under the ticker symbol HLTH.
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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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