Drug Discovery World
SEPTEMBER 22, 2022
A new bioreactor platform that aims to support the cell and gene therapy (CGT) sector from process development to commercial manufacturing has been launched. The Quantum Flex Cell Expansion System has been created by medical technology company Terumo Blood and Cell Technologies (Terumo BCT). Using the system, developers can complete early process development on the same platform as manufacturing.
Drug Discovery Today
SEPTEMBER 9, 2022
On the 26th-27th of October, Vilnius is hosting the European Forum for Industrial Biotechnology & the Bioeconomy 2022 (EFIB'22). The forum will bring together business leaders, entrepreneurs, scientists, and investors as one of Europe's most meaningful events for biotechnology. We caught up with the Executive Director of the Lithuanian Biotechnology Association, Agne Vaitkeviciene, who told us about the importance of the forum and the potential of the Lithuanian life sciences sector.
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Antidote
SEPTEMBER 30, 2022
Since 1999, October has been recognized as Health Literacy Month. The goal, as defined by the Institute for Healthcare Advancement , is to raise awareness about the importance of understandable health information — but what is health literacy and why is it important?
Drug Channels
SEPTEMBER 16, 2022
Today’s guest post comes from Edward Hensley, Chief Commercial Officer at AssistRx. Edward compares the pros and cons of electronic benefit verification using artificial intelligence, direct connectivity, or data connectivity. He also describes the circumstances where each solution provides the greatest value. To learn more, download AssistRx’s free eBook: Specialty Drug Patient Support Programs: 2022 Progress Report.
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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.
Drug Patent Watch
SEPTEMBER 24, 2022
Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.
Eye on FDA
SEPTEMBER 28, 2022
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same old focus – direct-to-consumer advertising (DTC). First, just a note on why the research is of importance at all.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Drug Discovery Today
SEPTEMBER 8, 2022
Collaboration expands Lonza’s end-to-end offering for mRNA manufacturing with additional, differentiated source of DNA raw material, Touchlight’s doggybone DNA (dbDNATM). Touchlight provides synthetic DNA through a cell-free enzymatic process, with advantages of speed, quality, capacity, and scalability.
Antidote
SEPTEMBER 12, 2022
There are many factors one should consider before deciding to enroll in a clinical trial. Though every clinical trial is designed to help researchers advance their knowledge about a specific condition, the details regarding a study’s duration, risks, benefits, and required time commitment can vary. When determining how to participate in clinical trials, these elements are all good things to discuss with the research team to determine if a study is a good fit.
Drug Channels
SEPTEMBER 7, 2022
As regular readers know, the biosimilar boom for provider-administered drugs has been accelerating. Prices are dropping while adoption accelerates. In many therapeutic areas, biosimilars’ market share is approaching 80%. In the video below, I review these developments and discuss lessons from the launch of Semglee, the first interchangeable insulin.
Drug Patent Watch
SEPTEMBER 7, 2022
This is a guest post by Oleksandr Topachevskyi at Digital Health Outcomes. Oleksandr may be contacted at sales@digitalho.com Commercial, nonprofit, and government companies are quite good at calculating the costs…. The post Social Return on Investment appeared first on DrugPatentWatch - Make Better Decisions.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Advarra
SEPTEMBER 29, 2022
Informed consent is one of the central protections the regulations provide to research subjects. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs). The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study. Note: Individual institutional review boards (IRBs) may have their own specific policies regarding how ICFs should be formatted, how to address certain regulatory criteri
Drug Discovery World
SEPTEMBER 2, 2022
A recent study by the University of Colorado School of Medicine shows that diabetes drug metformin is effective for preventing severe illness from Covid-19. The CU School of Medicine was part of a multi-site clinical trial into the effectiveness of metformin, ivermectin and fluvoxamine in non-hospitalised adults with Covid-19. . The study, which launched in January 2021, included those who were vaccinated and those who were not, as well as people who were pregnant.
Drug Discovery Today
SEPTEMBER 16, 2022
Why opening up communication channels can stop the spread of misinformation
Antidote
SEPTEMBER 5, 2022
Because Hunter syndrome is a rare, inherited disorder that mostly impacts children, it can lead to many questions from the parents and caregivers of those that are affected.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Drug Channels
SEPTEMBER 9, 2022
Today’s guest post comes from Kristina Crockett, Vice President of Product Management at CoverMyMeds. Kristina discusses the affordability challenges that patients face in our complex and confusing healthcare system. She then explains how data and technology can help payers, manufacturers, and providers improve medication access. To learn more about CoverMyMeds’ comprehensive affordability solutions, download Overcoming Medication Affordability Challenges with Patient-Centered Solutions.
Drug Patent Watch
SEPTEMBER 29, 2022
Annual Drug Patent Expirations for LUMAKRAS Lumakras is a drug marketed by Amgen Inc and is included in one NDA. It is available from one supplier. There are two patents…. The post New patent for Amgen Inc drug LUMAKRAS appeared first on DrugPatentWatch - Make Better Decisions.
NIH Director's Blog: Drug Development
SEPTEMBER 27, 2022
Wearable electronic sensors hold tremendous promise for improving human health and wellness. That promise already runs the gamut from real-time monitoring of blood pressure and abnormal heart rhythms to measuring alcohol consumption and even administering vaccines. Now a new study published in the journal Science Advances [1] demonstrates the promise of wearables also extends to the laboratory.
Drug Discovery World
SEPTEMBER 30, 2022
In this listicle, SAMDITech outlines the benefits of outsourcing models in the pharmaceutical industry, looking past perceived costs to the value outsourcing can bring. . Many biotech and pharmaceutical companies now rely on contract research organisations (CROs) for drug discovery services. CROs offer an established infrastructure to develop, initiate, execute, and progress drug discovery programs towards the clinic.
National Institute on Drug Abuse: Nora's Blog
SEPTEMBER 27, 2022
Supporting Needed Research on Recovery mfleming Tue, 09/27/2022 - 13:33 Nora's Blog September 28, 2022 National Recovery Month (Recovery Month), which started in 1989, is a national observance held every September to promote and support new evidence-based treatment and recovery practices, the nation’s strong and proud recovery community, and the dedication of service providers and communities who make recovery in all its forms possible.
Antidote
SEPTEMBER 21, 2022
September 21 is World Alzheimer’s Day , a day of recognition aimed at increasing awareness of and understanding the issues faced by people living with Alzheimer’s. Though there are many conditions that can cause memory loss , Alzheimer’s is one of the most common — it is estimated that 5.4 million Americans are living with the condition , most of whom are over the age of 65.
Drug Channels
SEPTEMBER 20, 2022
On October 11, 2022, Drug Channels Institute will release The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. This report—our thirteenth edition— remains the most comprehensive, fact-based tool for understanding and analyzing the large and growing U.S. pharmaceutical distribution industry. We are providing you with the opportunity to preorder this thoroughly updated and revised 2022-23 edition at special discounted prices.
Drug Patent Watch
SEPTEMBER 29, 2022
Annual Drug Patent Expirations for NOCTIVA Noctiva is a drug marketed by Serenity Pharms Llc and is included in one NDA. There are two patents protecting this drug. Drug patent…. The post New patent for Serenity Pharms drug NOCTIVA appeared first on DrugPatentWatch - Make Better Decisions.
Advarra
SEPTEMBER 23, 2022
The Food and Drug Administration (FDA) is the federal entity in the U.S. charged with (among other things) “ensur[ing] that safe and effective drugs are available to improve the health of the people in the United States.” . Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine : .
Drug Discovery World
SEPTEMBER 30, 2022
New trial data has shown that using a patient’s own immune cells could be a powerful immunotherapy for metastatic melanoma, an aggressive skin cancer. . The TIL (tumour-infiltrating lymphocytes) trial compared T cell therapy to standard immunotherapy with the checkpoint inhibitor ipilimumab. . The results of the trial were presented at the 2022 annual congress of the European Society for Medical Oncology (ESMO) in Paris. .
Olympian Clinical Research
SEPTEMBER 22, 2022
It is estimated that about 14% of the population will experience onychomycosis, more commonly known as toenail fungus, at some point in their lives. Toenail fungus may affect people of all ages, but it is more common in adults over 60. Furthermore, it can quickly spread to other toenails if left untreated. This all-inclusive guide will teach you everything you need to know about toenail fungus, from identifying the symptoms to exploring treatment options.
Antidote
SEPTEMBER 7, 2022
Strong clinical trial recruitment strategies start from a place of patient centricity, incorporating a variety of outreach methods designed to educate and engage potential participants. Creating a structured clinical trial patient recruitment plan before outreach begins is a smart way to ensure that the process is organized, efficient, and keeps the patient experience as the top priority.
Drug Channels
SEPTEMBER 23, 2022
Today’s guest post comes from Lindsey Alves, Vice President of Customer Success at Kalderos. Lindsey describes the challenges facing remote workers who manage government-managed drug discount programs. As she explains, all drug discount stakeholders require novel technology-enabled collaboration tools. To learn more, register for Kalderos’ panel discussion, The Dreaded Duplicate Discounts: Collaborating in the New Hybrid Working Landscape.
Drug Patent Watch
SEPTEMBER 28, 2022
Annual Drug Patent Expirations for CLARINEX+D+24+HOUR Clarinex D 24 Hour is a drug marketed by Organon and is included in one NDA. There are two patents protecting this drug. This…. The post New patent expiration for Organon drug CLARINEX D 24 HOUR appeared first on DrugPatentWatch - Make Better Decisions.
ProRelix Research
SEPTEMBER 21, 2022
According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, with a death rate of one in six in 2020 (1). Aside from the high […]. The post Cancer Clinical Trials: USA Scenario and Study Designs appeared first on ProRelix Research.
Drug Discovery World
SEPTEMBER 30, 2022
ELRIG CEO Sanj Kumar tells readers how they can access the most exciting research and find the latest technologies to propel their projects forward at this year’s Drug Discovery 2022 . At ELRIG, our purpose is to support researchers in the life sciences and drug discovery communities to learn, share, innovate, connect, and collaborate. We understand that you find it difficult to keep up with the latest research and technological developments across the industry, from cell and gene therapy advanc
Translation
SEPTEMBER 19, 2022
Like most startups, Halo looks much different today than it did when we started, but the problem we’re solving hasn’t changed — there are thousands of scientific discoveries that never materialize into real-world solutions. At first, we tried to solve this problem by crowdfunding research projects to help leapfrog these nascent technologies over the so-called “valley of death.
Antidote
SEPTEMBER 29, 2022
Though it has only been identified since the early 1990s, Eosinophilic Esophagitis (EoE) has come to be known as a major cause of gastrointestinal illness. Though there are still a lot of unknowns surrounding EoE, ongoing research hopes to provide patients and medical professionals with more insights in the future.
Drug Channels
SEPTEMBER 21, 2022
The battle for control of the specialty patient continues. In 2022, specialty pharmacies—via white, brown, and clear bagging—now constitute a meaningful share of the distribution channels for provider-administered oncology drugs. However, buy-and-bill appears to have rebounded substantially at hospitals. As I explain below, this resurgence likely reflects the success of vertically-integrated hospital/specialty pharmacy/physician mega-systems against the large insurer/PBM/specialty pharmacy/provi
Drug Patent Watch
SEPTEMBER 28, 2022
Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty…. The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.
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