Drug Discovery World
MARCH 31, 2023
Today is #WearAHatDay created by Brain Tumour Research to raise awareness and funds for research into finding treatments for brain cancer. Brain Tumour Research encourages people to “look super for science and help research breakthroughs happen” Over the last ten years, Wear A Hat Day events have raised more than £2 million to help fund research and raise awareness of brain tumours.
Chemical Biology and Drug Design
MARCH 28, 2023
In this study, 255 drug targets of metformin were obtained from the BATMAN, Drugbank, PharmMapper, SwissTargetPrediction, and TargetNet databases. Meanwhile, 10,463 differentially expressed genes (DEGs) in OC were screened from GSE29450, GSE10971, GSE18520, GSE14407, and TCGA + GTEx datasets. A total of 95 common targets were obtained by deintersection of drug targets of metformin and DEGs in OC.
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FDA Law Blog: Biosimilars
MARCH 29, 2023
By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n
Antidote
MARCH 29, 2023
The annual Kidney Action Week is a virtual event put on by the American Kidney Fund designed to bring the entire kidney health community together for a week of amazing and informative content on all things related to kidney health. The event is filled with discussions, Q&As, webinars, and more — and this year, Antidote was thrilled to be involved!
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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 Discovery World
MARCH 31, 2023
News round-up for 27-31 March by DDW Digital Content Editor Diana Spencer. As March draws to a close, this week’s key announcements have demonstrated the breadth of international approaches to tackling cancer, with vaccines, proenzymes, immunotherapies and antibody-based treatments all currently under investigation around the world. The top stories: Drug discovery partners from UK and Japan target macrophages Macomics and Ono Pharmaceutical have entered a worldwide drug discovery
Drug Channels
MARCH 28, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Antidote
MARCH 27, 2023
Each year in March, the National Institute of Diabetes and Digestive and Kidney Diseases puts on National Kidney Month , a month dedicated to raising awareness about kidney health and conditions. Chronic kidney disease, a grouping of conditions that damage the kidneys , impacts around 37 million Americans, and millions of others are considered to be at an increased risk.
Drug Discovery World
MARCH 31, 2023
Clinical trial technology platform Inato, based in Paris, France, has closed a $20 million Series A funding from investors including Cathay Innovation, Obvious Ventures, La Maison and Top Harvest Capital. With the new funding, Inato will advance its diversity product offering to meet the new FDA requirements. The company will also invest in oncology-specific innovation to increase access to treatments where enrolment rates remain low.
Drug Channels
MARCH 27, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Friday's webinar will include my latest thoughts on a key trend discussed in todays rerun: how plan sponsors are incorporating patient-paid prescriptions—cash-pay prescriptions and discount cards—within pharmacy benefits.
FDA Law Blog: Biosimilars
MARCH 30, 2023
By Larry K. Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? Maybe you identify and report suspicious orders or thefts/losses. Or you obtain import or export permits, submit import or export declarations or listed chemical DEA-486s. Do you want to learn more? You have your chance. DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical r
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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.
Drug Patent Watch
MARCH 31, 2023
Annual Drug Patent Expirations for VANCOMYCIN Vancomycin is a drug marketed by Xellia Pharms Aps, Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Alkem… The post New patent for Xellia Pharms drug VANCOMYCIN appeared first on DrugPatentWatch - Make Better Decisions.
Drug Discovery World
MARCH 31, 2023
The US Food and Drug Administration (FDA) has granted Fast Track Designation to RRx-001 for the prevention/attenuation of severe oral mucositis in chemotherapy and radiation-treated head and neck cancer patients. The FDA also accepted the company’s Investigational New Drug (IND) application to initiate a follow-on Phase IIb clinical trial, called KEVLARx, in the same head and neck cancer patient population.
Drug Channels
MARCH 29, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. One follow-up to this rerun: Kroger’s participation as a preferred pharmacy declined significantly due to its Express Scripts relationship. Based on early 2023 enrollment data, Kroger is preferred in plans that enrolled only 11.8 million people—a decline of 33% from the 2022 figure.
BenchSci
MARCH 31, 2023
As Women’s History Month comes to a close, I wanted to share some of the events and takeaways we learned on behalf of the BenchShe+ leadership team. We had the honor of putting together programming not just for members of the BenchShe+ employee resource group (ERG), but also hosting events company-wide to help educate and inspire our team throughout the month.
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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
Advarra
MARCH 31, 2023
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.
Drug Discovery World
MARCH 30, 2023
Likang Life Sciences has been granted implied approval by China’s National Medical Products Administration (NMPA) for the clinical trial of its innovative personalised neoantigen-targeted vaccine LK101 Injection for advanced solid tumours. This breakthrough marks the first of its kind in China and represents a significant milestone in innovative drug discovery pathways for cancer treatment.
Drug Channels
MARCH 31, 2023
This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. Time for the Drug Channels annual reality check on drug pricing. The data once again tell a different story than you might read in your favorite politician’s Twitter feed or misleading news reports.
Drug Patent Watch
MARCH 30, 2023
Annual Drug Patent Expirations for ISENTRESS Isentress is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from eight suppliers. There are six… The post New patent for Msd Sub drug ISENTRESS appeared first on DrugPatentWatch - Make Better Decisions.
Crucial Data Solutions
MARCH 30, 2023
In a time with lots of hype surrounding decentralized clinical trial (DCT) solutions, let's not lose sight of the importance of a dependable and secure electronic data capture (EDC) system. This blog post walks you through the basics to keep in mind when selecting an EDC platform for your studies. The post Electronic Data Capture – The Basics appeared first on Crucial Data Solutions.
Drug Discovery World
MARCH 30, 2023
Astellas Pharma and MIMETAS, which specialises in human disease modelling, have entered a strategic partnership to develop treatments for cancer. The companies will use MIMETAS’ tumour models to support the next generation of immuno-oncological therapies. “We are excited to make this next step in our longstanding collaboration with Astellas,” Paul Vulto, CEO of MIMETAS, said.
Drug Channels
MARCH 30, 2023
This week, I’m rerunning some popular posts while I prepare for tomorrow’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. So far, it appears that PBMs are neither preferring Amgen's Humira biosimilar nor embracing the low-list/low-rebate version. In February, AbbVie stated that U.S. Humira sales would be decline by about 37% in 2023—which is at the lower end of its previous erosion projection of 35% to 55%.
Drug Patent Watch
MARCH 30, 2023
Annual Drug Patent Expirations for AUVI-Q Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. It is available from two suppliers. There are thirty patents… The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.
ACTO
MARCH 30, 2023
Listen on In this episode, Marie-Josee Toutounji, Medical affairs professional with over 20 years of experience in the pharmaceutical industry, discusses the pressing issue of unapproved content in the medical and regulatory field. The episode covers the potential risks of using unapproved content and tools in healthcare. Marie-Josee explores the challenges of implementing a continuous learning culture in the industry, with a focus on stakeholder engagement, compliance, and documentation to deve
Drug Discovery World
MARCH 30, 2023
This is the latest episode of the free DDW podcast, “Painting a picture of the lab of the future”. It covers two articles written for the exclusive DDW & SLAS2022 supplement published in Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “ Perspective: education and lab automation ” and “ The lab of the future is now ”. In the first article, Joshua Kangas, an educator in the Computational Biology Department of Carnegie Mellon University who is helping to shape the minds of future la
Crucial Data Solutions
MARCH 30, 2023
With all of the critical data that needs to be collected over the course of a clinical trial, one might assume that all of this data must be collected and managed electronically. Yet, this is not the case. While most clinical researchers have embraced the use of specialized software platforms to help stay on top of study data, there are still some who continue to collect, store, access and analyze data using old-school pen and paper or with software (like spreadsheets) that are not fit for purpo
Drug Patent Watch
MARCH 30, 2023
Annual Drug Patent Expirations for EVZIO Evzio is a drug marketed by Kaleo Inc and is included in two NDAs. There are thirty-three patents protecting this drug. Drug patent litigation… The post New patent for Kaleo Inc drug EVZIO appeared first on DrugPatentWatch - Make Better Decisions.
Predictive Oncology
MARCH 28, 2023
Predictive Oncology announces it is partnering with Integra Therapeutics, a company focused on engineering the next generation of gene writing tools to cure diseases. The collaboration was created to pursue a novel method to enhance Integra Therapeutics’ ability to use gene editing for future cancer therapies. Read about the news here. The post Predictive Oncology announces collaboration to advance gene therapy appeared first on Predictive Oncology.
Drug Discovery World
MARCH 30, 2023
Salipro Biotech, in collaboration with AstraZeneca, has published data from a study which describes a novel method to directly extract membrane proteins from cells into lipid Salipro nanoparticles, enabling structure-function analysis using surface plasmon resonance (SPR) and cryo-electron microscopy (cryo-EM) for challenging drug targets. The scientists extracted and purified functional membrane proteins directly from cells using the membrane protein PANX1 as a case study.
H1 Blog
MARCH 28, 2023
The United States devotes roughly $200 billion to national health expenditures on medical devices every year. In fact, the global medical devices market is projected to grow from $495.46 billion in 2022 to $718.92 billion by 2029. Medical device companies historically have operated under the assumption that if they built it, physicians would buy it.
Drug Patent Watch
MARCH 30, 2023
Annual Drug Patent Expirations for ISENTRESS+HD Isentress Hd is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from eight suppliers. There are… The post New patent for Msd Sub drug ISENTRESS HD appeared first on DrugPatentWatch - Make Better Decisions.
The ChEMBL-og
MARCH 28, 2023
The drug warning information in ChEMBL has been updated for version 32. In particular, the withdrawn drug data has been fully reviewed and, to assist the manual curation process, our rules have been updated, clarified and formally written. In ChEMBL, a withdrawn drug is an approved drug (ie Phase 4) that has subsequently been withdrawn for toxicity reasons.
Drug Discovery World
MARCH 30, 2023
This is the latest episode of the free DDW podcast, “Painting a picture of the lab of the future”. It covers two articles written for the exclusive DDW & SLAS2022 supplement published in Volume 23, Issue 1 – Winter 2021/22 of DDW. They are called “ Perspective: education and lab automation ” and “ The lab of the future is now ”. In the first article, Joshua Kangas, an educator in the Computational Biology Department of Carnegie Mellon University who is helping to shape the minds of future la
Advarra
MARCH 28, 2023
The Food and Drug Administration’s (FDA’s) proposed single institutional review board (sIRB) mandates are in part designed to support greater efficiencies and consistencies when conducting multisite research. This change has the potential for a substantial impact on sponsors and contract research organizations (CROs), as well as institutions conducting multisite research.
Drug Patent Watch
MARCH 30, 2023
Annual Drug Patent Expirations for EVZIO+%28AUTOINJECTOR%29 Evzio (autoinjector) is a drug marketed by Kaleo Inc and is included in one NDA. It is available from one supplier. There are thirty-two… The post New patent for Kaleo Inc drug EVZIO (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.
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