Advarra

MARCH 10, 2023

Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African American population. Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.

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Drug Channels

MARCH 8, 2023

Next week, Drug Channels Institute will release our 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 14th edition of our popular and comprehensive examination of the entire U.S. drug pricing, reimbursement, and dispensing system. The exhibit below—one of 241 in our new report—provides a first look at the 15 largest organizations, ranked by total U.S. prescription dispensing revenues for calendar year 2022.

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Pharmacy Specialty Pharmacies Marketing Drugs 86

Drug Patent Watch

MARCH 4, 2023

This chart shows the drugs with the most patents in Ukraine. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Ukraine? appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceuticals Drugs 78

Eye on FDA

MARCH 5, 2023

In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the outcomes were increasingly negative. Just to recap, for the entire year of 2022 there were only 14 meetings held to consider whether new medicines should be recommended for approval, a slight increase over the 10 the year before, but considerably lower fewer than 2018

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FDA Vaccine Drugs Therapies 72

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Treatment

NIOSH Science Blog: Drugs

MARCH 6, 2023

The construction sector includes a diverse population of workers exposed to many different types of hazards. An important way to prevent occupational illness and injury related to these hazards is by implementing the hierarchy of controls. Personal protective equipment (PPE) is the last control in the hierarchy, but PPE is particularly important when the other controls cannot sufficiently reduce or eliminate hazards.

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Drug Channels

MARCH 7, 2023

Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook This event will be broadcast live on Friday, March 31, 2023, from 12:00 p.m. to 1:30 p.m. ET. This page describes the event and explains how to purchase a registration.

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Pharmacy Drugs Marketing 82

FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March.

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Packaging FDA Production Regulations 57

Covalent Modifiers

MARCH 9, 2023

John C. Tran, Thomas Hunsaker, Christina Bell, Taylur P. Ma, Emily Chan, Pablo Saenz-Lopez Larrocha, Kelsey Homyk, Liling Liu, Hank La, Jialin Mao, Cecile C. de la Cruz, Kebing Yu, Maureen Beresini, William F. Forrest, Yang Xiao, Anne Jang, Natalia Samus, Nicholas Dupuis Stesco, Marija Mentinova, Stephane Parent, Gwenael Pottiez, Michael Schirm, Hans E.

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Analytical Chemistry Drugs Research 52

Drug Channels

MARCH 6, 2023

Informa Connect’s Drug Pricing Transparency Congress May 16-17, 2023 in Washington, DC Drug Channels readers can save 10% with code 23DRCH10 www.informaconnect.com/drug-pricing-transparency Join Informa Connect on May 16-17, 2023 in Washington, DC at the Drug Pricing Transparency Congress to stay on the pulse of federal and state reporting requirements, policy initiatives and strategic best practices for compliance.

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Drugs Compliance Science Government 82

Drug Patent Watch

MARCH 4, 2023

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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Advertisement

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.

Clinical Trials

FDA Law Blog: Biosimilars

MARCH 7, 2023

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — As we discussed in our prior post , the electronic Submission Template And Resource (eSTAR) template will take getting used to in terms of form. It is also going to take some getting used to in terms of process. As most in the device industry know, preparing a 510(k) is typically a collaborative process—with multiple functions, consultants, and levels of management often involved in its review and creation.

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FDA Regulations 57

BMG Labtech

MARCH 8, 2023

Metabolic pathways Cell metabolism encompasses different steps and sequences of molecular conversions. This coordinated series of biochemical reactions where the product of one conversion becomes the substrate for another reaction is known as metabolic pathways. In these pathways, molecules are transformed by a series of enzymes. Basic metabolism can be simplified to pathways focusing on the use of major nutrients such as glucose, amino acids and fatty acids which are fundamental for energy prod

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Drug Channels

MARCH 10, 2023

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey discusses digital hubs and the affordability advantages they offer both patients on specialty therapies and their health care providers. To learn more, click here to schedule a meeting with AssistRx at Asembia’s Specialty Pharmacy Summit on April 30 to May 4, 2023.

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Specialty Pharmacies Pharmacy Therapies Marketing 78

Drug Patent Watch

MARCH 10, 2023

Expiring drug patents are continuously driving innovation, as branded firms seek out new high-margin opportunities. Examining the patent expirations by year can indicate which pharmaceutical companies face the most peril… The post Drugs facing the most patent expirations this year appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Companies Drugs Pharmaceuticals 52

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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.

Clinical Trials

FDA Law Blog: Biosimilars

MARCH 9, 2023

By John W.M. Claud & Douglas B. Farquhar — The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the corporate compliance chart.

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Compliance FDA Government Regulations 52

New Drug Approvals

MARCH 9, 2023

Are you aware of any Chemical Database which offers one stop solution to the Sourcing, R&D and Business Development department? Explore Smartchem to Quickly find Suppliers (Procurement), Customers (BD) & Synthetic pathways (R&D) Is this the information you looking for? Evaluate SmartChem, lets schedule a demo. Try us once. You will use us for life.

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Antidote

MARCH 9, 2023

Parkinson’s disease, a neurodegenerative brain disorder, impacts 10 million people across the world. Most commonly associated with tremors or shaking, it is a condition that significantly affects a person’s quality of life, and as of now, has no known cause. Individuals diagnosed with Parkinson’s are empowered to focus primarily on symptom management, which is typically done through medication and lifestyle changes.

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Disease 52

Drug Patent Watch

MARCH 10, 2023

Annual Drug Patent Expirations for DYANAVEL+XR+10 Dyanavel Xr 10 is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There… The post New patent for Tris Pharma drug DYANAVEL XR 10 appeared first on DrugPatentWatch - Make Better Decisions.

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Advertisement

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

Clinical Trials

Cytel

MARCH 8, 2023

Real-world data has been increasingly used to answer questions related to the course, prognosis, and treatment of multiple sclerosis – yet each data source has its limitations, restricting the questions that can be addressed. Here is our solution.

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Research Treatment Clinical Development 52

On Medicine

MARCH 8, 2023

The POTION project The overall objective of POTION is to delve deeper into the understanding of how the sense of smell influences human social interaction. The project will investigate social interaction, combining new knowledge about the chemical composition of human social chemosignals with a new smell-based technology designed to drive social behavior.

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Treatment Trials Regulations Therapies 52

Labcorp Drug Development

MARCH 8, 2023

When it comes to discoveries in oncology, cancer patients can’t wait, which means neither can you. At Labcorp Preclinical Oncology, we understand there are many steps, phases and regulations to wade through to get to a lead drug candidate—all while time is of the utmost importance. We are excited to … The post Program management services are now offered as part of Labcorp’s Preclinical Oncology Services appeared first on Insights From Our Labs to Yours.

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Regulations Drugs 52

Drug Patent Watch

MARCH 10, 2023

Annual Drug Patent Expirations for DYANAVEL+XR Dyanavel Xr is a drug marketed by Tris Pharma Inc and is included in two NDAs. It is available from two suppliers. There are… The post New patent for Tris Pharma drug DYANAVEL XR appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

DrugBank

MARCH 8, 2023

DrugBank's deep pool of drug knowledge can be used for everything from AI in drug discovery to In Silico, Precision Medicine, and so much more. We’ve intentionally structured our knowledgebase and datasets as a means of delivering specific and empowering insights that are usable for the full range of our users. To make sure you're getting the most out of DrugBank we've created a series of Data Implementation Guides.

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Drugs 52

Cytel

MARCH 7, 2023

Grammati Sarri was recently interviewed by Inside Precision Medicine for “Improving Health Equity Starts with Real-World Evidence.” To read the interview, click here. Health inequalities are an enduring issue that can be exacerbated by clinical trial recruitment that does not reflect the heterogeneous patient groups most likely to use these technologies when approved in clinical practice.

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Clinical Trials Trials Research Clinical Development 52

Covalent Modifiers

MARCH 7, 2023

Rajaiah Pergu, Veronika M. Shoba, Santosh K. Chaudhary, Dhanushka N. P. Munkanatta Godage, Arghya Deb, Santanu Singha, Uttam Dhawa, Viktoriya Anokhina, Sameek Singh, Sachini U. Siriwardena, Amit Choudhary bioRxiv 2023.03.05.531183; doi: [link] Chimeric small molecules that induce post-translational modification (PTM) on a target protein by bringing it in proximity to a PTM-inducing enzyme are furnishing novel modalities to perturb protein function.

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Drug Patent Watch

MARCH 10, 2023

Annual Drug Patent Expirations for DYANAVEL+XR+5 Dyanavel Xr 5 is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There… The post New patent for Tris Pharma drug DYANAVEL XR 5 appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Sygnature Discovery

MARCH 7, 2023

Sygnature Discovery, the global integrated drug discovery company, has unveiled a new platform that facilitates the combinational high-throughput assembly and review of molecular degraders ( CHARMED ), in response to a sustained rise in demand for its multi-disciplinary expertise. What is the CHARMED platform? Developed in-house at Sygnature Discovery, CHARMED is a technology platform designed to accelerate and support early-stage targeted protein degradation (TPD) programmes.

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Targeted Protein Degradation DNA Engineering Drugs 52

Labcorp Drug Development

MARCH 7, 2023

March is National Kidney Month, and we at Labcorp are committed to improving the renal health of patients worldwide. The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the … The post Enabling better access to kidney disease trials appeared first on Insights From Our Labs to Yours.

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Trials Disease Clinical Research Research 52

Reprocell

MARCH 6, 2023

A recent law passed in the USA means that new drugs do not need to be tested on animals before human studies. With support from over 200 organizations, the "FDA Modernization Act 2.0" expands the range of models that can be used to test a compound before clinical trials. 1 Under this new law animal testing can still be used, but alternative testing methods now also represent a legitimate option.

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Drug Patent Watch

MARCH 10, 2023

Annual Drug Patent Expirations for DYANAVEL+XR+15 Dyanavel Xr 15 is a drug marketed by Tris Pharma Inc and is included in one NDA. It is available from one supplier. There… The post New patent for Tris Pharma drug DYANAVEL XR 15 appeared first on DrugPatentWatch - Make Better Decisions.

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The Open Targets Blog

MARCH 6, 2023

Last year we added a new data source to the Open Targets Platform: Gene Burden. This feature assesses the contribution of rare variation in all protein-coding genes to more common, complex traits. Open Targets Platform 22.04 has been released! The 22.04 release of the Open Targets Platform integrates new gene burden analyses, structural variants from ClinVar, DailyMed drug label text-mining evidence, an NLP classification of why clinical trials stopped, as well as new data from the Gene2Phenotyp

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Disease Clinical Trials DNA Research 52

BMG Labtech

MARCH 9, 2023

Mitochondrial toxicity can occur when drugs or diseases affect the mitochondria and prevent the proper production of energy. Read, how to measure it with plate readers.

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Production Disease Drugs Cell Biology 52

Zobio

MARCH 9, 2023

In person Over the past years Cambridge Healthtech Institute’s Annual Drug Discovery Chemistry has grown to one of the largest events for medicinal chemists working in pharma and biotech. Focused on discovery and optimization challenges of small molecule drug candidates, this event provides many exciting opportunities for scientists. ZoBio is therefore proud to actively participate.

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