Drug Discovery World

JANUARY 27, 2023

The Winter 2022/2023 issue of Drug Discovery World Magazine is out now. Featuring a Therapeutic Spotlight on Oncology ,  the magazine is available to download free here and read for free on the DDW App. You can also request to receive a copy of the printed magazine here. Key features of the Winter issue include an overview of the drug discovery landscape in 2023, sector successes and challenges in the Scandinavian market, and how a drug sourced from the aerospace industry could offer treatments

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Drug Channels

JANUARY 17, 2023

Consolidation has brought together large, economically significant insurer/PBM/specialty pharmacy/provider organizations within U.S. drug channels. At least half of all U.S. healthcare spending flows through these seven familiar entities: Blue Cross Blue Shield, Centene, Cigna, CVS Health, Elevance Health, Humana, and United Health Group. In the brief video clip below, I review these businesses and offer some thoughts on their positioning for 2023.

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Antidote

JANUARY 12, 2023

Alzheimer’s disease is the most common type of dementia in the United States, impacting around 6.2 million people above the age of 65. Since it was first observed in the early 1900s, a lot of information has been uncovered through medical research.

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Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUMET Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two suppliers. There are four… The post New patent expiration for Merck Sharp drug JANUMET appeared first on DrugPatentWatch - Make Better Decisions.

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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.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

By Holly N. Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide infor

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The Premier Consulting Blog

JANUARY 31, 2023

On November 1, 2022, the U.S. Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). The guidance document and integrated addendum detail an integrative, weight-of-evidence (WoE) method of determining whether carcinogenicity testing in rats will be informative in human risk assessments for drug approvals.

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Drug Channels

JANUARY 13, 2023

Today’s guest post comes from Clay Courville, Chief Product Officer at CoverMyMeds. Clay discusses the ongoing problem of medication errors. He describes CoverMyMeds’ provider alerts solution, which is designed to minimize medication errors. Click here to learn more about CoverMyMeds’ Provider Medication Alerts solution. Read on for Clay’s insights.

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Antidote

JANUARY 17, 2023

Hemophilia is a disease in which the blood does not clot properly. It is rare and typically hereditary, often leading to spontaneous or excessive bleeding, especially following injuries or surgery, and internal bleeding can be a major risk factor. Below, we’re exploring a few hemophilia facts many people may not know.

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Drug Patent Watch

JANUARY 2, 2023

Annual Drug Patent Expirations for TOVIAZ Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent expiration for Pfizer drug TOVIAZ appeared first on DrugPatentWatch - Make Better Decisions.

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FDA Law Blog: Drug Discovery

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. This year’s conference co-chairs include Stacy Cline Amin (Partner, Morrison Forester) and Kurt 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.

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Cytel

JANUARY 31, 2023

Asthma affects more than 235 million people worldwide, and due to lacking effective implementation of clinical guidelines, there continue to be high rates of uncontrolled asthma. In order to evaluate differences in healthcare resource utilization and cost among patients with controlled and uncontrolled asthma in Germany, Cytel experts applied a unique approach: a linked data study comparing insurance claims data with primary data.

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Drug Discovery World

JANUARY 23, 2023

Over the three days of Advanced Therapies Week (ATW) 2023 in Miami, Florida, US, from 18 to 20 January, DDW’s Megan Thomas heard from attendees about what they were most looking forward to learning from the event, as well as why they think the potential of cell and gene therapies outweighs the obstacles that must be overcome to achieve it. Matt Lakelin, co-founder of TrakCel, shared that although ATW took place last year, 2023 sees the first fully subscribed ATW since the coronavirus pandemic.

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Drug Channels

JANUARY 10, 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. Each exclusion list now contains about 600 products. Growth in the number of excluded drugs slowed for the second year, due partly to the fact that so many drugs have already been dropped from PBMs’ formularies.

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Antidote

JANUARY 3, 2023

Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinical trial. Clinical trials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.

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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

Clinical Trials

Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three… The post New patent expiration for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.

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Reprocell

JANUARY 31, 2023

Fresh human tissue residual to surgical and diagnostic procedures is often discarded as waste or processed and prepared in a fixed or frozen state for long-term storage as part of a biobank collection. Some stored tissue may be compatible with, and distributed for use in, future investigations and studies, but for many, the donated tissue can remain in storage unused for years.

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BenchSci

JANUARY 31, 2023

Bringing new medicines and hope to patients faster all starts with preclinical research. But on average, a staggering 98 percent of all pharmaceutical research investment fails to reach patients. There’s a reason for this: biology is incredibly complex. Choosing the right targets, designing successful experiments, and identifying safety and efficacy risks, as just a few examples, involve hundreds or even thousands of trial-error processes and require scientists to work with a seemingly endless n

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Drug Discovery World

JANUARY 16, 2023

BioGrad, a company offering medical and scientific support for education and research organisations, is to open the UK’s second largest biobank facility in Liverpool, as part of a £7.6m investment into a new headquarters at Wavertree Technology Park. . In collaboration with the University of Leicester, BioGrad biobank has already welcomed up to 261,000 samples from the largest long-Covid study in the UK.

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Drug Channels

JANUARY 4, 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. For 2022, brand-name drugs’ net prices dropped for an unprecedented fifth consecutive year. What’s more, after adjusting for overall inflation, brand-name drug net prices plunged by almost 9%.

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Antidote

JANUARY 26, 2023

Osteoporosis, translated directly to “porous bone,” is a condition that impacts approximately 10 million Americans. The human body is constantly producing bone cells, but they are constantly being lost as well — and when the cells are being dissolved faster than they are being produced, weakness can result. Below, we’ll be taking a closer look at what osteoporosis is, what causes it, and how people can reduce the likelihood of developing the condition in their lifetime.

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Drug Patent Watch

JANUARY 25, 2023

Annual Drug Patent Expirations for JUVISYNC Juvisync is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are four patents protecting this drug and three… The post New patent expiration for Merck Sharp drug JUVISYNC appeared first on DrugPatentWatch - Make Better Decisions.

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Plenge Gen

JANUARY 28, 2023

For me, the most enjoyable aspect of discovery research is exploring the unknown. It is about having a big idea; believing in that big idea based on a scientific belief framework ; coming to a crossroads in the validity of the big idea, which is usually marked by deep uncertainty and skepticism; making a data-driven scientific decision to proceed (or not) to the next inflection point of testing the big idea; and ultimately arriving at a conclusion of whether the big idea is true.

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BenchSci

JANUARY 31, 2023

With the launch of ASCEND™ by BenchSci, we wanted to take the time to dive deeper into the story of how it came to be and the instrumental role one of our top customers played to help shape this revolutionary new technology platform for preclinical pharmaceutical research.

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Drug Discovery World

JANUARY 17, 2023

Oregon State University College of Pharmacy scientists have shown that lipid nanoparticles and messenger RNA could treat blindness associated with a rare genetic condition. . Researchers developed nanoparticles able to penetrate the neural retina and deliver mRNA to the photoreceptor cells whose proper function makes vision possible. . The study, led by OSU Associate Professor of Pharmaceutical Sciences Gaurav Sahay, Oregon State doctoral student Marco Herrera-Barrera, and Oregon Health &

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Drug Channels

JANUARY 27, 2023

Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment. Click here to learn about MMIT’s Contract Validation solution.

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Antidote

JANUARY 18, 2023

National Glaucoma Awareness Month is a campaign aimed at increasing awareness around glaucoma, a leading cause of vision loss and blindness with no early warning signs.

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Drug Patent Watch

JANUARY 30, 2023

Annual Drug Patent Expirations for ZYKADIA Zykadia is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eleven patents protecting… The post New patent expiration for Novartis drug ZYKADIA appeared first on DrugPatentWatch - Make Better Decisions.

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Cytel

JANUARY 27, 2023

Should your clinical trial be adaptive? Trials that include a prospectively planned modification based on an interim analysis, otherwise known as adaptive trials , are often associated with greater efficiency and better prospects for patients without compromising statistical rigor. And new holistic approaches to creating these designs are making room for transformative, even revolutionary, changes to strategic drug development.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. Nonetheless, there are some interesting facets to discover, a selection of which we take a look at in a two-part blog on “Metabolism of 2022 FDA approved small molecule drugs.” Analysis of the 100 most commonly prescribed dr

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Drug Discovery World

JANUARY 24, 2023

DDW Multimedia Editor Megan Thomas observes the 2023 drug discovery landscape, speaking to industry experts and looking at the foundations of 2022 on which next year will lean. Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords. The overall virtual clinical trials market is currently valued at $7.8 billion, with a projected growth of 14% per annum 1.

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Drug Channels

JANUARY 23, 2023

Informa Connect’s PAP – Patient Assistance & Access Programs | Part of Access USA Hybrid Event | March 20-22, 2023, Philadelphia Marriott Downtown www.informaconnect/pap Exclusive Offer – Be sure to use your exclusive promocode 23DCPAP10 to save 10% off* your registration. The last thing a patient should worry about is access to care. With growing demand for patient assistance, accelerating prescription access and affordability is as crucial as ever.

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Antidote

JANUARY 30, 2023

We’re always excited to get a chance to connect with people in the clinical trial industry, and this year, we’re thrilled to share that we’ll be attending SCOPE 2023 from February 6 to 9 in Orlando, Florida.

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Drug Patent Watch

JANUARY 30, 2023

Annual Drug Patent Expirations for DALVANCE Dalvance is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent for Allergan drug DALVANCE appeared first on DrugPatentWatch - Make Better Decisions.

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New Drug Approvals

JANUARY 25, 2023

Amcenestrant (SAR 439859) アムセネストラント Molecular Weight 554.48 Formula C 31 H 30 Cl 2 FNO 3 CAS No. 2114339-57-8 6-(2,4-dichlorophenyl)-5-[4-[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxyphenyl]-8,9-dihydro-7 H -benzo[7]annulene-2-carboxylic acid Amcenestrant 8-(2,4-dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro – 5H- Benzo[7]annulene-3-carboxylic acid 8-(2,4-Dichlorophenyl)-9-(4-{[(3 S )-1-(3-fluoropropyl)pyrrolidin-3-yl]oxy}phenyl)-6,7-dihydro-5 H -be

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