Antidote

FEBRUARY 24, 2023

While breast cancer is often thought of as a singular diagnosis, it is actually an umbrella term that encompasses several subtypes of the disease — many of which have been discovered in recent years due to continual advancement in the oncology research space. Traditionally, breast cancers are grouped into subtypes according to the Tumor, Nodes, and Metastasis system of staging breast cancer, the reproductive status of the patient, and the types of biological markers that are found in the cancer

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Drug Channels

FEBRUARY 24, 2023

Today’s guest post comes from Matt Hall, President of Patient Solutions at CareMetx. Matt shares three key findings from CareMetx’s exclusive new survey on patient support services for specialty pharmaceuticals. To learn more, download CareMetx’s free 2022 Report - Patient Services Trends. Read on for Matt’s insights. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Pharmaceuticals Drugs 98

Cytel

FEBRUARY 24, 2023

Last week, Cytel Director & Research Principal Louis Dron discussed new FDA guidance on the design and conduct of trials incorporating an external control group, sometimes known as a synthetic control arm. But what are synthetic control arms and what are the potential benefits to this clinical trial design?

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Clinical Trials FDA Trials Research 52

DS in Pharmatics

FEBRUARY 24, 2023

Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Specialist regulatory affairs consultants offer services to companies operating across this challenging industry. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market.

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Pharmaceutical Companies Regulations Drug Development Pharmaceuticals 52

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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.

Clinical Trials

Antidote

FEBRUARY 21, 2023

Did you know that February is American Heart Month ? This month is dedicated to raising awareness for and providing education on heart health, high blood pressure, and cardiovascular disease.

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Disease 98

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. This report—our fourteenth edition—remains the most comprehensive, fact-based tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system. 12 chapters, 480+ pages, 241 exhibits, 900+ endnotes: There is nothing else available that comes close to this valuable resource.

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Pharmacy Specialty Pharmacies Licensing Licensing 97

DS in Pharmatics

FEBRUARY 24, 2023

Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments.

Treatment 52

Treatment Disease 52

Antidote

FEBRUARY 22, 2023

When sponsors advertise a clinical trial online, they will typically either provide sites with individual advertising budgets or work with a clinical trial recruitment company to create outreach materials. Once created, these materials will undergo the IRB approval process and then be distributed across online channels such as Facebook and Google Ads.

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Clinical Trials Trials 96

Tecan

FEBRUARY 24, 2023

By Adrian Cortes Sanchon Collaboration is the cornerstone of innovation. An ongoing collaboration between Tecan, manufacturer of robust, high-quality liquid handling automation systems, its partner, Macherey-Nagel, developer of nucleic acid extraction kits, and their customer, a research group from Jülich Research Center, in Germany, is proving to create fertile ground for innovation and sustainable solutions.

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Research 52

Advarra

FEBRUARY 24, 2023

How do you know your experimental therapy is working? Sometimes, it can be as simple to determine as comparing drug A to placebo and measuring the physiological result with an approved assay. But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex.

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Clinical Trials Trials FDA Therapies 52

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Clinical Trials

Drug Patent Watch

FEBRUARY 23, 2023

Annual Drug Patent Expirations for FOTIVDA Fotivda is a drug marketed by Aveo Pharms and is included in one NDA. It is available from one supplier. There are three patents… The post New patent for Aveo Pharms drug FOTIVDA appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Cytel

FEBRUARY 22, 2023

Simulation-guided design is quickly becoming a novel feature of modern drug development. Its foundational promise is to harness the power of data to create robust trial strategy. With high-compute power and incredible speed, decision-makers can now create strategy that de-risks clinical trials while offering necessary flexibility when challenges arise, and clarity to align on goals.

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Clinical Trials Trials Drug Development Drugs 52

NIOSH Science Blog: Drugs

FEBRUARY 22, 2023

Surveillance is the cornerstone of public health practice, including in occupational safety and health (OSH). OSH surveillance systems have the ability to generate data that drives decision making and action.1, 2 There are multiple steps in a surveillance system including timely and accurate data collection; data quality monitoring; data management; data analysis; interpretation of results; and dissemination and application of information.1 OSH researchers have used surveillance systems to impro

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Research 52

Translation

FEBRUARY 21, 2023

Working with universities can bring tremendous benefits to a company. Access to cutting-edge research drives innovation and accelerates the development of new products and technologies. Navigating the often-complex world of academic partnerships can be challenging, however, and a crucial aspect of funded research is often overlooked – indirect costs.

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Research Production 52

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Clinical Trials

Drug Patent Watch

FEBRUARY 22, 2023

Annual Drug Patent Expirations for AKYNZEO Akynzeo is a drug marketed by Helsinn Hlthcare and is included in two NDAs. It is available from one supplier. There are nineteen patents… The post New patent for Helsinn Hlthcare drug AKYNZEO appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

PPD

FEBRUARY 22, 2023

The past year was difficult financially, particularly in the biotech industry. Funding dried up after a period of rapid investing that pushed capital allocators further up the risk curve. A number of investments during this time may also have been motivated by the fear of missing out. These anecdotal struggles were highlighted in industry research conducted by PPD, the clinical research business of Thermo Fisher Scientific.

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Clinical Research Biosimilars Marketing Trials 52

BenchSci

FEBRUARY 22, 2023

This week we’re spotlighting Omotola Komaiya , a Product Analyst on our Analytics team. Omotola shares below more about her career journey in science and then tech, how our Analytics team plays an important role in building products for our customers, and the best party she has ever thrown! Read on to learn more.

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Pharmacy Science Production 52

The Open Targets Blog

FEBRUARY 22, 2023

The latest release of the Platform — 23.02 — is now available at platform.opentargets.org. Key points In addition to regular updates from our data providers, we have a number of new features in this release. New evidence for target-disease associations Additional data for metabolic biomarkers added to our Gene Burden widget QTL-based direction of effect included in evidence from Open Targets Genetics Improved target annotation data Integration of Target safety evidence from AOPWiki

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Disease Production Regulations Drugs 52

Drug Patent Watch

FEBRUARY 22, 2023

Annual Drug Patent Expirations for QVAR+REDIHALER Qvar Redihaler is a drug marketed by Norton Waterford and is included in one NDA. It is available from one supplier. There are ten… The post New patent for Norton Waterford drug QVAR REDIHALER appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. With so many important discussions happening this year between stakeholders, it is impossible to be a part of them all.

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Disease Clinical Trials Trials Treatment 52

Reprocell

FEBRUARY 21, 2023

The motilin receptor is a heterotrimeric G-protein-coupled receptor (GPCR38) involved with regulating stomach motility. 1,2 Since its discovery in 1999 researchers have been keen to develop compounds that can modify this receptor. 3 In this article, we will explore everything that is known about its function, physiology, and pharmacology.

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Regulations Research Drugs 52

Elrig

FEBRUARY 23, 2023

Synthetic biology, the answer to ageing, and more at Research & Innovation 2023 Synthetic biology, the answer to ageing, and more at Research & Innovation 2023 The life sciences and drug discovery landscape continues to advance at pace, delivering innovations with the potential to transform patients’ lives across the world. But keeping up with these advancements is no easy feat.

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Research Disease Science Drugs 40

Drug Patent Watch

FEBRUARY 21, 2023

Annual Drug Patent Expirations for SAXENDA Saxenda is a drug marketed by Novo and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting… The post New patent expiration for NOVO drug SAXENDA appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Channels

FEBRUARY 22, 2023

Is the gold rush in copay accumulators and maximizers slowing down? Our latest update finds that for 2022, about 40% of commercial lives have adopted these benefit designs. Accumulator adoption has plateaued, while maximizer use has overtaken accumulators. Patients who take a single-source, brand-name specialty drug for autoimmune conditions, multiple sclerosis, and oncology increasingly face these benefit designs.

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Drugs 98

Molecular Design

FEBRUARY 22, 2023

<< previous | I’ll wrap up (at least for now) the series of posts on chemical probes by returning to the use of cheminformatic models for assessment of the suitability of compounds for use as chemical probes. My view is that there is currently no cheminformatic model, at least in the public domain, that is usefully predictive of the suitability (or unsuitability) of compounds for use as chemical probes and that assessments should therefore be based exclusively on experimental measurements

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Science Research 40

Drug & Device Law

FEBRUARY 20, 2023

In updating chapter three of his book , on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim.

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FDA FDA Approval Testimonials Vaccine 59

Drug Patent Watch

FEBRUARY 21, 2023

Annual Drug Patent Expirations for VICTOZA Victoza is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from two suppliers. There are seven… The post New patent expiration for Novo Nordisk drug VICTOZA appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 21, 2023

Annual Drug Patent Expirations for XELSTRYM Xelstrym is a drug marketed by Noven Pharms Inc and is included in one NDA. It is available from one supplier. There are five… The post New patent for Noven Pharms drug XELSTRYM appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 21, 2023

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

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 20, 2023

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

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 20, 2023

Annual Drug Patent Expirations for TRICOR Tricor is a drug marketed by Abbvie and Abbvie Inc and is included in three NDAs. It is available from six suppliers. There are… The post New patent expiration for Abbvie drug TRICOR appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 20, 2023

Annual Drug Patent Expirations for ZECUITY Zecuity is a drug marketed by Teva Branded Pharm and is included in one NDA. There are ten patents protecting this drug. This drug… The post New patent expiration for Teva Branded drug ZECUITY appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 19, 2023

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

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Drugs Marketing 52

Drug Patent Watch

FEBRUARY 18, 2023

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

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