Drug Discovery Today

APRIL 24, 2023

(MIAMI) Researchers at the John P. Hussman Institute for Human Genomics at the University of Miami Miller School of Medicine have found that variations in chromatin accessibility, and thus gene expression, may explain why people of European descent with APOE4 gene variants have a greater risk of developing Alzheimer’s disease than people of African descent with similar genetics.

Disease 201

Disease Research 201

Drug Hunter

APRIL 23, 2023

There were plenty of scientific highlights from the literature that we didn’t have space for in Molecules of the Month – here’s a reader’s digest rounding up ~20 molecules of potential interest that we didn’t have space to highlight, including Pfizer’s covalent heterobifunctional BTK degrader, BMS’ brain-penetrant GSK-3β inhibitor, the discovery story of futibatinib from Taiho, and more snippets to jumpstart your reading!

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Forbes: Drug Truths

APRIL 6, 2023

Clearly, Canada would find such a situation untenable and the steps now being taken by British Columbia for Ozempic would be adopted across Canada.

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Chemical Biology and Drug Design

APRIL 28, 2023

Geraniol (GE) by its antioxidant, anti-inflammatory, and anti-apoptotic properties ameliorated global ischemia-reperfusion induced cascade of events such as oxidative stress, apoptosis, and inflammation. Thus, improved functional outcomes, and prevented neuronal infarction in rats. Abstract Geraniol (GE), an acyclic monoterpene, is a chief constituent of essential oils of herbs and fruits.

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Treatment Research 100

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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

ASPET

APRIL 27, 2023

In situ clinical measurement of receptor occupancy (RO) is challenging, particularly for solid tumors, necessitating the use of mathematical models that predict tumor receptor occupancy to guide dose decisions. A potency metric, average free tissue target to initial target ratio (AFTIR), was previously described based on a mechanistic compartmental model, and is informative for near-saturating dose regimens.

Drugs 100

Drugs Pharmaceuticals 100

FDA Law Blog: Biosimilars

APRIL 25, 2023

By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”? A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” If a device uses software that connects to the internet, it is most likely a cyber device and subject to new section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.

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Drug Hunter

APRIL 20, 2023

We asked the global drug discovery community to nominate and vote on their favorite molecule from 2022, and the results are in. The 2022 winner, with the most overall votes across the ten finalist molecules , is BMS’ oral, deuterated allosteric TYK2 inhibitor, deucravacitinib, the first new treatment for plaque psoriasis in nearly a decade. Here, we highlight what makes deucravacitinib so impressive to the drug discovery community.

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ProRelix Research

APRIL 27, 2023

Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other drug-related problems.” […] The post Pharmacovigilance Services for Signal Management: Process as per US FDA appeared first on ProRelix Research.

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Chemical Biology and Drug Design

APRIL 28, 2023

The key virulence factors like Kinetoplastid Membrane Protein–11 (KMP-11), Leishmanolysin (GP63), Proteophosphoglycan (PPG), Lipophosphoglycan (LPG), Glycosylinositol Phospholipids (GIPL), and others that play a role in the pathogenicity-host-pathogen relationship of the parasite. Abstract In tropical and subtropical regions of the world, leishmaniasis is endemic and causes a range of clinical symptoms in people, from severe tegumentary forms (such as cutaneous, mucocutaneous, and diffuse leishm

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Antidote

APRIL 26, 2023

For individuals and companies that write health-focused blogs, continually finding topics to cover can be a challenge at times. Whether you’re a health influencer, patient advocacy organization, or another player in the clinical trial industry, finding unique topics to differentiate a blog is not always easy. However, through the below ideas and a unique voice, it is possible to write a plethora of clinical trial blogs that stick out from the rest.

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Clinical Trials Trials 98

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Clinical Trials

Drug Channels

APRIL 12, 2023

In Drug Channels Institute’s list of the top 15 pharmacies of 2022 , we show that central-fill, mail pharmacies operated by large PBMs and health insurers have displaced retail chains as the largest prescription drug dispensers by revenues. To complement that broader ranking, we rummaged around our DreamHouse to update our exclusive list of the top 15 pharmacies based on specialty drug dispensing revenues in 2022.

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Drug Discovery Today

APRIL 14, 2023

Through a series of exclusive interviews and a survey of industry insiders, Connect in Pharma names the top pharmaceutical and manufacturing-related trends of 2023

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Drug Target Review

APRIL 26, 2023

Scientists from the Massachusetts Institute of Technology (MIT) and the University of Massachusetts Medical School (UMass), US, have collaborated to create a novel type of nanoparticle that can deliver messenger RNA that encodes for beneficial proteins to the lungs. Gene-editing methods allow researchers to modify DNA, resulting in alterations in physical characteristics such as eye colour and susceptibility to diseases.

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ProRelix Research

APRIL 5, 2023

Clinical trials form the decisions for regulatory approval of drugs and medical devices and as a result are the most important step of a drug development program. In addition to […] The post Investigator Initiated Trials (IITs): Introduction, regulatory view, study design preferences, and p … appeared first on ProRelix Research.

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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

Chemical Biology and Drug Design

APRIL 29, 2023

MYC regulates main genes of exosome biogenesis in breast cancer. Furthermore, MYC regulates oncogenic roles of breast cancer cells-derived exosomes in breast cancer and MYC-expressing cancer cells-secreted exosomes induce higher cellular activity of recipient cells in breast cancer. Abstract MYC amplification and overexpression in breast cancer occur 16% and 22%, respectively, and MYC has a linchpin role in breast carcinogenesis.

Regulations 100

Regulations Research 100

Antidote

APRIL 17, 2023

Homocystinuria, an inherited disorder, is a rare metabolic condition that impacts 1 in 335,000 people worldwide and is present from birth. Often abbreviated as HCU or HCY, homocystinuria is a genetic disorder that inhibits the body from processing certain amino acids found in proteins, causing a harmful buildup of homocysteine and methionine.

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Drug Channels

APRIL 28, 2023

Today’s guest post comes from Megan Marchal, Director of Specialty Strategy at CoverMyMeds. Megan shares the story of Don, a cancer patient who struggled to access and afford his medications. She describes how human care plus an innovative, technology-driven patient support solution can help patients start therapy and get on the road to recovery. To learn more about CoverMyMeds’ specialty therapy solutions , visit Booth 1519 at Asembia's Specialty Pharmacy Summit in Las Vegas, April 30-May 4

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Drug Discovery Today

APRIL 27, 2023

3DSecret funded by European Innovation Council’s Pathfinder Open 2022, established under the EU Horizon Europe program.

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Eye on FDA

APRIL 28, 2023

In today’s Federal Register , the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range of topics, including an assessment of terms and phrases commonly used in prescription drug promotion, studying the comprehension and understanding of multiple indications used in consumer television advertisements, and endorser status and explicit

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Drug Patent Watch

APRIL 13, 2023

Annual Drug Patent Expirations for ZOSYN+IN+PLASTIC+CONTAINER Zosyn In Plastic Container is a drug marketed by Wyeth Pharms and is included in one NDA. It is available from two suppliers. There… The post New patent expiration for Wyeth Pharms drug ZOSYN IN PLASTIC CONTAINER appeared first on DrugPatentWatch - Make Better Decisions.

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Chemical Biology and Drug Design

APRIL 27, 2023

Explainable artificial intelligence transparently influences the pre-drug development process with SHAP and LIME annotation methods. Abstract Recently, artificial intelligence (AI) techniques have been increasingly used to overcome the challenges in drug discovery. Although traditional AI techniques generally have high accuracy rates, there may be difficulties in explaining the decision process and patterns.

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Drugs Drug Development 100

Antidote

APRIL 12, 2023

Every April is National Minority Health Month , organized by the U.S. Department of Health and Human Services. This month is intended to highlight the focus on improving the health of racial and ethnic minorities by reducing health disparities and increasing equal access to care.

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Drug Channels

APRIL 7, 2023

Today’s guest post comes from Heather Roulston, Market Research Manager at MMIT. Using MMIT’s proprietary data, Heather demonstrates that contracting for medical benefit drugs is now common for many therapeutic areas. She then highlights how manufacturers and payers are adopting value-based agreements (VBA) for medical benefit products—although VBA usage varies widely across therapeutic area.

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Drug Discovery Today

APRIL 18, 2023

The home of the UK’s lab industry expands floor plan to accommodate increased interest in this year’s show

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NIOSH Science Blog: Drugs

APRIL 12, 2023

In November 2022, the American Journal of Industrial Medicine (AJIM) published a special issue focusing on work-related fatigue. The issue explores factors that may increase work-related fatigue and actions to reduce work-related injuries and illnesses. [1] This issue is a result of discussions and collaborations from the 2019 NIOSH Working Hours, Sleep and Fatigue Forum and also pulls from reports by the National Institute for Occupational Safety and Health (NIOSH) on long work hours and shift

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Drug Patent Watch

APRIL 30, 2023

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

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Chemical Biology and Drug Design

APRIL 27, 2023

Synergistic combinations of inhibitors are sought after. A small helically-constrained peptide potently inhibited p53-HDM2 interaction and exerted anti-proliferative effects on p53 +/+ cells. A combination of this peptide and a USP7 inhibitor showed synergistic anti-proliferative effects. Synergistic inhibition of two important drug targets may lead to novel therapeutic strategies.

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Regulations Drugs Research 100

Antidote

APRIL 6, 2023

At any given time, there are hundreds of thousands of research studies listed on ClinicalTrials.gov actively looking for patients both in the United States and across the globe. However, the multitude of options available does not necessarily mean it’s easy for interested individuals to find opportunities they are eligible for. That’s why we created Antidote Match™, a clinical trial search tool that allows users to answer a few questions about their health and find clinical trial listings that c

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Clinical Trials Trials Research 98

Drug Channels

APRIL 14, 2023

Today’s guest post comes from Edward Hensley, Chief Commercial Officer at AssistRx. Edward discusses how a technology-first approach automates manual processes for therapy initiation. He argues that such an approach can increase patient adherence, speed access to therapy, and improve the healthcare providers’ workflow. To learn about AssistRx’s technology-first solutions, click here to schedule a meeting at Asembia’s Specialty Pharmacy Summit.

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Drug Discovery Today

APRIL 21, 2023

Domainex is honoured to announce it has received a King’s Award for Enterprise: International Trade 2023.

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NIOSH Science Blog: Drugs

APRIL 4, 2023

Struck-By Injuries Struck-by injuries occur from violent contact or impact between an object or piece of equipment and a person. Struck-by injuries can be fatal, and even when a worker is not seriously injured can result in days off work to recover. To help prevent struck-by injuries, companies are encouraged to have a stand-down; a voluntary event for employers to talk directly to employees about safety.

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Drug Patent Watch

APRIL 19, 2023

This article was originally published by Jiayi Chen, Zhifeng Zhao, Xinyu Wang and Jingjun Huang in Drug Repurposing – Advances, Scopes and Opportunities in Drug Discovery and is republished here… The post Utilizing 505(b)(2) Regulatory Pathway for New Drug Applications: An Overview on the Advanced Formulation Approach and Challenges appeared first on DrugPatentWatch - Make Better Decisions.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

By Kurt R. Karst & Michael D. Shumsky — On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 1067, the “ Ensuring Timely Access to Generics Act of 2023 ,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights i

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Antidote

APRIL 24, 2023

Eosinophilic esophagitis, also known as EoE, is a rare condition estimated to affect just one in 2,000 individuals. It is a disorder that impacts the esophagus (the tube connecting the mouth to the stomach) and leads to swallowing difficulties in both children and adults. To learn more about the impact of eosinophilic esophagitis , check out the information below.

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