Mon.Dec 11, 2023

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New DDW Highlights episode out now

Drug Discovery World

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. The news highlights this week are mostly focused around neuroscience, with new guiding principles and a drug repurposing fund launched for motor neuron disease research, a new drug target found for early-onset dementia, and a possibly game-changing schizophrenia drug entering human tria

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Progress of SARS?CoV?2 Main protease peptide?like inhibitors

Chemical Biology and Drug Design

The paper reviews the structure and peptide-like inhibitors of SARS-CoV-2 M pro , also the binding mode and structure—activity relationship between the inhibitors and M pro are introduced in detail. It is hoped that this review can provide ideas and help for the development of anti-coronavirus drugs such as COVID-19, and help to develop broad-spectrum antiviral drug for the treatment of coronavirus diseases as soon as possible.

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Naobios receives $1.87 million in support of vaccine development 

Drug Discovery World

Naobios, a CDMO providing bioprocess development and GMP production of clinical batches of virus-based products, has received a $1.87 million grant from the Bill & Melinda Gates Foundation in support of vaccine development. Naobios will manufacture a human viral challenge agent that will be used to evaluate the effectiveness of vaccines in preventing infections and to accelerate the vaccine development process.

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Humira leads ICER’s latest list of ‘unsupported’ price hikes

BioPharma Drive: Drug Pricing

AbbVie’s blockbuster medicine topped a list of treatments that, combined, elevated U.S. healthcare spending by $1.3 billion in 2022, according to the price watchdog’s latest yearly report.

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How Machine Learning Drives Clinical Trial Efficiency

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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Potential breakthrough in treatment of urea associated skin diseases

Drug Discovery World

MC2 Therapeutics has completed enrolment in its Phase II MC2-25 Ph2 chronic kidney disease-associated pruritus trial, with topline results expected in Q2 2024. MC2-25 CKD is a first-in-class drug candidate and could represent a potential breakthrough in the understanding and treatment of urea associated skin diseases. Chronic kidney disease-associated pruritus (CKD-aP) is a debilitating condition thought to affect a significant proportion of the ~800 million people globally who suffer from CKD s

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Brain Serotonin Levels May Play Role in Alzheimer's Onset

Drugs.com

MONDAY, Dec. 11, 2023 -- Loss of the “happiness” brain hormone serotonin might play a role in the decline of brain function as a person ages, a new study reports.People with mild cognitive impairment (MCI) had up to 25% lower levels of.

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More Trending

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Avoiding 'Wine Teeth' at Those Holiday Parties

Drugs.com

MONDAY, Dec. 11, 2023 -- The holidays are all about parties, and parties are all about drinking wine. But if you're a red wine lover, how do you avoid stained teeth?“When you drink red wine, you’re encountering a triple threat to your teeth’s.

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FDA approves first gene therapies for sickle cell disease (with a warning)

Drug Discovery World

The US Food and Drug Administration (FDA) has approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD), Casgevy and Lyfgenia. Casgevy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is also the first FDA-approved treatment to use CRISPR gene editing technology. However, the FDA added a black box warning for Lyfgenia due to the risk of blood cancer in these patients, which resulted in the value of stocks in Bluebird Bio dropping steeply since the approval

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Stay Safe and Warm This Holiday Season Like Frosty the Worker

NIOSH Science Blog: Drugs

♪ Frosty the Worker, Is a jolly happy soul, With his big warm boots and his warm-up breaks, The cold cannot take its toll. ❄ ♪Hypothermia and chilblains, May be fairy tales one day, Cuz’ with training and prevention, Frostbite can be kept at bay.❄ ♪It really isn’t magic when, A warm wool hat is worn, For with proper gear there is no fear, When an employer plan is formed.❄ ♪Oh, Frosty the Worker, We’ll keep you warm when you’re outside, Take breaks and layer your clothing, And we’re sure that you

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ASH23: Pharma branding, Editas’ high bar and clinical trial diversity

BioPharma Drive: Drug Pricing

Editas had the tall task Monday of convincing ASH attendees its gene therapy for sickle cell disease could improve on Casgevy and Lyfgenia.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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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CDC Warns of Deadly Tick-Borne Illness in People Traveling to Mexico

Drugs.com

MONDAY, Dec. 11, 2023 -- An outbreak of deadly tick-borne disease is occurring among people who’ve recently been to Baja California in Mexico, the U.S. Centers for Disease Control and Prevention warns. Three out of five patients have died.

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Researchers compare mental illness, gun violence rates in U.S., Australia and U.K.

SCIENMAG: Medicine & Health

Considerable attention has focused on mental illness as a major contributor to homicides in the United States. Serious mental illness affects more than 14 million Americans ages 18 and older and nearly 58 million people reported having a mental illness.

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You're Far Less Likely to Get an Opioid Now After Surgery

Drugs.com

MONDAY, Dec. 11, 2023 -- In response to the ongoing crisis of opioid misuse, U.S. doctors had already cut the amount of opioids they gave patients after surgery by 2022 to just a third of the amount given in 2016, new research shows.Much of the.

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UC San Diego Health completes acquisition of Alvarado Hospital Medical Center

SCIENMAG: Medicine & Health

On December 11, 2023, UC San Diego Health successfully completed the purchase of Alvarado Hospital Medical Center from Prime Healthcare. The acquisition of the 302-bed medical facility greatly expands the university’s growing network of clinics and hospitals to better serve patients with safe, timely and equitable access to high-quality health care.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Black Patients Less Likely to Get Home Health Care After Hospital Discharge

Drugs.com

MONDAY, Dec. 11, 2023 -- Nurses are less likely to discharge still-recovering Black patients to home health care than white patients, a new study has found.About 22% of Black patients are referred to home health care by discharge nurses, compared.

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Revolutionary AI-enhanced model predicts wheat health across diverse soils using drone data

SCIENMAG: Medicine & Health

In agricultural and remote sensing research, accurately estimating wheat’s Leaf Area Index (LAI) using unmanned aerial vehicle-based multispectral data is essential for monitoring crop health and growth. Traditionally, LAI measurement is accurate but laborious. Recent advancements have introduced hybrid methods combining radiative transfer models with machine learning, showing promise due to their efficiency and applicability.

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Recorded Webinar: FAIR (meta)-Data & Assay Annotation

Collaborative Drug

Explore key insights from the Pistoia Alliance's FAIR Data & Assay Annotation webinar. Discover the latest in bioassay data management and standardization.

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McGovern Medical School names new neurosurgery chair; Tandon takes on role at UTHealth Houston Neurosciences

SCIENMAG: Medicine & Health

Jacques Morcos, MD, a renowned neurosurgeon from University of Miami Health System, will join UTHealth Houston as the new chair of the Vivian L. Smith Department of Neurosurgery with McGovern Medical School at UTHealth Houston, effective today.

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Extremely rare bird captured on film

Science Daily: Pharmacology News

A striking and extremely rare half-female, half-male bird has been spotted by a zoologist.

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Stem cell study reveals how infantile cystinosis causes kidney failure – and how to cure it

SCIENMAG: Medicine & Health

BUFFALO, N.Y. – University at Buffalo research has identified how a misstep in the genesis of a key component of the kidney causes infantile cystinosis, a rare disease that significantly shortens the lifespan of patients. Published Nov.

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Swift Use of Antiretrovirals in Infected Newborns Can Banish HIV

Drugs.com

MONDAY, Dec. 11, 2023 -- When an HIV-infected child known as the 'Mississippi baby' was given powerful antiretroviral drugs within hours of birth in 2013 and then appeared to be rid of HIV, people wondered if it might be replicated in other.

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Study reveals a protein called snail may play a role in healing brain injury

SCIENMAG: Medicine & Health

WASHINGTON (Dec. 11, 2023)–A new study published in Proceedings of the National Academy of Sciences Nexus provides a better understanding of how the brain responds to injuries. Researchers at the George Washington University discovered that a protein called Snail plays a key role in coordinating the response of brain cells after an injury.

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What’s Behind CVS Health’s Novel Vertical Integration Strategy for Humira Biosimilars (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from September 2023. One update: CVS Caremark's 2024 formulary for patient-administered autoimmune products prefers: Humira Hyrimoz (the high WAC Sandoz biosimilar) adalimumab-adaz (the unbranded, low WAC Sandoz biosimilar) Perhaps coincidentally, Sandoz products are marketed by Cordavis, the new business described in today's rerun.

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New patent for TEVA drug AUSTEDO XR

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO+XR Austedo Xr is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are nine patents… The post New patent for TEVA drug AUSTEDO XR appeared first on DrugPatentWatch - Make Better Decisions.

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The FDA and oncology: 2023 year in review

Agency IQ

As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. Read on for a deep dive into the major themes in oncology this past year.

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Profitable growth is on the horizon

BioPharma Drive: Drug Pricing

A return to profitable growth is on the horizon—organizations that take advantage of the following key trends can thrive in 2024 and beyond.

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Profiling nuclear cysteine ligandability and effects on nuclear localization using proximity labeling-coupled chemoproteomics

Covalent Modifiers

Qianni Peng, Eranthie Weerapana Cell Chemical Biology , 2023 DOI: [link] The nucleus controls cell growth and division through coordinated interactions between nuclear proteins and chromatin. Mutations that impair nuclear protein association with chromatin are implicated in numerous diseases. Covalent ligands are a promising strategy to pharmacologically target nuclear proteins, such as transcription factors, which lack ordered small-molecule binding pockets.

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Life sciences leaders invest in process mining to accelerate digital transformation

BioPharma Drive: Drug Pricing

Research from Everest Group shows how life sciences leaders are investing in process mining to speed time-to-market, improve regulatory compliance and drive innovation.

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New patent for Boehringer Ingelheim drug PRADAXA

Drug Patent Watch

Annual Drug Patent Expirations for PRADAXA Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from four suppliers. There are four patents… The post New patent for Boehringer Ingelheim drug PRADAXA appeared first on DrugPatentWatch - Make Better Decisions.

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Cities are dropping out of a major PFAS settlement. What are the ramifications?

Agency IQ

A variety of cities and municipalities have rejected a proposed settlement with several producers of per- and polyfluoroalkyl substances. This AgencyIQ analysis reviews some of the reasons that the cities and municipalities have rejected the settlement, and what could be next for PFAS litigation in the United States. Fill out the form to read the full article.

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New patent for Kaleo Inc drug AUVI-Q

Drug Patent Watch

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 three suppliers. There are thirty-one patents… The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.

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Quality Control: What is really in your hiPSC culture?

Reprocell

Finding a suitable human iPSC (hiPSCs) line is the first step of many disease modeling and cell therapy projects. Once a suitable donor has been found and hiPSCs have been generated, certain quality control (QC) measures of the cell culture to verify its identity and quality are crucial. If portions of the QC are missing or deviate from the standard, the results acquired with these cells may be unusable or may produce misleading conclusions.

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New patent for Teva Branded drug AUSTEDO

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and Teva and is included in two NDAs. It is available from one supplier. There… The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

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Navigating the Challenges in Clinical Research for Hepatitis C Therapies

Vial

Hepatitis C virus (HCV) infection is a global health problem with complications that place a significant economic burden on national health systems. Pathophysiological evidence links HCV infections to the risk of liver diseases such as hepatocellular carcinoma (HCC) and liver cirrhosis. HCV infections are particularly challenging due to their chronicity and quasispecies nature.