Fri.Nov 10, 2023

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Molecular photoswitch improves visual acuity in retinitis pigmentosa

Drug Discovery World

Topline results from a Phase I/II clinical trial have shown that Kiora’s light-restoring small molecule KIO-301 has the potential to meaningfully improve vision in patients with retinitis pigmentosa (RP). The results of the ABACUS study for Kiora’s intravitreal (IVT) molecular photoswitch were presented at the American Academy of Ophthalmology annual conference by Russell Van Gelder, Professor and Chair, Department of Ophthalmology, University of Washington, School of Medicine.

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Designing cities for 21st-century weather

Science Daily: Pharmacology News

Researchers have investigated how changes in urban land and population will affect future populations' exposures to weather extremes under climate conditions at the end of the 21st century. They used a data-driven model to predict how urban areas across the country will grow by 2100, and found that how a city is laid out or organized spatially has the potential to reduce population exposures to future weather extremes.

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This week in drug discovery (6-10 November) 

Drug Discovery World

News round-up for 6-10 November by DDW Digital Content Editor Diana Spencer. With the first DDW Turning Science into Business Summit taking place next week on the theme of Cancer Research, this dynamic area of drug discovery is my round-up focus again. Most significantly, this week has seen the UK approval of a new indication for anastrozole in the prevention of breast cancer and a number of significant findings in the field of immunotherapy announced at SITC 2023.

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Blood Clot Risk From Contraceptive Pills Ends Soon After Women Stop Taking Them

Drugs.com

FRIDAY, Nov. 10, 2023 -- Women and their doctors have long known that taking birth control pills can elevate the risk for a blood clot. Now, some good news: That added risk will disappear within a few weeks of stopping an oral contraceptive, a new.

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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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Latest advances in immunotherapy from SITC 2023

Drug Discovery World

The Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting (SITC 2023) took place on 1-5 November 2023, at San Diego Convention Center in San Diego, US. CAN-2409 in non-metastatic pancreatic cancer Candel Therapeutics reported on initial positive interim data from its Phase II clinical trial of CAN-2409 that showed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC).

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Low-intensity fires reduce wildfire risk by 60%, according to study by Columbia and Stanford researchers

Science Daily: Pharmacology News

High-intensity, often catastrophic, wildfires have become increasingly frequent across the Western U.S. Researchers quantified the value of managed low-intensity burning to dramatically reduce the risk of such fires for years at a time.

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Childhood Vaccine Exemptons Hit Highest Level Yet: CDC

Drugs.com

FRIDAY, Nov. 10, 2023 (Healthday News) -- In a sign that suggests many American parents have become dubious about the safety of childhood vaccines, new government data shows that immunization exemptions for kindergartners have reached their highest.

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Four Trends That Are Shaping the Future of Market Access

Drug Channels

Today’s guest post comes from James Pisano, Partner, Market Access at The Dedham Group and Dinesh Kabaleeswaran, SVP of Insights & Advisory Teams at MMIT. James and Dinesh offer four trends that they predict will shape medication access in the coming years. Click here to learn about consulting services from MMIT and its sister company The Dedham Group.

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Major Study Confirms CT Scans' Link to Blood Cancer Risk in Kids

Drugs.com

FRIDAY, Nov. 10, 2023 -- CT scans are significantly linked to an increased risk of blood cancers in young people, a major multinational study has found. Analysis of data from nearly 1 million people under 22 who underwent at least one CT scan found.

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Scientists found hundreds of toxic chemicals in recycled plastics

Science Daily: Pharmacology News

When scientists examined pellets from recycled plastic collected in 13 countries they found hundreds of toxic chemicals, including pesticides and pharmaceuticals. Because of this, the scientists judge recycled plastics unfit for most purposes and a hinder in the attempts to create a circular economy.

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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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Babies Are Contracting Salmonella After Handling Pet Food, FDA Warns

Drugs.com

FRIDAY, Nov. 10, 2023 (Healthday News) -- Two federal health agencies are investigating a salmonella outbreak linked to dog food that has sickened seven people in seven states, nearly all of them infants. On Thursday, the U.S. Food and Drug.

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A comprehensive evaluation of spontaneous pelvic organ prolapse in non-human primate as an ideal model for human prolapse studies

SCIENMAG: Medicine & Health

This study is led by Prof. Lan Zhu (Department of Obstetrics and Gynecology, Peking Union Medical College Hospital), Prof. Tao Tan (State Key Laboratory of Primate Biomedical Research, Kunming University of Science and Technology), and Prof. Weizhi Ji (State Key Laboratory of Primate Biomedical Research, Kunming University of Science and Technology).

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Science Reveals Link Between Obesity, Diabetes & Pancreatic Cancer Risk

Drugs.com

FRIDAY, Nov. 10, 2023 -- Having high insulin levels may be more than tough to manage when you have diabetes: New research shows it also appears to raise the risk of pancreatic cancer. In the study, scientists found excessive insulin levels.

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Yucatán's underwater caves host diverse microbial communities

Science Daily: Pharmacology News

With help from an experienced underwater cave-diving team, researchers have constructed the most complete map to date of the microbial communities living in the submerged labyrinths beneath Mexico's Yucatán Peninsula. Researchers found the cave system's microbiome is distinct from the nearby sea, and microbial communities vary between cave systems forming distinct 'neighborhoods.

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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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How Much Vision Loss Impairs Your Driving? New Study Has Answers

Drugs.com

FRIDAY, Nov. 10, 2023 -- A Mr. Magoo with thick glasses peering out from behind the wheel might not inspire confidence from his fellow motorists, but a new study shows other types of vision loss might be even more dangerous while driving. Loss of.

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CAR-T biotech Cargo Therapeutics prices $281M IPO

BioPharma Drive: Drug Pricing

Cargo Therapeutics is the seventh oncology biotech to successfully price an IPO this year.

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Black Patients With Early-Stage Colon Cancer Get Worse Care Than Whites: Study

Drugs.com

FRIDAY, Nov. 10, 2023 (HealthDay) -- Rates of colon cancer among relatively young Americans continue to rise, and a new study suggests that a patient's race might determine the quality of cancer care they receive. Being a Black patient appeared.

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New tentative approval for Rising drug acetylcysteine

Drug Patent Watch

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen,… The post New tentative approval for Rising drug acetylcysteine appeared first on DrugPatentWatch - Make Better Decisions.

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GPCR signaling contributes to immune characteristics of the microenvironment and the process of EBV-induced lymphomagenesis

SCIENMAG: Medicine & Health

This study is led by Prof. Wei-Li Zhao (Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine). Credit: ©Science China Press This study is led by Prof.

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3 Considerations of the Patient Perspective from the 2023 Pain Therapeutics Summit

Conversations in Drug Development Trends

Pain for chronic patients is not merely a condition they must manage but a social dynamic with various feelings and opinions. Its psychological impact is often understated, though it carries the same weight as pain’s physical effects. At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomar

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1 in 8 U.S. Military Families Now Resorting to Food Banks, Study Finds

Drugs.com

FRIDAY, Nov. 10, 2023 -- About one in eight military families are turning to food banks and community pantries to make ends meet and feed their children, a new study finds. More than 13% of military families with at least one child said they used a.

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Conduct of IDMCs for Cell and Gene Therapy Trials

Cytel

Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated sponsor liaisons. Characteristics of cell and gene therapy trials often require slightly different approaches to IDMC conduct in comparison to typical pivotal trials. Here I will discuss the conduct of IDMCs for cell and gene therapy trials.

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FDA delays enforcement of cosmetic product listing and facility registration, issues finalized guidance

Agency IQ

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA. The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.

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Perficient and the American Cancer Society Make Strides to End Breast Cancer

Perficient: Drug Development

October is Breast Cancer Awareness Month, which supports a global campaign to raise awareness and support for the women and men who are affected by this disease. Whether you are a survivor, newly diagnosed, or know a loved one with breast cancer, having a supportive community that encourages conversation and hope is valuable. We’re proud to partner with the American Cancer Society , a nationally recognized leader in breast cancer research and its Making Strides movement.

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Novo takes aim at obesity drug shortages with $6B manufacturing plan

BioPharma Drive: Drug Pricing

The maker of Wegovy and Ozempic plans to expand production in its home country of Denmark to help meet surging demand for the GLP-1 drugs.

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CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Agency IQ

The Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ), a super office charged with evaluating the quality of investigational and marketed drugs and biologics, is being reorganized in January 2024 into a new structure in a bid to address ongoing “pain points,” CDER Director Patrizia Cavazzoni wrote in an email to FDA staff today.

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Americans Are Now Getting Far Fewer Opioids for Dental Pain

Drugs.com

FRIDAY, Nov. 10, 2023 – If you’re getting a tooth pulled or having another painful dental procedure, you’re much less likely to get opioids than you were just a few years ago, new research reveals. That’s good news because.

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What you need to know about the status of the proposed EMA fees regulation

Agency IQ

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation. The still-pending agreement seems likely to soon be adopted, which would trigger an application date of January 1, 2025.

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Valneva’s chikungunya vaccine approved by FDA

BioPharma Drive: Drug Pricing

The preventive shot is the first to receive regulatory approval for the mosquito-borne illness, which is growing in prevalence worldwide.

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Wisconsin DNR finds PFAS in 71% of shallow groundwater samples

Agency IQ

The Wisconsin Department of Natural Resources has released the results of a study reviewing PFAS concentrations in 450 samples from shallow private wells. The study detected PFAS in 71% of the samples, with certain samples exceeding the Environmental Protection Agency’s proposed maximum contaminant levels for certain substances. Fill out the form to read the full article.

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Punishment for Drug Offenses in Russia

Common Sense for Drug Policy Blog

Punishment for Drug Offenses in Russia "Anti-drug legislation. 95% of all drug crimes registered in Russia in 2013–2014 were prosecuted under articles 228 and 228.1 of its Criminal Code. The severity of a penalty under these articles depends on the type of drug offense (drug use or drug sale) and on the weight of the drug seized, which are classified via threshold quantities as “significant”, “large” or “especially large” ( Appendix B , Tables B2 and B3 ).

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My Military Experience Was a Springboard to Career Success

Conversations in Drug Development Trends

As someone who joined the military right after high school, I can say that it was one of the best decisions I ever made. My nearly perfect score on the Armed Services Vocational Aptitude Battery Test (ASVAB) qualified me for three positions, and I ended up taking the one that required a top-secret/SCI security clearance – as a Record Telecommunications Center Operator.

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Transaction Accounts: Analyzing Deposit Stickiness in the Current Interest Rate Environment

Perficient: Drug Development

Retail banks respond to the Federal Reserve’s short-term interest rate adjustments with corresponding changes in lending and deposit rates. However, in the current rising interest rate environment in the United States since 2022, loan rates have adapted more rapidly than deposit rates. Sir Isaac Newtown’s first law of motion, which states that an object in motion will stay in motion and an object at rest will stay at rest unless acted upon by an external force, can be applied to retail depositor

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Creating patient-centric outreach materials for clinical trial patient recruitment [Antidote 2023 survey data]

Antidote

In 2018, we partnered with SCORR Marketing to conduct a survey aimed at gaining knowledge about the patient perception of clinical trial participation. We collected nearly 4,000 responses from individuals regarding what matters most to when considering a clinical trial.