Mon.Sep 11, 2023

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NY Times Gets It Wrong On Impact Of Price Controls On New Drugs

Forbes: Drug Truths

But, make no mistake – the IRA will have a major impact on biopharma R&D and, as a result, fewer important medicines will be available.

Drugs 274
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IChemE announces 2023 Global Awards finalists

Drug Discovery Today

Professional excellence, positive environmental impact, process safety and societal benefit are among the key qualities being celebrated by the Institution of Chemical Engineers (IChemE) as it announces the finalists for its 2023 Global Awards.

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The Inflation Reduction Act Will Lead To Fewer New Medicines

Forbes: Drug Truths

But, make no mistake – the IRA will have a major impact on biopharma R&D and, as a result, fewer important medicines will be available.

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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

BioPharma Drive: Drug Pricing

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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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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Bioengineered instrument reveals hidden cancer cells

Drug Target Review

Cancer cells can elude the body’s immune defences by manipulating a group of molecules known as mucins, which are typically helpful and widespread. Mucins are proteins covered in sugar that primarily protect the body against physical harm and pathogens. However, cancer cells exploit mucins to support their survival. While the concept of removing mucins from cancer cells seems promising, mucins are present in various forms on all mammalian cells.

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FDA approves updated COVID boosters from Pfizer, Moderna

BioPharma Drive: Drug Pricing

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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How to Ask the Right Questions at an Authority Meeting

Cytel

As a drug developer, you have to live with the answers and comments you get from regulatory authorities. Therefore, it’s essential that you choose your questions carefully and avoid questions you don’t need answers to.

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Red Cross Appeals for Donors During National Blood Shortage

Drugs.com

MONDAY, Sept. 11, 2023 -- The American Red Cross said Monday that it urgently needs blood donations because the national blood supply has dropped nearly 25% since early August. Back-to-back climate-related disasters have hampered blood collection.

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World Suicide Prevention Day 2023: the Lifeguard Pharmacy study

On Medicine

Background 5583 suicides were recorded in 2021 and about 1 in 5 people experience suicidal ideation (suicidal thoughts and plans) in their lifetimes. People who are suicidal find it hard to seek help. They may not know where to go or may doubt that anyone would understand. Stigma, feeling like a burden and, for men, pressure to conform to societal norms concerning masculinity, are also barriers.

Pharmacy 105
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Number 100

Perficient: Drug Development

I have been working at Perficient for almost 8 years. I have always enjoyed writing blogs and sharing my knowledge with others. This is my 100 th blog post! WOW! I can’t believe I finally made it! Come with me while I take a look back at 8 years worth of content. Series I write a lot of blog series. I like to focus on a topic and share everything I can about it.

Doctors 104
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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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Have Sleep Apnea? CPAP Machine May Help Save Your Life

Drugs.com

MONDAY, Sept. 11, 2023 -- Millions of people who suffer from sleep apnea go to bed at night with a motorized device called a CPAP machine. Now, two new studies confirm the treatment has significant benefits not just on quality of sleep, but also for.

Treatment 105
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Building resilience through a school-based intervention: Introducing the ReSET project

On Medicine

As adolescents, we have the challenge of navigating our complex social relationships alongside experiencing stronger emotions and feelings. Sometimes, our emotions and relationships can negatively impact on one another. For example, we might remember a time when we had a disagreement with a friend, how this made us feel upset, and how this affected our conversation with another person, such as a parent.

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Yet Another Mosquito-Borne Threat: The 'Jamestown Canyon Virus'

Drugs.com

MONDAY, Sept. 11, 2023 -- You've probably heard of West Nile virus, but mosquitoes spread various other illnesses, too, including the little-known Jamestown Canyon virus (JCV), which is garnering attention across the United States.

Virus 105
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Healthy lifestyle can help prevent depression -- and new research may explain why

Science Daily: Pharmacology News

A healthy lifestyle that involves moderate alcohol consumption, a healthy diet, regular physical activity, healthy sleep and frequent social connection, while avoiding smoking and too much sedentary behavior, reduces the risk of depression, new research has found.

Research 109
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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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Americans Who Are Deaf Can Now Use 988 Suicide Helpline

Drugs.com

MONDAY, Sept. 11, 2023 – The U.S. government’s 988 Suicide and Crisis Lifeline is expanding its reach to help more people. The crisis line has now launched services in American Sign Language (ASL) to help callers who are deaf or hard of.

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'Night owls' more likely than 'early birds' to develop diabetes

Science Daily: Pharmacology News

A new study has an important message for people who consider themselves night owls. Investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, found that people with later sleep and wake times had less healthy lifestyles and were at greater risk of developing diabetes than those with early-bird sleep habits.

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Could Wildfire Smoke Raise Rural Suicide Rates?

Drugs.com

MONDAY, Sept. 11, 2023 -- As this summer has shown, the massive smoke plumes generated by wildfires can dirty the air of regions many miles away. Now a new study is raising the question of whether that pollution is contributing to suicides in rural.

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Webb discovers methane, carbon dioxide in atmosphere of K2-18 b

Science Daily: Pharmacology News

A new investigation with NASA's James Webb Space Telescope into K2-18 b, an exoplanet 8.6 times as massive as Earth, has revealed the presence of carbon-bearing molecules including methane and carbon dioxide. Webb's discovery adds to recent studies suggesting that K2-18 b could be a Hycean exoplanet, one which has the potential to possess a hydrogen-rich atmosphere and a water ocean-covered surface.

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Old Age & Heat Can Be Deadly Combo: Tips to Stay Safe

Drugs.com

MONDAY, Sept. 11, 2023 -- Hot weather can pose serious health risks for older adults. Existing medical conditions, problems moving around and medications raise the risk of heatstroke, according to an expert at Rush University Medical Center in.

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Floating sea farms: A solution to feed the world and ensure fresh water by 2050

Science Daily: Pharmacology News

The sun and the sea -- both abundant and free -- are being harnessed in a unique project to create vertical sea farms floating on the ocean that can produce fresh water for drinking and agriculture.

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Novartis stops work on gene therapy acquired in Gyroscope deal

BioPharma Drive: Drug Pricing

The decision follows a review by a trial monitoring committee, which concluded data for the geographic atrophy treatment didn't support further development.

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The universe caught suppressing cosmic structure growth

Science Daily: Pharmacology News

As the universe evolves, scientists expect large cosmic structures to grow at a certain rate: dense regions such as galaxy clusters would grow denser, while the void of space would grow emptier.

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510(k) Modernization 2023

FDA Law Blog: Biosimilars

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.

FDA 64
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Lions on the brink -- New analysis reveals the differing threats to African lion populations

Science Daily: Pharmacology News

New results reveal that many of Africa's remaining lions live within small, fragmented populations at risk of disappearing. The researchers developed a new framework which integrates ecological and socio-political risk factors to better understand the fragility of these populations.

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In Good News for U.S., Flu Vaccine Working Well in South America

Drugs.com

MONDAY, Sept. 11, 2023 – In a finding that should ease the minds of Americans ahead of another flu season, this year's vaccines have already cut the risk of hospitalization in half during the South American winter, health officials report. Even.

Vaccine 64
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Ex-Sanofi executive Sibold joins Madrigal as new CEO

BioPharma Drive: Drug Pricing

Bill Sibold has led Sanofi's specialty care business unit for the past six years. He replaces Paul Friedman as head of the NASH drug developer.

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Cancer Care Tougher to Access in U.S. If English Second Language

Drugs.com

MONDAY, Sept. 11, 2023 -- Much has been made of how a lack of English proficiency can interfere with a patient’s ability to interact with their doctor and get the best health care possible. But language barriers can prevent cancer patients from.

Doctors 64
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New patent for Intra-cellular drug CAPLYTA

Drug Patent Watch

Annual Drug Patent Expirations for CAPLYTA Caplyta is a drug marketed by Intra-cellular and is included in one NDA. It is available from two suppliers. There are fifteen patents protecting… The post New patent for Intra-cellular drug CAPLYTA appeared first on DrugPatentWatch - Make Better Decisions.

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Perficient Colleague Quoted in Forrester Report: Five Levers Of Developer Experience For Developers

Perficient: Drug Development

Improving the developer experience has become a top priority for leading technology companies as demand for skilled software developers and technology professionals has reached an all-time high. At the grassroots level, developers are taking increased ownership of the developer experience to transform their work environment and drive positive change within their own teams.

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New patent for Abbvie drug UBRELVY

Drug Patent Watch

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

Drugs 59
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City Living Means More Coughs, Colds for Kids

Drugs.com

MONDAY, Sept. 11, 2023 -- Two new studies looked to explain an increased risk of respiratory infections like coughs and colds in babies and young children, finding city living to be among the culprits. Young children who grow up in towns and cities.

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Drug Patent Expirations for the Week of September 10, 2023

Drug Patent Watch

TYZEKA (telbivudine) Novartis Patent: 7,589,079 Expiration: Sep 11, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit… The post Drug Patent Expirations for the Week of September 10, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Archaeologists reveal largest palaeolithic cave art site in Eastern Iberia

Science Daily: Pharmacology News

Archaeologists have discovered a major Palaeolithic cave art site, arguably the most important found on the Eastern Iberian Coast in Europe.

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New patent expiration for Teva Branded drug PROAIR HFA

Drug Patent Watch

Annual Drug Patent Expirations for PROAIR+HFA Proair Hfa is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from five suppliers. There are… The post New patent expiration for Teva Branded drug PROAIR HFA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59