ASPET

AUGUST 23, 2024

The Acute Respiratory Distress Syndrome (ARDS), often preceded by acute lung injury (ALI), is characterized by the accumulation of inflammatory fluid in the lung alveoli, leaky alveolar epithelium and endothelium, and overexpression of pro-inflammatory cytokines. This progression from ALI to ARDS is a major contributor to the high mortality observed in COVID-19 patients.

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Science Daily: Pharmacology News

AUGUST 23, 2024

A study found that nondeceptive placebos, or placebos given with people fully knowing they are placebos, effectively manage stress -- even when the placebos are administered remotely.

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ASPET

AUGUST 23, 2024

Previous studies demonstrated that sigma-receptor (R) antagonists alone fail to alter cocaine self-administration despite blocking various other effects of cocaine. However, R antagonists when combined with dopamine transporter (DAT) inhibitors substantially decrease cocaine self-administration. To better understand the effects of this combination, the present study examined the effects of R antagonist and DAT inhibitor combinations in male rats discriminating cocaine (10 mg/kg, i.p.) from salin

Laboratories 100

Laboratories 100

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Research has already proven that the blockbuster weight-loss drug Wegovy (semaglutide) can slash a person's odds for heart attacks and strokes, and now more data from the same trial suggests that's even true for very ill.

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Trials Research Drugs 119

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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

AUGUST 23, 2024

Inter-organ cross-talk contributes to the pathogenesis of various disorders, and drug development based on inter-organ cross-talk is attracting attention. The roles of nitric oxide (NO) derived from the NO synthases system (NOSs) in inter-organ cross-talk remain unclear. We have investigated this issue by using our mice deficient in all three NOSs (triple n/i/eNOSs -/- mice).

Disease 100

Disease Drug Development Drugs 100

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Millions of people rely on medicines delivered by an inhaler to help manage chronic obstructive pulmonary disorder (COPD). But a new European study finds many patients are using inhalers improperly, keeping them from.

Disease 111

Disease 111

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- “Red flag” laws are an effective means of preventing suicide, a new study finds.About one life was saved for every 17 times that an extreme risk protection order (ERPO) kept firearms out of the hands of a troubled ind.

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Science Daily: Pharmacology News

AUGUST 23, 2024

The 7.5- magnitude earthquake beneath Japan's Noto Peninsula on Jan. 1, 2024, occurred when a 'dual-initiation mechanism' applied enough energy from two different locations to break through a fault barrier -- an area that locks two sides of a fault in place and absorbs the energy of fault movement, slowing it down or stopping it altogether.

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Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- A new type of cancer drug might help treat brain diseases like Alzheimer’s, mouse studies suggest.The drugs block an enzyme called indoleamine-2,3-dioxygenase 1 (IDO1), researchers reported.IDO1 inhibitors are being d.

Drugs 110

Drugs Disease Research 110

BioPharma Drive: Drug Pricing

AUGUST 23, 2024

Armed with clinical-stage data, Zenas BioPharma and Bicara Therapeutics both fit the profile of biotechs that have successfully pulled off IPOs this year.

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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.

Clinical Trials

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Women who suffer frequent migraines don’t have any increased risk of developing Parkinson’s disease, finds a new study that refutes earlier research.“These results are reassuring for women who have migraine, which itself cau.

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Disease Research 98

BioPharma Drive: Drug Pricing

AUGUST 23, 2024

Agency advisers will discuss whether use of Keytruda and Opdivo should be limited in gastric cancer. Elsewhere, a buzzy genetic drug startup is exploring “strategic options.

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FDA Drugs 62

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Many young adults are experimenting with “bed rotting” and other sleep trends that have gone viral on TikTok and other social media platforms, a new poll shows.Sleep experts say these trends likely won’t do any immediate har.

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Science Daily: Pharmacology News

AUGUST 23, 2024

A new study provides insights on the geophysics behind asteroid formation and evolution.

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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

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- People with HIV can no longer be turned away if they try to enlist in the U.S. military, a federal judge has ruled.The decision, issued this week by U.S. District Judge Leonie Brinkma, said the Pentagon’s ban on H.

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Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH Over a year since its initial draft guidance document on the use of Pre-Determined Change Control Plans (PCCPs) for medical devices that leverage machine learning, allowing sponsors to pre-specific certain post-authorization modifications, the agency has issued a new draft guidance on the use of PCCPs for all medical devices. Fill out the form to read the full article.

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Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Spend your youth glued to your phone, computer and TV and you cut your odds of making it to 60, a new study warns.Data from a study tracking the health of more than 4,000 young adults for over 30 years found a higher odds.

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Agency IQ

AUGUST 23, 2024

By Laura DiAngelo, MPH COURTNEY LIAS has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of TIM STENZEL at the end of 2023. At a conference in DC this week, she confirmed that she is now the permanent Director of OHT7. She takes over the office at a critical time for the office, which is at the forefront of several major regulatory reform efforts.

Production 59

Production 59

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Participation in youth sports is becoming a “haves” versus “have-nots” situation, a new study shows.Income, education and social class are determining who can play in youth sports leagues, with the children of more privile.

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Agency IQ

AUGUST 23, 2024

By Scott Stephens, MPA ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures. The document, which focuses on the “substantially similar mixtures” bridging principle and weight-of-evidence considerations, is a good indicator of where European authorities are likely focusing their limited resources in the context of C

Regulations 59

Regulations 59

Drugs.com

AUGUST 23, 2024

FRIDAY, Aug. 23, 2024 -- Human papillomavirus (HPV) has largely been seen as a health problem of women, given that it causes nearly all cases of cervical cancer.But men also have reason to both fear HPV and get vaccinated against it, a new study.

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Vaccine 52

Agency IQ

AUGUST 23, 2024

By Rachel Coe, MSC Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. AgencyIQ summarizes the noteworthy changes in the updates to several documents designed to help sponsors and other entities involved with clinical trials to transition to the Clinical Trials Information System (CTIS) on January 30, 2025.

Clinical Trials 52

Clinical Trials Trials 52

Perficient: Drug Development

AUGUST 23, 2024

If you use Databricks , you probably know that Databricks Unity Catalog is the industry’s only unified and open governance solution for data and AI, built into the Databricks Data Intelligence Platform. With Unity Catalog, organizations can seamlessly govern both structured and unstructured data in any format, as well as machine learning models, notebooks, dashboards and files across any cloud or platform.

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Government Compliance International Regulations 52

Drug Channels

AUGUST 23, 2024

Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir reviews the cumbersome processes that affect providers’ preferences when prescribing a specialty drug to their patients. He believes that embedding the specialty drug initiation process into the provider’s workflow will benefit both patients and prescribers. Learn more by downloading CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

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Production Drugs 52

Perficient: Drug Development

AUGUST 23, 2024

Databricks Unity Catalog is a unified and open governance solution for data and AI, built into the Databricks Data Intelligence Platform. Unity Catalog offers a comprehensive solution for enhancing data governance, operational efficiency, and technological performance. By centralizing metadata management, access controls, and data lineage tracking, it simplifies compliance, reduces complexity, and improves query performance across diverse data environments.

Government 52

Government Compliance Production 52

Agency IQ

AUGUST 23, 2024

What’s on FDA’s new Diagnostics Chief’s mind? Transitions, the LDT rule and cybersecurity Courtney Lias has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of Tim Stenzel at the end of 2023. At a conference in DC this week, she confirmed that she is now the permanent Director of OHT7. She takes over the office at a critical time for the office, which is at the forefront of several major regulatory reform efforts.

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FDA Laboratories Regulations Clinical Trials 40

ASPET

AUGUST 23, 2024

Despite a significant decrease in the number of prescriptions for opioids, the opioid crisis continues, fueled in large part by the availability of the phenylpiperadine mu opioid receptor (MOR) agonist fentanyl. In contrast, the number of prescriptions for and the off-label use of gabapentinoids (gabapentin and pregabalin) has increased dramatically with gabapentinoids commonly detected in opioid overdose victims.

Regulations 100

Regulations Drugs 100

Agency IQ

AUGUST 23, 2024

CDRH unveils new guidance on Pre-Determined Change Control Plans for medical devices Over a year since its initial draft guidance document on the use of Pre-Determined Change Control Plans (PCCPs) for medical devices that leverage machine learning, allowing sponsors to pre-specific certain post-authorization modifications, the agency has issued a new draft guidance on the use of PCCPs for all medical devices.

Science 40

Science FDA Marketing Production 40

Perficient: Drug Development

AUGUST 23, 2024

Responsible, trusted, effective AI solutions start with strategy. Scalable solutions move beyond a basic implementation. Effective AI Solutions Start with a Comprehensive Strategy In the realm of generative artificial intelligence, the allure of “magical AI solutions” captures the attention of executives. However, as this infographic aptly illustrates, the visible success of AI is just the tip of the iceberg.

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Regulations Compliance Government Production 52

Agency IQ

AUGUST 23, 2024

ECHA issues guidelines for enforcing mixture classification based on bridging principles ECHA has issued a new guide for national enforcement authorities (NEAs), clarifying the tiered approach to mixtures classification under the CLP Regulation and strategies for reviewing duty holders’ classifications of hazardous mixtures. The document, which focuses on the “substantially similar mixtures” bridging principle and weight-of-evidence considerations, is a good indicator of where European authoriti

Packaging 40

Packaging Regulations Compliance Production 40

Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents. AgencyIQ summarizes the noteworthy changes in the updates to several documents designed to help sponsors and other entities involved with clinical trials to transition to the Clinical Trials Information System (CTIS) on January 30, 2025.

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Clinical Trials Trials Regulations Production 40