Fri.Apr 12, 2024

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This week in drug discovery (8-12 April) 

Drug Discovery World

News round-up for 8-12 April by DDW Digital Content Editor Diana Spencer. The cancer research news has been coming thick and fast from the American Association of Cancer Research (AACR) Annual Meeting in San Diego this week, so our Friday round-up focuses on drug discovery in oncology. The top stories: Genetically engineered dendritic cells enhance lung cancer therapy A study by researchers at the UCLA Health Jonsson Comprehensive Cancer Center in the US suggests that injecting engineered dendri

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Chlamydia Vaccine Shows Promise in Early Trial

Drugs.com

FRIDAY, April 12, 2024 -- A chlamydia vaccine has triggered immune responses in an early trial, raising hopes that one day it might help curb the spread of the sexually transmitted infection (STI).There is currently no vaccine for chlamydia, which.

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First tumour agnostic HER2 directed ADC gets US approval

Drug Discovery World

Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumours. Enhertu has been granted accelerated approval to treat patients who have received prior systemic treatment and have no satisfactory alternative treatment options.

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Iconic savanna mammals face genetic problems due to fences and roads

Science Daily: Pharmacology News

Wildebeest migrations have become a rarer sight in Africa as humans continue to interrupt their historic migratory routes with roads, fences, cities, livestock and farmland. This has led to genetic decay in those herds that are no longer able to roam freely, according to new research.

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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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FDA green light for trial of allogeneic regulatory T cell therapy

Drug Discovery World

The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for Tr1X’s TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched haematopoietic stem cell transplantation (HSCT). The company plans to initiate a Phase I study of the investigational allogeneic off-the-shelf Tr1 Treg therapy for this indication in the second quarter of 2024.

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Stellar winds of three sun-like stars detected for the first time

Science Daily: Pharmacology News

An international research team has for the first time directly detected stellar winds from three Sun-like stars by recording the X-ray emission from their astrospheres, and placed constraints on the mass loss rate of the stars via their stellar winds.

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Brightest gamma-ray burst of all time came from the collapse of a massive star

Science Daily: Pharmacology News

In 2022, astronomers discovered the brightest gamma-ray burst (GRB) of all time. Now, astronomers confirm that a 'normal' supernova, the telltale sign of a stellar collapse, accompanied the GRB. The team also looked for signatures of heavy elements like gold and platinum in the supernova. They found no evidence of such elements, deepening the mystery of their origins.

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New Treatment with Imiquimod Could Be An Advance Against Cervical Precancers

Drugs.com

FRIDAY, April 12, 2024 -- Women who undergo regular Pap smears are no doubt familiar with the possibility of "precancerous" cells being detected. These cells -- called cervical intraepithelial neoplasias (CINs) -- can progress to full-blown.

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Biotech IPOs bounced back in first quarter, but backlog remains

BioPharma Drive: Drug Pricing

Proceeds from biotech IPOs during the first three months of 2024 matched levels seen in the first quarters of 2019 and 2020, BioPharma Dive data shows.

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Spike in Measles Cases Could Threaten Elimination Status in U.S.: CDC

Drugs.com

FRIDAY, April 12, 2024 -- More than 100 measles cases have already been reported in the United States this year, a significant increase over previous years that threatens the country's attempts to eliminate the illness, federal health officials.

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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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Roche, Adaptimmune part ways on cell therapy research

BioPharma Drive: Drug Pricing

The two companies have ended a collaboration that was struck in 2021 and focused on “off-the-shelf” cell therapies for cancer.

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Unleashing AI in Drug Discovery: Prospects and Challenges

DrugBank

The digital age, mirroring the rapid evolution of the industrial revolution, has ushered in a new era of advancing technology across various sectors, with life sciences and healthcare at its forefront. Over the past decade, the drug discovery landscape has been revolutionized by the adoption of artificial intelligence (AI) and machine learning (ML), witnessing early adopters leapfrog into pioneering technologies aimed at streamlining the drug development process and curtailing associated costs.

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Almost 1 in 4 People Disenrolled From Medicaid Are Now Uninsured

Drugs.com

FRIDAY, April 12, 2024 -- Nearly a quarter of Americans who lost their pandemic-era Medicaid coverage say they're now without any health insurance, a new survey finds. More than half (54%) of these currently uninsured adults cited cost as the.

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Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. Now, the deadline for feedback to that draft guidance has passed, and AgencyIQ has an analysis of the comments here. As defined in statute, the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.

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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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Big Rise in Young Adults Undergoing Permanent Sterilization After Dobbs Decision

Drugs.com

FRIDAY, April 12, 2024 -- An increasing number of young men and women have decided they never want parenthood in the wake of the Dobbs decision revoking the constitutional right to an abortion, a new study finds.The number of young adults opting to.

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The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

BY KIRSTEN MESSMER, PHD, RAC This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. MEP statements during a debate ahead of the vote highlighted alignment on provisions such as regulatory data protection and incentives for antimicrobial research.

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Automotive Dealerships Should Look More Like Genius Bars

Perficient: Drug Development

When we conducted our electric vehicle customer journey research last year, we confirmed a commonly held belief in the United States: most people aren’t happy with their dealership experiences, specifically as it relates to aggressive sales tactics. Automotive customers desire experiences and service centers that meet their needs, listen to their concerns, and provide a comfortable environment to explore vehicles at their own pace.

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French PFAS ban exempts cookware, clears National Assembly

Agency IQ

BY RAYAN BHARGAVA, MSC Last week, the French National Assembly adopted a bill aiming to restrict the presence of PFAS in certain consumer products. The bill, which would be the first of its kind among EU member states, has been the subject of intense lobbying, which ultimately resulted in the exemption of kitchen utensils and cookware. Fill out the form to read the full article.

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Parents, You Can Ease a Teen's Stress Around Standardized Tests

Drugs.com

FRIDAY, April 12, 2024 -- Standardized tests put a lot of pressure on teenagers who want to secure their future and make their parents and teachers proud.This stress can lead to symptoms like stomach aches, sleep problems, irritability and.

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Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

BY LAURA DIANGELO, MPH In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In this article, AgencyIQ explores the current regulatory state of decentralized trials and what’s likely coming next. Decentralized clinical trials (DCTs) employ technologies to remotely communicate with study participants and collect clinical data.

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Tips To Getting Your Rosacea Under Control

Drugs.com

FRIDAY, April 12, 2024 -- Rosacea is a common skin condition that causes redness on a person’s face.It commonly appears as a tendency to blush or flush more easily, but also can cause more serious symptoms like:Swollen skin.

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EPA releases final PFAS drinking water regulations – with five-year compliance timeline

Agency IQ

BY WALKER LIVINGSTON, ESQ The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. The finalized rule includes new individual limits for some PFAS and gives water systems five years to be able to comply with the drinking water contaminant levels. Per- and polyfluoroalkyl substances are a large group of synthetic organic chemicals used in many different industrial, commercial, and consumer applications since the 1940s.

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New Treatment Could Be Advance Against Cervical Precancers

Drugs.com

FRIDAY, April 12, 2024 -- Women who undergo regular Pap smears are no doubt familiar with the possibility of "precancerous" cells being detected. These cells -- called cervical intraepithelial neoplasias (CINs) -- can progress to full-blown.

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How Patient Engagement Can Reduce Brand Launch Risks

Drug Channels

Today’s guest post comes from Jessica Lens, Chief Patient Experience Officer at CareMetx. Jessica discusses the challenges of patient nonadherence. She then outlines how manufacturers can build adherence into their patient services program to increase patient engagement. To learn more about enhancing patient engagement and adherence, download CareMetx's new report: Driving Brand Success: Minimize Risk and Capture Missed Value from Patient Engagement and Adherence.

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Blood Loss Drives Higher Death Rate for Women During Bypass Surgeries

Drugs.com

FRIDAY, April 12, 2024 -- It's long been documented that women have a slimmer chance of surviving heart bypass surgery compared to men, and researchers believe that they now know why.Women tend to be more vulnerable to blood loss during surgery --.

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Everything You Need to Know About Virtual Clinical Trials

Quanticate

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before. Virtual clinical trials are not just a temporary solution to the challenges posed by global events like the COVID-19 pandemic.

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Young Women Often Delay Looking Into Breast Symptoms

Drugs.com

FRIDAY, April 12, 2025 -- Young women who find a lump or other potential signs of breast cancer often delay for weeks before finally seeing a doctor, a new study shows.On average, young women waited two weeks before seeing a doctor about troubling.

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The New EU HTA Landscape: Insights on Indirect Evidence

Cytel

How should health technology developers prepare for future market access activities in Europe? Numerous discussions have already taken place in various forms and on various platforms around the upcoming implementation of the EU Joint Clinical Assessments (JCA); it’s a hot topic and keeps many of us in our industry occupied. Despite the European Commission’s active efforts in developing draft regulation and related materials to support the transition to JCA, to date, some questions remain unanswe

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Seafood Can Pass on PFAS 'Forever Chemicals,' Study Finds

Drugs.com

FRIDAY, April 12, 2024 -- Cancer-linked 'forever chemicals' made news this week, with the Biden Administration vowing to cut levels in the nation's tap water.New research finds that the chemicals, known as PFAS, can also contaminate the seafood.

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Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. Now, the deadline for feedback to that draft guidance has passed, and AgencyIQ has an analysis of the comments here.

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'Virtual Biopsy' Tests Skin Lesions Without a Scalpel

Drugs.com

FRIDAY, April 12, 2024 -- Folks with a suspicious-looking mole or questionable skin lesion often have to endure a scalpel or shaver so their doctor can cut off a sample to send in for biopsy.But a new, noninvasive “virtual biopsy” might soon.

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Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In this article, AgencyIQ explores the current regulatory state of decentralized trials and what’s likely coming next.

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Pandemic's Effect in Isolating Older Americans May Not Be Over

Drugs.com

FRIDAY, April 12, 2024 -- COVID-19 lockdowns prompted countless American seniors to become socially isolated.Now, new research finds that many have still not fully rejoined society.More than half of older adults still spend more time at home and.

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Analysis Chemical Thank You EPA releases final PFAS drinking water regulations – with five-year compliance timeline

Agency IQ

EPA releases final PFAS drinking water regulations – with five-year compliance timeline The EPA has released its much-awaited National Primary Drinking Water Regulation for six different PFAS. The finalized rule includes new individual limits for some PFAS and gives water systems five years to be able to comply with the drinking water contaminant levels.