Mon.Apr 21, 2025

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Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Drug Discovery

By John W.M. Claud & Michelle L. Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a

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AEM Universal Editor: A Simpler, Smarter Way to Create Content

Perficient: Drug Development

AEM Universal Editor: A Simpler, Smarter Way to Create Content Adobe Experience Manager (AEM) has come a long way in empowering content authors. We started with static templates where even small changes required a developer and evolved to editable templates and Layout Mode, which finally gave authors visual control over their pages. Now, Adobe is flipping the script again with the Universal Editor.

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Study shows addressing working memory can help students with math difficulty improve word problem-solving skills

Science Daily: Pharmacology News

Working memory is like a mental chalkboard we use to store temporary information while executing other tasks. Scientists worked with more than 200 elementary students to test their working memory, assess its role in word-problem solving and if interventions could boost it and thereby improve their word problem solving skills. Results showed that improving working memory helped both students with and without math difficulties and can help educators more effectively by helping teach the science of

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Roeslein and Associates goes live with Oracle Project Driven Supply Chain

Perficient: Drug Development

Roeslein & Associates Business Challenge + Opportunity Replaced disparate and outdated legacy systems with Oracle Fusion Cloud Manufacturing at a well-established manufacturing company. We implemented a scalable Fusion solution, including Project Driven Supply Chain (PDSC), and full Financial and Supply Chain Management Suites to enable Roeslein to execute and extend their business processes globally.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Licensing Agreements in the Pharmaceutical Sector

Drug Patent Watch

"The Secret to Unlocking the Pharmaceutical Industry's Hidden Goldmine As a seasoned pharma professional, I've seen it time and time again: a promising new treatment, stifled by patent restrictions and licensing agreements that seem to favor the big players. But what if I told you that there's a way to level the playing field? A way to tap into the lucrative world of pharmaceutical licensing agreements, and come out on top?

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Elevating Outcomes with AI: Highlights from Agentforce Denver 2025

Perficient: Drug Development

R ecap of Agentforce World Tour Denver: A Hub of Innovation and Collaboration AI is redefining business, and the Agentforce World Tour Denver showcased the latest innovations right at our fingertips. Straight from Dreamforce, this one-day event delivered hands-on experiences, expert insights, and real-world applications to boost productivity, enhance customer engagement, and streamline operations.

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Coveo Recognizes Perficient Colleagues as MVPs in 2025

Perficient: Drug Development

Were excited to share that Coveo has honored seven of our Perficient colleagues with the prestigious title of Coveo Most Valuable Professional. To be considered for the recognition of Coveo MVP, applicants must have demonstrated exceptional skill in utilizing Coveo solutions, significantly contributing to the success of our mutual customers. In addition to platform mastery and deployment expertise, MVPs are evaluated based on content creation, thought leadership, product input, and creative posi

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High-fat, high-sugar diets impact cognitive function

Science Daily: Pharmacology News

New research links fatty, sugary diets to impaired brain function. The findings build on a growing body of evidence showing the negative impact of high-fat, high-sugar (HFHS) diets on cognitive ability, adding to their well-known physical effects.

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Supreme Court Case Targets Free Preventive Care Provided By The Affordable Care Act

Drugs.com

MONDAY, April 21, 2025 -- Colonoscopy for younger adults. Chest CT scans for lung cancer. Statin meds to lower cholesterol. Screening for drug addiction.More than 150 million Americans might lose no-cost access to these and other preventive care.

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High-tech sticker can identify real human emotions

Science Daily: Pharmacology News

Saying one thing while feeling another is part of being human, but bottling up emotions can have serious psychological consequences like anxiety or panic attacks. To help health care providers tell the difference, a team has created a stretchable, rechargeable sticker that can detect real emotions -- by measuring things like skin temperature and heart rate -- even when users put on a brave face.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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CDC Cancels Measles Help for Texas Schools Amid Staff Layoffs

Drugs.com

MONDAY, April 21, 2025 The U.S. Centers for Disease Control and Prevention (CDC) has canceled its plans to help Texas schools stop the rapid spread of measles. The decision came after some CDC staff involved in this years outbreak response were t.

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The eukaryotic cell emerged as an evolutionary algorithmic phase transition

Science Daily: Pharmacology News

An international collaboration has published groundbreaking research, shedding light on the most significant increase in complexity in the history of life's evolution on Earth: the origin of the eukaryotic cell.

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Biological Link Identified Between Heavy Weed Use And Psychosis

Drugs.com

MONDAY, April 21, 2025 -- Theres a biological reason why heavy weed users are at increased risk of psychosis, a new study says.People with cannabis use disorder have higher levels of the hormone dopamine in the same region of the brain tied to p.

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More Americans are using psilocybin -- especially those with mental health conditions, study shows

Science Daily: Pharmacology News

Use of psilocybin, the hallucinogenic chemical found in what is known as 'magic mushrooms,' has increased significantly nationwide since 2019, according to a new study.

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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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Cutting-Edge Cancer Treatment, CAR T-Cell Therapy, Isn't Known By Most Americans

Drugs.com

MONDAY, April 21, 2025 -- Chris Vogelsang has had a long and terrible fight with cancer. Fourteen years ago, the 70-year-old man was first diagnosed with an aggressive form of lymphoma. His cancer has since returned twice, fighting against several.

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Did it rain or snow on ancient Mars? New study suggests it did

Science Daily: Pharmacology News

Geologists weigh in on a long-running debate about Mars: Billions of years ago, was the Red Planet warm and wet or cold and dry?

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Early Signs Of Autism Might Appear In Infants

Drugs.com

MONDAY, April 21, 2025 -- Fussiness, sleeplessness and unresponsiveness could be some of the earliest signs of autism in a baby, a new study says.Using these signs, parents might be able to help detect potential autism within a childs first year o.

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New research lays groundwork for early detection of Alzheimer's disease

Science Daily: Pharmacology News

A new study suggests that risk factors and biomarkers related to Alzheimer's disease are associated with cognition much earlier in life than previously recognized. The study highlights significant associations between cognition and Alzheimer's disease risk factors as young as ages 24 to 44 and underscores the importance of early prevention. This is the first study to systematically examine Alzheimer's disease risk factors, including biomarkers related to cognitive impairment in a large group of

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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 Shuts Down Key Labs for Hepatitis and STI Testing After Layoffs

Drugs.com

MONDAY, April 21, 2025 Key labs at the U.S. Centers for Disease Control and Prevention (CDC) have shut down amid recent layoffs, raising concerns about tracking and controlling serious infections like viral hepatitis and antibiotic-resistant g.

Disease 193
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How activity in Earth's mantle led the ancient ancestors of elephants, giraffes, and humans into Asia and Africa

Science Daily: Pharmacology News

What roils beneath the Earth's surface may feel a world away, but the activity can help forge land masses that dictate ocean circulation, climate patterns, and even animal activity and evolution. In fact, scientists believe that a plume of hot rocks that burst from the Earth's mantle millions of years ago could be an important part in the story of human evolution.

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Cutting-Edge Cancer Treatment Isn't Known By Most Americans

Drugs.com

MONDAY, April 21, 2025 -- Chris Vogelsang has had a long and terrible fight with cancer.Fourteen years ago, the 70-year-old man was first diagnosed with an aggressive form of lymphoma.His cancer has since returned twice, fighting against several.

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What if Mother Earth could sue for mistreatment?

Science Daily: Pharmacology News

The study highlights the transformative potential of the Rights of Nature, which views nature as a rights-bearing entity, not merely an object of regulation and subjugation by extractive industries. The Llurimagua case -- a dispute over a mining concession in Ecuador's cloud forest -- illustrates this approach, providing a unique opportunity to rethink Earth system governance.

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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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FDA and Novo Nordisk Alert Consumers to Counterfeit Ozempic

Drugs.com

MONDAY, April 21, 2025 -- The U.S. Food and Drug Administration and the pharmaceutical company Novo Nordisk are urging consumers to be on the lookout for counterfeit Ozempic (semaglutide) and to refrain from using the imitation drugs.Several.

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Wild chimps filmed sharing 'boozy' fruit

Science Daily: Pharmacology News

Wild chimpanzees have been pictured eating and sharing fruit containing alcohol.

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Chemo Drug, Hydroxyurea, Effective For Kids With Sickle Cell Disease

Drugs.com

MONDAY, April 21, 2025 -- An oral chemotherapy drug can safely and effectively manage sickle cell disease in children, a new study says. Children taking hydroxyurea had fewer ER visits and spent fewer days in the hospital compared to kids not.

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Enhertu combo tops standard drugs in first-line HER2 breast cancer

BioPharma Drive: Drug Pricing

The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for HER2-positive breast tumors for more than a decade.

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Lung Cancer Remains At Bay Long After Immune Therapy Is Dropped

Drugs.com

MONDAY, April 21, 2025 Immunotherapy might help keep lung cancer at bay for months or even years after the treatment has been abandoned due to side effects, a new study says.Immune checkpoint inhibitors essentially take the brakes off the immune s.

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The Key to Understanding Pricing and Reimbursement in the Nordics

thought leadership

It is easy to think that when you finally receive market approval for your drug, you have reached the finish line. However, what many do not realize is that there is still a final hurdle that can be both challenging and sometimes complicated to accomplish getting reimbursement granted and thereby gaining access to the market with your drug.

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Chemo Drug Effective For Kids With Sickle Cell Disease

Drugs.com

MONDAY, April 21, 2025 -- An oral chemotherapy drug can safely and effectively manage sickle cell disease in children, a new study says.Children taking hydroxyurea had fewer ER visits and spent fewer days in the hospital compared to kids not taking.

Disease 150
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How changes in lemur brains made some mean girls nice

Science Daily: Pharmacology News

If there was a contest for biggest female bullies of the animal world, lemurs would be near the top of the list. It's the ladies who get their way and keep males in line. In one branch of the lemur family tree, however, some species have evolved to have more harmonious relationships. New findings suggest that this amiable shift was driven by changes in the 'love hormone' oxytocin inside their brains.

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FDA May Shift Routine Food Inspections to States

Drugs.com

MONDAY, April 21, 2025 The U.S. Food and Drug Administration (FDA) may soon hand off routine food safety inspections to state and local officials, multiple federal health officials told CBS News.These changes are not final and could require a.

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Revumenib

New Drug Approvals

Revumenib SNDX-5613 2169919-21-3 LZ0M43NNF2 SNDX5613 C 32 H 47 FN 6 O 4 S, 630.82 SNDX-50613 free base SNDX-5613 free base SNDX50613 free base SNDX5613 free base FDA APPROVED 11/15/2024, Revuforj , To treat relapsed or refractory acute leukemia N -ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro- N -propan-2-ylbenzamide N-Ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fl