Tue.Jul 02, 2024

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CHMP okays first therapy targeting FGFR3 alterations in bladder cancer

Drug Discovery World

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Janssen-Cilag’s Balversa (erdafitinib). It is recommended as a monotherapy to treat adult patients with unresectable or metastatic urothelial carcinoma, harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.

Therapies 147
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Cartesian data add to progress, questions for CAR-T in autoimmune disease

BioPharma Drive: Drug Pricing

The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.

Disease 122
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Trial to test monoclonal antibody for virus of growing concern

Drug Discovery World

The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM). AFM has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade.

Virus 147
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Lilly drug for Alzheimer’s approved by FDA

BioPharma Drive: Drug Pricing

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

FDA 129
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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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Changing the gut microbiome improves outcomes in kidney cancer

Drug Discovery World

In a Phase I trial, patients with metastatic kidney cancer who took a live biotherapeutic product alongside immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. City of Hope, US, researchers are now in discussions with the global SWOG Cancer Research Network to design a Phase II/III trial to assess the novel use of CBM588 and microbiome modulation in people with advanced cancer.

Trials 147
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FDA Approves New Drug to Treat Alzheimer's, Kisunla

Drugs.com

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.

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Neutrons on classically inexplicable paths

Science Daily: Pharmacology News

Is nature really as strange as quantum theory says -- or are there simpler explanations? New neutron measurements prove: It doesn't work without the strange properties of quantum theory.

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U.S. Government to Pay Moderna $176 Million to Develop mRNA Flu Vaccine

Drugs.com

TUESDAY, July 2, 2024 -- U.S. health officials announced Tuesday that the federal government will pay Moderna $176 million to speed development of a pandemic flu vaccine based on mRNA technology.Such a vaccine could be used to treat bird flu in.

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How our brains develop facial recognition skills: New face-detecting brain circuit

Science Daily: Pharmacology News

Scientists have uncovered a brain circuit in primates that rapidly detects faces. The findings help not only explain how primates sense and recognize faces, but could also have implications for understanding conditions such as autism, where face detection and recognition are often impaired from early childhood.

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Most Americans Don't Know That Family Doctors Can Prescribe Anti-Opioid Meds

Drugs.com

TUESDAY, July 2, 2024 -- Most people addicted to opioids and their loved ones are unaware that their primary care doctor can prescribe a medication to treat the disorder, a new nationwide survey reveals."We've made great strides in making it easier.

Doctors 109
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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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Proteins and fats can drive insulin production for some, paving way for tailored nutrition

Science Daily: Pharmacology News

When it comes to managing blood sugar levels, most people think about counting carbs. But new research shows that, for some, it may be just as important to consider the proteins and fats in their diet. The study is the first large-scale comparison of how different people produce insulin in response to each of the three macronutrients: carbohydrates (glucose), proteins (amino acids) and fats (fatty acids).

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Use of 'Benzo' Sedatives Like Valium, Xanax Won't Raise Dementia Risk: Study

Drugs.com

TUESDAY, July 2, 2024 -- Benzodiazepines do not appear to increase dementia risk, but could have subtle long-term effects on brain structure, a new study reports.Researchers found no link between use of the sedative drug and a higher risk of.

Drugs 107
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How to Configure ServiceNow Knowledge Articles for Microsoft Graph Connector

Perficient: Drug Development

If you use ServiceNow as your knowledge management platform, you might want to make your knowledge articles searchable and accessible from Microsoft Search. Microsoft Search is a unified search experience that helps you find what you need across your organization, including files, sites, people, and more. By connecting your ServiceNow knowledge articles to Microsoft Search, you can enable your users to find and request them directly from the Microsoft 365 apps.

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An ant that selectively amputates the infected limbs of wounded sisters

Science Daily: Pharmacology News

Saving lives through surgery is no longer exclusive to humans. Scientists now detail how Florida carpenter ants, a common, brown species native to its namesake, selectively treat the wounded limbs of fellow nestmates -- either by wound cleaning or amputation. When experimentally testing the effectiveness of these 'treatments,' not only did they aid in recovery, but the research team found the ants' choice of care catered to the type of injury presented to them.

Treatment 104
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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 Handing a Child a Screen During a Tantrum Could Backfire Long-Term

Drugs.com

TUESDAY, July 2, 2024 -- When your preschooler pitches a fit, handing them a smartphone or tablet is probably the fastest -- and the worst -- way to stop it, a new study suggests."If parents regularly offer a digital device to their child to calm.

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Moderna gets US funding for bird flu vaccine development

BioPharma Drive: Drug Pricing

BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.

Vaccine 112
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FDA Approves New Drug to Treat Alzheimer's

Drugs.com

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday.In clinical trials, donanemab (Kisunla) modestly slowed the pace of thinking declines among patients in the early.

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Crucial gaps in climate risk assessment methods

Science Daily: Pharmacology News

Researchers have uncovered significant flaws in current climate risk assessment techniques that could lead to a severe underestimation of climate-related financial losses for businesses and investors.

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Some Genes Might Send Girls Into Puberty Earlier

Drugs.com

TUESDAY, July 2, 2024 -- A girl’s genetics can indirectly influence the age when she has her first period, by accelerating her weight gain in childhood, a new study finds.A number of other genes also can directly affect the age of puberty, some w.

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Doctors could soon use facial temperature for early diagnosis of metabolic diseases

Science Daily: Pharmacology News

A colder nose and warmer cheeks may be a telltale sign of rising blood pressure. Researchers discovered that temperatures in different face regions are associated with various chronic illnesses, such as diabetes and high blood pressure. These temperature differences are not easily perceptible by one's own touch but can instead be identified using specific AI-derived spatial temperature patterns that require a thermal camera and a data-trained model.

Doctors 96
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The Power of Patience: Delaying Patents to Enhance Pharma Market Exclusivity

Drug Patent Watch

The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.

Marketing 105
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Spotted apex predator being pressured by spotted pack hunters -- and it's our fault

Science Daily: Pharmacology News

Leopards, who are already in decline, can't keep up with hyenas when people are around. As we humans move into the their territories more and more, we are helping to disturb and unbalance ecosystems. This has been shown in a new study where researchers used camera traps to observe both large carnivore species.

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Exercise May Prevent the Nerve Damage That Comes With Chemotherapy

Drugs.com

TUESDAY, July 2, 2024 -- Simple exercises performed during rounds of chemotherapy can help people avoid nerve damage normally associated with the cancer-killing drugs, a new study suggests.About twice as many cancer patients on chemo wound up with.

Drugs 88
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Melting of Alaskan glaciers accelerating faster than previously thought

Science Daily: Pharmacology News

Melting of glaciers in a major Alaskan icefield has accelerated and could reach an irreversible tipping point earlier than previously thought. The research found that glacier loss on Juneau Icefield, which straddles the boundary between Alaska and British Columbia, Canada, has increased dramatically since 2010. The team looked at records going back to 1770 and identified three distinct periods in how icefield volume changed.

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Build Your CRISPR Vocabulary

addgene Blog

CRISPR is a sleek acronym for a real mouthful of a phrase: Clustered Regularly Interspaced Short Palindromic Repeats. That contrast of simplicity and complexity is reflected in the biology, too. CRISPR is an elegant bacterial immune system and an efficient gene editing tool… but boy does it have a lot of parts! If you’re still a bit confused by CRISPR acronyms, this post is for you.

RNA 84
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Implantable microphone could lead to fully internal cochlear implants

Science Daily: Pharmacology News

Researchers developed a prototype of an implantable microphone for a cochlear implant. Their device, which senses the movement of the ear drum in the inner ear, performed as well as commercial hearing aids and could someday enable a fully internalized cochlear implant.

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Tattoo Inks Can Be Contaminated With Bacteria: Study

Drugs.com

TUESDAY, July 2, 2024 — Getting inked could make you sick.In a first-of-its-kind study, researchers detected bacteria in commercial tattoo and permanent makeup inks, demonstrating that they could cause human infections."Our findings reveal that u.

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True scale of carbon impact from long-distance travel revealed

Science Daily: Pharmacology News

The reality of the climate impact of long-distance passenger travel has been revealed in new research.

Research 109
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Ultrasound May Be Unreliable in Spotting Endometrial Cancer in Black Women

Drugs.com

TUESDAY, July 2, 2024 -- Ultrasound cannot reliably rule out endometrial cancer in Black women given how readings are now assessed, a new study argues.Transvaginal ultrasound is commonly used to screen for cancer by measuring the thickness of the.

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Research shows how RNA 'junk' controls our genes

Science Daily: Pharmacology News

Researchers have made a significant advance in understanding how genes are controlled in living organisms. The new study focuses on critical snippets of RNA in the tiny, transparent roundworm Caenorhabditis elegans (C. elegans). The study provides a detailed map of the 3'UTR regions of RNA in C. elegans. 3'UTRs (untranslated regions) are segments of RNA involved in gene regulation.

RNA 75
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Biden Administration Proposes Rule to Tackle Extreme Heat in the Workplace

Drugs.com

TUESDAY, July 2, 2024 -- As millions of Americans grapple with blistering heat this summer, the Biden Administration on Tuesday proposed a new rule to address excessive heat in the workplace.If the first major federal safety standard of its kind.

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Optoelectronics gain spin control from chiral perovskites and III-V semiconductors

Science Daily: Pharmacology News

A research effort has made advances that could enable a broader range of currently unimagined optoelectronic devices.

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Supreme Court to Hear Case Challenging FDA's Ban of Flavored Vapes

Drugs.com

TUESDAY, July 2, 2024 -- In a case that will test the U.S. Food and Drug Administration's authority to approve or reject new vaping products, the U.S. Supreme Court said Tuesday it will weigh whether the agency was legally allowed to ban flavored.

FDA 73
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Clever clothes! Seams in clothing capture body movement

Science Daily: Pharmacology News

Everyday clothing may soon be able to capture and record body movements according to new research.