Sat.Jul 27, 2024 - Fri.Aug 02, 2024

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Link between global warming and rising sea levels

Science Daily: Pharmacology News

A new study suggests that Earth's natural forces could substantially reduce Antarctica's impact on rising sea levels, but only if carbon emissions are swiftly reduced in the coming decades. By the same token, if emissions continue on the current trajectory, Antarctic ice loss could lead to more future sea level rise than previously thought.

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Talk of the Towne episode 11: American Kidney Fund

Antidote

In the latest installment of Talk of the Towne, we sat down with Melanie Paris, M.A., MPH, the Senior Director of Strategic Partnerships and Kidney Disease Education at the American Kidney Fund (AKF). In the discussion, we got her insights into the types of kidney disease, treatment disparities, and the importance of clinical research in the field. She also shared many valuable resources for individuals and their loved ones living with kidney disease, which are linked here.

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Primaquine-5,6-orthoquinone is directly hemolytic to older G6PD deficient RBCs in a humanized mouse model. [Toxicology]

ASPET

Primaquine and tafenoquine are the only approved drugs that can achieve a radical cure for Plasmodium vivax malaria but are contraindicated in patients who are deficient in glucose 6-phosphate dehydrogenase (G6PDd) due to risk of severe hemolysis from reactive oxygen species (ROS) generated by redox cycling of drug metabolites. 5-hydroxyprimaquine and its quinone-imine cause robust redox cycling in red blood cells (RBCs), but are so labile as to not be detected in blood or urine.

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Pfizer quits Duchenne gene therapy, lays off staff following study setback

BioPharma Drive: Drug Pricing

The company is letting go of 150 staffers alongside a decision to officially terminate the high-profile program, which was acquired in 2016.

Therapies 135
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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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Virus that causes COVID-19 is widespread in wildlife, scientists find

Science Daily: Pharmacology News

SARS-CoV-2, the virus responsible for COVID-19, is widespread among wildlife species, according to new research. The virus was detected in six common backyard species, and antibodies indicating prior exposure to the virus were found in five species, with rates of exposure ranging from 40 to 60 percent depending on the species.

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FDA Approves Another Blood Test for Colon Cancer Screening

Drugs.com

MONDAY, July 29, 2024 -- The U.S. Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's.

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Lilly obesity drug shows heart benefit in late-stage trial

BioPharma Drive: Drug Pricing

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

Trials 121
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Generation X and millennials in US have higher risk of developing 17 cancers compared to older generations

Science Daily: Pharmacology News

A new large study suggests incidence rates continued to rise in successively younger generations in 17 of the 34 cancer types, including breast, pancreatic, and gastric cancers. Mortality trends also increased in conjunction with the incidence of liver (female only), uterine corpus, gallbladder, testicular, and colorectal cancers.

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Legit Ozempic Sales Soar While Counterfeits Put Patients in Danger

Drugs.com

FRIDAY, Aug. 2, 2024 -- Two new studies show how eager Americans are to obtain either safe, legitimate versions of Ozempic or counterfeit and potentially dangerous forms of the diabetes/weight-loss drug.One study found U.S. prescriptions and.

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Perficient Included In Forrester’s Modern Application Development Services Landscape, Q3 2024

Perficient: Drug Development

Imagine a world where your business can effortlessly keep pace with technological advancements and continuously changing customer expectations. The ability to swiftly develop new technology products and applications is crucial to staying competitive. However, relying solely on in-house development capabilities is not always feasible for many organizations.

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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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First-of-its-kind cell therapy approved by FDA for rare soft tissue cancer

BioPharma Drive: Drug Pricing

Adaptimmune’s Tecelra is the first TCR cell therapy to reach market and, at $727,000, is also the priciest cellular medicine for cancer in the U.S.

Therapies 121
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Retreat of tropical glaciers foreshadows changing climate's effect on the global ice

Science Daily: Pharmacology News

As they are in many places around the globe, glaciers perched high in the Andes Mountains are shrinking. Now, researchers have uncovered evidence that the high-altitude tropical ice fields are likely smaller than they've been at any time since the last ice age ended 11,700 years ago.

Research 139
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FDA Warns of Accidental Overdoses from Compounded Versions of Ozempic

Drugs.com

TUESDAY, July 30, 2024 -- People taking compounded versions of Ozempic have been overdosing on the drug, the U.S. Food and Drug Administration warns.These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA.

FDA 115
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Real-World Evidence in Clinical Drug Development

Quanticate

Real-world evidence (RWE) is changing clinical drug development, bridging the gap between controlled clinical trial environments and the complexities of everyday patient experiences. By using Real-World Data (RWD) from various sources like electronic health records (EHRs), insurance claims, and digital health tools, researchers can gather valuable insights into how drugs work in a wide range of populations.

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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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Moderna shares fall amid lower sales outlook for RSV, COVID shots

BioPharma Drive: Drug Pricing

The biotech cited competitive pressure and “very low” expected sales in Europe for its latest guidance cut, which sent shares down by nearly 20%.

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Key to rapid planet formation

Science Daily: Pharmacology News

Researchers have developed a new model to explain the formation of giant planets such as Jupiter, which furnishes deeper insights into the processes of planet formation and could expand our understanding of planetary systems.

Research 139
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September is Peak Asthma Month: Is Your Child Ready?

Drugs.com

SUNDAY, July 28, 2024 -- Peak asthma month is upon parents as summer draws to a close, experts warn.“September is known as Asthma Peak Month because kids have returned to school, and viruses are being passed around,” said allergist Dr. Gailen Mar.

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Superhero Evan

KIF1A

“He really keeps us on our toes but he always has a smile on his face no matter the challenges he’s faced with.” A message from Evan’s family: Evan was diagnosed with KIF1A in May this year after a lot of tests, he’s been so brave and been put through it. It was scary at first as life would look alot different to how we thought it would but we are lucky as Evan is so happy, cheeky and energetic.

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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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Biotech startup Airna raises $60M for RNA editing medicines

BioPharma Drive: Drug Pricing

Launched last September, the company is working on a treatment for alpha-1 antitrypsin deficiency, which it said could enter the clinic in 2025.

RNA 116
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Half a billion-year-old spiny slug reveals the origins of mollusks

Science Daily: Pharmacology News

Exceptional fossils with preserved soft parts reveal that the earliest mollusks were flat, armored slugs without shells. The new species, Shishania aculeata, was covered with hollow, organic, cone-shaped spines. The fossils preserve exceptionally rare detailed features which reveal that these spines were produced using a sophisticated secretion system that is shared with annelids (earthworms and relatives).

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Mpox Has Surged in Africa Amid Shortages of Vaccines and Treatments

Drugs.com

FRIDAY, Aug. 2, 2024 -- Mpox cases have soared by 160% in Africa this year, as a lack of both vaccines and treatments hamper efforts to slow the spread of the virus.In a report released by the Africa Centers for Disease Control and Prevention on.

Vaccine 111
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A Guide to CDISC SDTM Standards and Domains

Quanticate

The Clinical Data Interchange Standards Consortium (CDISC) creates standards that are now mandatory for a regulatory submission to the FDA and PMDA. Study Data Tabulation Model (SDTM) is one of the standards which provides a standard for streamlined data in collection, management, analysis and reporting. If your data is not using SDTM standards then a you will have to perform SDTM mapping to the latest version of SDTM standards as you prepare for your regulatory submission.

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UniQure restructuring to claim 300 jobs

BioPharma Drive: Drug Pricing

The job cuts affects 65% of UniQure’s workforce and include the gene therapy developer’s recent sale of a manufacturing plant to Genezen.

Therapies 112
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Breaking MAD: Generative AI could break the internet, researchers find

Science Daily: Pharmacology News

Researchers have found that training successive generations of generative artificial intelligence models on synthetic data gives rise to self-consuming feedback loops.

Research 137
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Many Women Don't Know This Warning Sign of Endometrial Cancer

Drugs.com

FRIDAY, Aug. 2, 2024 -- Too many women don’t know a key warning sign of endometrial cancer, the most common cancer of the female reproductive organs, a new study shows.More than one-third (37%) of women surveyed did not know that postmenopausal b.

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Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research

PPD

Artificial Intelligence (AI) imitates human cognitive functions using computer science, algorithms, machine learning and data sciences. Simply put, AI refers to systems having the capability to perceive their surroundings, make logical deductions, interact with humans and acquire knowledge. These systems can be utilized for tasks resembling human abilities, such as recognizing images, understanding spoken words, planning and organizing.

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Bug Fixing: Lazy loaded property value is not supported by the current property instance

Perficient: Drug Development

While upgrading from CMS v11 to v12, we ran into an error that read “Lazy loaded property value is not supported by the current property instance” Unfortunately, the stack trace didn’t really say what the problem was. Here is that stack trace: System.InvalidOperationException: Lazy loaded property value is not supported by the current property instance at EPiServer.DataAccess.Internal.LazyPropertyValueLoader.SetValue(PropertyData property, PropertyDataRecord dataRecord, Func`3

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What no one has seen before -- simulation of gravitational waves from failing warp drive

Science Daily: Pharmacology News

Physicists have been exploring the theoretical possibility of spaceships driven by compressing the four-dimensional spacetime for decades. Although this so-called 'warp drive' originates from the realm of science fiction, it is based on concrete descriptions in general relativity. A new study takes things a step further -- simulating the gravitational waves such a drive might emit if it broke down.

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Daily Aspirin Cuts Odds for Colon Cancer: Who Benefits Most?

Drugs.com

THURSDAY, Aug. 1, 2024 -- It's long been known that a daily dose of low-dose aspirin helps keep colon cancer at bay.But new research suggests that those who benefit most are folks whose lifestyles up their odds for the disease in the first.

Disease 111
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15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

thought leadership

Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific situation, you probably panicked a little. It's human nature to panic when the law enforcement (or in this case the US FDA) tells you that you've done something wrong.

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GSK cuts vaccine forecasts, while predicting faster overall growth

BioPharma Drive: Drug Pricing

Several factors are slowing U.S. sales of Shingrix, the shingles vaccine that's become one of the British pharma's top sellers.

Vaccine 112
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Cannabinoid CBG reduces anxiety and stress in first human clinical trial

Science Daily: Pharmacology News

A lesser-known cannabinoid that is gaining in popularity Cannabigerol (CBG) effectively reduced anxiety in a clinical trial without the intoxication typically associated with whole plant cannabis. It may even have some memory enhancing effects, according to a new study. For the study, researchers conducted the first human clinical trial investigating the acute effects of CBG on anxiety, stress and mood.

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FDA Warns of Danger From At-Home Chemical Peels

Drugs.com

THURSDAY, Aug. 1, 2024 -- Don't use a chemical peel to help rejuvenate your skin unless it's done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised. "FDA is warning consumers not to purchase or use.

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