Thu.Mar 09, 2023

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Lilly reaches end of the road with long-studied Alzheimer’s drug

Bio Pharma Dive

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

Drugs 306
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Depressive Symptoms And Memory Loss in Older Adults Linked to Telomere Shortening

AuroBlog - Aurous Healthcare Clinical Trials blog

There’s a tiny, slow-burning ‘fuse’ attached to the ends of all our chromosomes, and as we naturally age, each of our cells loses more and more of that life-giving line.

Research 183
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AstraZeneca builds on study successes in early lung cancer

Bio Pharma Dive

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

Trials 300
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Innovation in immuno-oncology: Leading companies in tumour antibody serum compositions

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Tumour antibody s

Antibody 147
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Sandoz, betting on biosimilar sales, to build new production plant

Bio Pharma Dive

The Novartis division will invest at least $400 million in a new manufacturing facility in Slovenia amid expectations that demand for copycat biologics will surge in the coming years.

Sales 183
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Health ministry to rope in state governments to establish medical devices testing laboratories

AuroBlog - Aurous Healthcare Clinical Trials blog

The ministry of health and family welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory […]

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Innovation in immuno-oncology: Leading companies in in-vitro T-cell activation

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: In-vitro T-cell a

In-Vitro 130
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Pfizer CEO Albert Bourla maxed out campaign contributions to Dr. Oz ahead of midterm elections

STAT News

WASHINGTON — Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records. Oz is well-known for spreading medical misinformation , including touting astrology as a legitimate medical tool and the myth that apple juice contains unsafe levels of arsenic — a surprising political ally for Bourla, who runs one of the largest pharmaceutica

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Leading innovators in monoclonal antibody drugs for cancer for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Monoclonal antibody dr

Antibody 130
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STAT+: ‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments

STAT News

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. “Anne” is sitting in a small, wood-paneled consultation room, at the Mayo Clinic in Rochester, Minn., about to embark on yet another weight loss journey.

Doctors 133
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Leading innovators in platinum as active pharmaceutical ingredient for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Platinum as active pha

Antibody 130
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The first wiring map of an insect's brain hints at incredible complexity

NPR Health - Shots

Researchers have mapped the more than 500,000 connections in the intricate brain of a fruit fly larva. This map, they say, could help scientists figure out how learning changes the human brain, too.

Scientist 128
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Leading innovators in transgenic murine models for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Transgenic murine mode

In-Vivo 130
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These 6 tips can help you skip the daylight saving time hangover

NPR Health - Shots

The lingering jet-lagged feeling you get when daylight saving time begins and ends can disrupt your health as well as your mood. Try these 6 tips from sleep experts to make next week easier.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Leading innovators in tyrosine kinase inhibitors for the pharmaceutical industry

Pharmaceutical Technology

The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Tyrosine kinase inhibi

Protein 130
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Biden administration requests $20 billion cash infusion to bolster public health

STAT News

WASHINGTON — The Biden administration is calling for a big boost for public health funding across the federal health department, but left out specific funding for Covid-19 activities. In its budget request to Congress on Thursday, the White House asked for $20 billion over five years to support pandemic preparedness efforts at the Administration for Strategic Preparedness and Response, Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Adminis

Drugs 111
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FlyPharma Europe, Vienna – 2023 conference officially launched

Pharma Times

FlyPharma Europe chose Vienna for its latest conference due to the growing presence of Austrian biotechnology and pharmaceutical manufacturing

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Honduran president ends ban on emergency contraception, making it widely available

NPR Health - Shots

President Xiomara Castro, the country's first female leader, announced the policy shift in the final hours of International Women's Day.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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STAT+: Insulin for $20 a vial? Sanders pushes bill for price caps on the diabetes treatment

STAT News

Now that Eli Lilly is cutting prices on some of its insulin products, Sen. Bernie Sanders (I-Vt.) is seeking to build on that momentum. This week, he introduced a bill that would place a $20 cap on all insulin, a move designed to drastically lower costs for millions of Americans. The legislation — dubbed the Insulin for All Act — would prohibit all insulin manufacturers from charging more than $20 per vial.

Insulin 98
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A new class of drugs could prevent resistant COVID-19 variants, study finds

Medical Xpress

The constant evolution of new COVID-19 variants makes it critical for clinicians to have multiple therapies in their arsenal for treating drug-resistant infections. Researchers have now discovered that a new class of oral drugs that acts directly on human cells can inhibit a diverse range of pathogenic SARS-CoV-2 strains.

Drugs 98
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STAT+: Biden makes drug pricing a central part of his deficit reduction plans

STAT News

WASHINGTON — President Biden made lowering drug prices a key part of his budget with proposals to expand Medicare drug price negotiation, squeeze more rebates out of drug companies, and lower the cost of insulin for everyone with insurance. The request made Thursday also details a $7.2 billion ask for the Food and Drug Administration, which includes funding specifically set aside for improving the oversight of food manufacturing, regulating cosmetics, and making the medical device supply

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Emergency department visits for attempted suicides rose globally among youth during pandemic, shows meta-analysis

Medical Xpress

Even though pediatric emergency department visits decreased greatly overall during the COVID-19 pandemic, a newly published study led out of the University of Calgary shows there was also a sharp increase in emergency department visits for attempted suicide and suicide ideation among children and adolescents in that same period of social isolation.

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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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‘Truth is losing the battle’: FDA commissioner on grappling with a wave of health misinformation

STAT News

The Food and Drug Administration is considering whether it needs to revamp guidance on how FDA-regulated manufacturers should deal with online misinformation about their products as the agency continues to contend with a deadly tide of falsehoods spreading on social media, Commissioner Robert Califf told STAT. In an interview, FDA Commissioner Robert Califf said the agency is grappling with how best to handle an explosion of misinformation, including vaccine skepticism that has worsened the toll

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Researchers discover the role of intestinal fibrosis in inflammatory bowel disease

Medical Xpress

Intestinal fibrosis is a common feature of inflammatory bowel disease (IBD) and the primary cause of end-stage organ failure. Traditionally considered a bystander of inflammation, with negligible involvement in disease pathogenesis, new research published in Gastroenterology now shows that fibrosis has a direct bearing on disease progression in IBD.

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Watch: The troubled history of BMI, the body mass index

STAT News

The body mass index, or BMI, is the formula that’s used most often to diagnose overweight and obesity. But unlike other common diagnoses, there is a certain stigma applied to people with a high body mass index, or BMI, which can affect how they are perceived by peers, providers, and society at large. Despite the ubiquity of the BMI in medicine, many argue that it is a flawed tool, with a strange history.

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States with high COVID-19 death rates also saw high mortality from other causes

Medical Xpress

During the first year of the pandemic, states in the U.S. with high rates of death from COVID-19 saw significant increases in other causes of death, too, including cardiovascular disease, dementia, diabetes, and influenza. That's according to findings from the University of Pennsylvania, Boston University, and the Robert Wood Johnson Foundation published recently in the journal PLOS ONE.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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STAT+: Biden makes big demands for cancer research and new ARPA-H agency

STAT News

President Biden is banking on longtime bipartisan interest in eliminating cancer deaths to secure some of his most significant health spending increases for next year. In a long-awaited 2024 budget proposal released Thursday, the president asked for a combined $3.6 billion over the next few years to be channeled to the Cancer Moonshot, a mission to end cancer that he first launched as vice president in 2016, less than a year after his son Beau’s death from brain cancer.

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Naturally occurring peptide may tackle the 'root cause' of obesity-related conditions

Medical Xpress

Research published today in Clinical and Experimental Immunology shows that a peptide (small protein) called PEPITEM could provide a revolutionary approach to reducing the risk of type 2 diabetes and other obesity-related diseases such as hepatic steatosis (fatty liver).

Protein 98
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STAT+: Mice with two fathers and base-edited baby monkeys highlight potential — and limitations — of hereditable gene editing

STAT News

LONDON — Scientists at this year’s genome editing summit spent Tuesday showing the world just how far CRISPR -based medicines for treating human diseases have come in a decade. But Wednesday was an exhibition in how far the same technology has to go before it might be safely used to alter the genetic afflictions people may pass on to future generations.

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7 Benefits of integrating EDC with CTMS, eTMF and Safety

Cloudbyz

Integrating electronic data capture (EDC) with other clinical trial management systems like clinical trial management systems (CTMS), electronic trial master files (eTMF), and safety systems can offer numerous benefits to pharmaceutical companies, contract research organizations (CROs), and academic research institutions. Here are some of the quantifiable benefits of integrating EDC with CTMS, eTMF, and safety systems: Improved data quality and accuracy: Integrating EDC with CTMS, eTMF, and safe

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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.