Pharmaceutical Technology

FEBRUARY 20, 2023

The US Food and Drug Administration (FDA) has granted approval for Apellis Pharmaceuticals’ Syfovre (pegcetacoplan injection) to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). Syfovre has been approved for use in people with GA with or without subfoveal involvement and offers dosing flexibility with a regimen of every 25 to 60 days for patients and physicians.

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FDA Approval Trials Drugs 246

NPR Health - Shots

FEBRUARY 20, 2023

Florida's medical boards have voted to ban gender-affirming care for transgender youth. Families with trans children and medical providers who care for them are worried about the impact.

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Rethinking Clinical Trials

FEBRUARY 20, 2023

NIH Pragmatic Trials Collaboratory Fact Sheet A handout providing information about the NIH Collaboratory and pragmatic clinical trials The post NIH Pragmatic Trials Collaboratory Fact Sheet appeared first on Rethinking Clinical Trials.

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Trials Clinical Trials Clinical Trials 100

NPR Health - Shots

FEBRUARY 20, 2023

The bottles of Starbucks' vanilla Frappuccinos may contain pieces of glass, the Food and Drug Administration said. (Image credit: Gene J.

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Containment Gene Drugs 144

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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

Clinical Research

Pharmaceutical Technology

FEBRUARY 20, 2023

ABN-401 is under clinical development by Abion and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how ABN-401’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Protein Clinical Trials Clinical Trials Drugs 100

NPR Health - Shots

FEBRUARY 20, 2023

Optometrists are lobbying for more leeway to treat patients — and physicians' groups are pushing back. But it's more than a turf war, both sides say, as they explain why patients' vision is at stake.

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Doctors Doctor 121

NPR Health - Shots

FEBRUARY 20, 2023

When his family fell into poverty, a young boy in Kenya found comfort and strength from video games. Now he's the country's gaming ambassador, a mentor to kids in the slums — and a firefighter.

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Pharmaceutical Technology

FEBRUARY 20, 2023

Esreboxetine is a small molecule commercialized by Axsome Therapeutics, with a leading Phase III program in Fibromyalgia (Fibromyalgia Syndrome). According to Globaldata, it is involved in 17 clinical trials, of which 11 were completed, and 6 were terminated. GlobalData uses proprietary data and analytics to provide a complete picture of Esreboxetine’s valuation in its risk-adjusted NPV model (rNPV).

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Sales Clinical Trials Clinical Trials Development 100

NPR Health - Shots

FEBRUARY 20, 2023

Two stroke patients regained control of a disabled arm and hand after researchers delivered electrical stimulation to their spines, paving the way toward a medical device that could aid movement.

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Research 110

Pharmaceutical Technology

FEBRUARY 20, 2023

Cavatak is an oncolytic virus commercialized by Merck, with a leading Phase II program in Transitional Cell Cancer (Urothelial Cell Cancer).

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

Clinical Trials

NPR Health - Shots

FEBRUARY 20, 2023

As children continue to navigate the most "normal" school year since the pandemic, 2023's School Counselor of the Year shares some advice.

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Pharmaceutical Technology

FEBRUARY 20, 2023

Felzartamab is a monoclonal antibody commercialized by I-Mab, with a leading Phase II program in IgA Nephropathy (Berger's Disease).

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Antibody 100

STAT News

FEBRUARY 20, 2023

As a physician caring for chronically ill individuals recently released from incarceration, I’ve become accustomed to working as a detective of sorts, trying to piece together the care they received while incarcerated in an attempt to recreate their medical histories and treatment plans. Since they are often released without medical records, prescriptions, and other lifesaving information, I ask questions like, “Do you remember your doctor’s name?

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Doctors Doctor 105

Pharmaceutical Technology

FEBRUARY 20, 2023

Epetraborole is a small molecule commercialized by AN2 Therapeutics, with a leading Phase III program in Mycobacterium avium Infections.

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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.

Clinical Supply

Medical Xpress

FEBRUARY 20, 2023

Analyzing the most extensive datasets in the United States, researchers from the Icahn School of Medicine at Mount Sinai have revealed that vaccination against COVID-19 is associated with fewer heart attacks, strokes, and other cardiovascular issues among people who were infected with SARS-CoV-2, the virus that causes COVID-19.

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Vaccination Vaccine Medicine Research 105

STAT News

FEBRUARY 20, 2023

Heather Rendulic yearns to use both hands to fill up her plate at a hotel buffet, or slice up her own steak. She wants to pull her hair into a ponytail. She’s tried to teach her husband, but it always comes out a bit messy. Almost nine years after a stroke paralyzed the left side of her body at age 23, Rendulic sat in a lab at the University of Pittsburgh and used her left hand to cut a steak.

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Medical Xpress

FEBRUARY 20, 2023

When we think of what makes athletes great, few of us would think that sleep might play an important role. But many of the world's best athletes say sleep is an essential part of their training routine and key in helping them to perform well.

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STAT News

FEBRUARY 20, 2023

Dan Brickey was stunned when he learned the news. The cost of the cystic fibrosis medicine that his 2-year-old daughter, Ali, had recently started taking was about to climb from just $180 out of pocket each year to a whopping $43,600 in 2023. The dramatic change was due to a decision by the drug’s manufacturer, Vertex Pharmaceuticals, to slash the amount of financial assistance that it offers to patients this year.

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Drugs Manufacturing Medicine 98

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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.

Clinical Trials

Medical Xpress

FEBRUARY 20, 2023

A unique study which involved 20 men lying in bed for two months straight, highlights the negative impact long-term inactivity places on the body's metabolic health, with implications for future space missions as well as life back on Earth.

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Intouch Solutions

FEBRUARY 20, 2023

EVERSANA INTOUCH is once again celebrating Black History Month this February! In addition to focused events and hearing from team members in live roundtable discussions, we opened the floor to Black colleagues about what this month means to them personally, Black historical figures they resonate with and more. Their gracious responses are below! Every February in the United States and Canada, October in some European countries, we pause and look back along the road of history in celebration and

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Nurses 98

Medical Xpress

FEBRUARY 20, 2023

For many children, winter season comes with regular exposure to circulating viruses at school or daycare. And a warm forehead is often one of the first clear signs a child has caught a bug.

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Medicine 98

Outsourcing Pharma

FEBRUARY 20, 2023

A survey conducted to understand whether supply issues over amoxicillin have persisted in the US found that an overwhelming majority of pharmacists are still struggling to source the commonly-used antibiotic.

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Drug Delivery Drugs 98

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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.

Clinical Supply

Medical Xpress

FEBRUARY 20, 2023

Dementia affects millions of Americans—including nearly one in 10 adults over age 65. While the causes of different dementias vary, a 2020 report from a Lancet commission identified several modifiable risk factors that together account for around 40% of dementia worldwide.

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BioPharma Reporter

FEBRUARY 20, 2023

In 2022, the European Medicines Agency (EMA) recommended 89 medicines for marketing authorization: including six advanced therapy medicinal products and eight biosimilars.

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Medical Xpress

FEBRUARY 20, 2023

Northwestern University researchers have developed the first smart wearable device to continuously track how much people use their voices, alerting them to overuse before vocal fatigue and potential injury set in.

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Pharma Times

FEBRUARY 20, 2023

Research concerns the effect of niraparib when combined with abiraterone acetate plus prednisone

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Research 123

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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.

Clinical Trials

Medical Xpress

FEBRUARY 20, 2023

Eleven top international addiction scientists argue that the 2022 statement on e-cigarettes issued by Australia's peak health and medical body, the National Health and Medical Research Council (NHMRC), fails to meet the high scientific standard expected of a leading national scientific body.

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NPR Health - Shots

FEBRUARY 20, 2023

Millions of Americans next month will see a decrease in federal food assistance. The Supplemental Nutrition Assistance Program benefits that were boosted during the pandemic are going away.

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Medical Xpress

FEBRUARY 20, 2023

Alternating hemiplegia of childhood is a severe neurodevelopmental disorder associated with a mutation in the ATP1A3 gene. It begins in infancy, causing symptoms that significantly impair quality of life. Young patients are affected by episodes of paralysis which can last from a few minutes to several days and involve one or alternating sides of the body.

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Gene 98

BioPharma Reporter

FEBRUARY 20, 2023

The partners will collaborate on a study of sustained drug delivery to the suprachoroidal space in the eye.

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Drug Delivery Drugs 98

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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.

Clinical Trials