STAT News

FEBRUARY 26, 2023

On Friday, the Food and Drug Administration issued an emergency authorization for the first at-home test that can detect flu and Covid-19 — but for the test’s maker, Lucira, the long-anticipated authorization may have taken too long. The company filed for bankruptcy on Feb. 22, directly blaming the “protracted” FDA authorization process for the over-the-counter combination test for its financial troubles.

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Manufacturing Drugs 132

NPR Health - Shots

FEBRUARY 26, 2023

New research found teens and young adults who even briefly cut time on social media gained self esteem. Try these 5 tips to help them — and yourself — improve screen-life balance.

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Research 129

Pharmaceutical Technology

FEBRUARY 26, 2023

Dezapelisib is under clinical development by Incyte and currently in Phase I for Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase I drugs for Chronic Lymphocytic Leukemia (CLL) have a 71% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dezapelisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Pharmacy Drugs Development Clinical Trials 100

Medical Xpress

FEBRUARY 26, 2023

It's long been known that being overweight or obese can make a person more apt to develop conditions like high blood pressure or diabetes, which can lead to cardiovascular disease. But experts at Mayo Clinic say obesity also can affect the heart in entirely independent ways.

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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 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. According to GlobalData, Phase I drugs for Metastatic Colorectal Cancer have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CUE-102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Drugs Clinical Trials Clinical Trials Development 100

Cloudbyz

FEBRUARY 26, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports. Regulatory agencies, such as the FDA or EMA, may inspect the TMF as part of their oversight of clinical trials to ensure compliance with applicable regulations and guidelines.

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Clinical Trials Clinical Trials Compliance Trials 89

Medical Xpress

FEBRUARY 26, 2023

If you get health care coverage through Medicaid, you might be at risk of losing that coverage over the next year.

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Pharmaceutical Technology

FEBRUARY 26, 2023

Dezapelisib is under clinical development by Incyte and currently in Phase I for Hairy Cell Leukemia. According to GlobalData, Phase I drugs for Hairy Cell Leukemia have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Dezapelisib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

Pharmacy 100

Pharmacy Drugs Development Clinical Trials 100

Medical Xpress

FEBRUARY 26, 2023

Black people are receiving medications for dementia less often than white people, according to a preliminary study released today, February 26, 2023, that will be presented at the American Academy of Neurology's 75th Annual Meeting being held in person in Boston and live online from April 22-27, 2023.

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Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. According to GlobalData, Phase I drugs for Gastroesophageal (GE) Junction Carcinomas have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how CUE-102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Drugs Clinical Trials Clinical Trials Development 100

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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

BioSpace

FEBRUARY 26, 2023

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS 2/27/2023

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Medical Xpress

FEBRUARY 26, 2023

Chronic pain impacts around 20 percent of the population. Along with the medical and physical effects it can have far-reaching consequences for employment, lifestyle and mental health.

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BioSpace

FEBRUARY 26, 2023

Billy Dunn Steps Down from Post as FDA Neuroscience Head 2/27/2023

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JAMA Internal Medicine

FEBRUARY 26, 2023

This Viewpoint suggests that professional societies should continue to advocate for equitable access for patients to all necessary medical care including abortion care.

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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

BioSpace

FEBRUARY 26, 2023

Fulcrum’s Clinical Hold Highlights Tough Road in Sickle Cell Space 2/27/2023

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Roots Analysis

FEBRUARY 26, 2023

Over the last two decades, the pharmaceutical industry has observed a paradigm shift from conventional drug delivery strategies to the long-acting drug delivery (LADD) of products to treat several disease indications, such as ophthalmic disorders, oncological disorders, neurological disorders and infectious diseases. LADD has emerged as the novel and advanced drug delivery system which manipulate the dosing regimen of the drug in the body in order to sustain its therapeutic level.

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BioSpace

FEBRUARY 26, 2023

FDA Action Alert: Cytokinetics, Reata, Regeneron, Pfizer and GSK 2/27/2023

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JAMA Internal Medicine

FEBRUARY 26, 2023

This cohort study uses the American Heart Association’s Life’s Essential 8 metrics to quantify the associations between levels of cardiovascular health and life expectancy free of major chronic disease, including cardiovascular disease, diabetes, cancer, and dementia, among UK adults.

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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

BioSpace

FEBRUARY 26, 2023

Pay Transparency Backlash: the Harm of Reluctant Compliance 2/27/2023

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Compliance 93

Pharmaceutical Technology

FEBRUARY 26, 2023

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times.

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Bacteria Trials Research Medicine 278

BioSpace

FEBRUARY 26, 2023

The ALS Puzzle Gets Two New Pieces: SYF2 and PIKFYVE 2/27/2023

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Drug Patent Watch

FEBRUARY 26, 2023

This chart shows the pharmaceutical companies with the most patents in South Korea. Patents must be filed in each country (or, in some cases regional patent office) where patent protection… The post Which pharmaceutical companies have the most drug patents in South Korea? appeared first on DrugPatentWatch - Make Better Decisions.

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Drugs 40

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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

BioSpace

FEBRUARY 26, 2023

Seagen has a New Suitor as Pfizer Talks Begin: WSJ 2/27/2023

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Pharmaceutical Technology

FEBRUARY 26, 2023

EDP-1815 is under clinical development by Evelo Biosciences and currently in Phase II for Plaque Psoriasis (Psoriasis Vulgaris). According to GlobalData, Phase II drugs for Plaque Psoriasis (Psoriasis Vulgaris) have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how EDP-1815’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Development Clinical Trials Clinical Trials Drugs 100

Pharma in Brief

FEBRUARY 26, 2023

Higher costs awards for Federal Court litigation are on the horizon, with the Canadian government consulting on proposed amendments to the costs structure in the Federal Courts Rules (the Rules ). The proposed amendments are intended to increase costs awards by approximately 25%. The current costs regime Under the Rules , the Federal Courts can fix a costs award by following a tariff structure or by issuing a lump-sum award.

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