Bio Pharma Dive
JANUARY 17, 2023
In a conversation at the J.P. Morgan Healthcare conference, the longtime Biogen executive discussed his hesitance to jump back into an executive role and why an opportunity to run Voyager Therapeutics drew him in.
Pharmaceutical Technology
JANUARY 17, 2023
Spain’s Hospital Universitario 12 de Octubre researchers, along with the Josep Carreras Leukaemia Research Institute, have developed a new cell therapy based on STAb cells to treat a type of leukaemia. The Spanish Association Against Cancer (AECC) provided funding for the new STAb therapy development. It could be used for T-Cell Acute Lymphoblastic Leukaemia (T-ALL) treatment in patients for whom bone marrow transplantation and chemotherapy failed to work.
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Bio Pharma Dive
JANUARY 17, 2023
Elicio’s combination with Angion Biomedica comes months after it abandoned a new stock offering, and is the latest example of how the IPO slowdown has shifted startups’ plans.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 17, 2023
To reduce the harmful health effects of sitting, take a 5-minute light walk every half-hour. That’s the key finding of a new study that my colleagues and I published in the journal Medicine & Science in Sports & Exercise. We asked 11 healthy middle-aged and older adults to sit in our lab for 8 hours […].
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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
Bio Pharma Dive
JANUARY 17, 2023
Digital innovation continues to transform the healthcare and biopharmaceutical landscape, and as it does, the role of Medical Affairs is changing.
Pharmaceutical Technology
JANUARY 17, 2023
Orphagen Pharmaceuticals has received a rare pediatric disease designation (RPDD) for OR-449 from the US Food and Drug Administration (FDA) to treat paediatric adrenocortical carcinoma (ACC). OR-449 is a first-in-class, orally bioavailable, potent and selective small molecule antagonist of the orphan nuclear receptor steroidogenic factor-1 (SF-1, NR5A1).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 17, 2023
The 72nd Indian Pharmaceutical Congress (IPC), to be held in Nagpur from January 20 to 22, will be attended by over 10,000 delegates from India and 150 from abroad. The number of delegates registered from foreign countries has crossed one hundred and it is expected that it will cross 150 by January 20. We are trying […].
Bio Pharma Dive
JANUARY 17, 2023
The pharma is now committing to providing all of the roughly 500 products in its portfolio, including antibiotics and cancer drugs, to 45 lower-income countries.
Pharmaceutical Technology
JANUARY 17, 2023
On January 12, Versanis Bio announced that enrollment had begun for its Phase IIb trial, BELIEVE (NCT05616013), which aims to study bimagrumab’s (BYM-338) efficacy and safety in the US, among other locations. Bimagrumab is of interest in the obesity space as it is a first-in-class therapy for obesity. In a previous Phase II trial (NCT03005288), which studied the effect of bimagrumab in obese or overweight patients with type 2 diabetes, fat loss exceeding 20% was demonstrated by week 48 of the st
Worldwide Clinical Trials
JANUARY 17, 2023
Ryan Gladden, our colleague and Black, Indigenous, People of Color (BIPOC) Employee Resource Group (ERG) member, shared his reflections on MLK Day. The post Reflections on Martin Luther King Jr. Day 2023 appeared first on Worldwide Clinical Trials.
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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
STAT News
JANUARY 17, 2023
Increased injection drug use has led to a spike in cases of the life-threatening heart condition endocarditis , with cases rapidly accelerating since the onset of Covid-19. The increased case count is one of the lesser-known side effects of the deadly addiction epidemic. But patients with endocarditis, an inflammation of the heart lining caused by infection, require complex, thoughtful care — care that the U.S. health system is ill-equipped to provide.
BioPharma Reporter
JANUARY 17, 2023
In 2022, the UK continued to have a signficant footprint in ATMP clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022, according to a new report.
STAT News
JANUARY 17, 2023
Moderna’s vaccine against the respiratory syncytial virus, or RSV, reduced the rate of lower respiratory disease in people over 60 in a Phase 3 trial, the company said Tuesday. The result will increase competition in a soon-to-be crowded market. The drug giants Pfizer and GlaxoSmithKline have already presented results for their RSV vaccines in older individuals, and have been preparing for what could be a brisk marketing battle.
NPR Health - Shots
JANUARY 17, 2023
Getting abortion medication online is easier than ever thanks to regulatory changes. The practice is pushing the boundaries of the traditional doctor-patient relationship.
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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.
Medical Xpress
JANUARY 17, 2023
The SARS-CoV-2 delta variant that caused the third wave of COVID-19 in mid-2021 turned out to be more contagious than earlier SARS-CoV-2 variants. In addition, protein mutations in the delta variant were found to significantly reduce the effect of acquired humoral immunity to COVID-19 from prior infection or vaccination.
STAT News
JANUARY 17, 2023
Catherine was getting nervous about her ADHD prescription. In 2022, the 29-year-old New Yorker had started using Done, a direct-to-consumer telehealth company that treats attention deficit hyperactivity disorder. The medication her provider had prescribed, a stimulant called Vyvanse, was helping her manage distraction so severe that she frequently had car accidents.
Medical Xpress
JANUARY 17, 2023
A first-of-its-kind study identifies mechanisms that explain how a drug commonly used to treat HIV and hepatitis causes kidney disease and kidney injury. The study is published ahead of print in Function.
STAT News
JANUARY 17, 2023
Two congressional committees recently released damning results of an 18-month investigation into the Food and Drug Administration’s approval of Biogen’s controversial Alzheimer’s drug, Aduhelm. The systems that enabled Biogen’s actions, however, went largely unscrutinized. The report listed extensive and serious concerns about Aduhelm’s rollout, including “atypical” interactions and collaboration between the FDA and Biogen; inappropriate use of th
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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.
Medical Xpress
JANUARY 17, 2023
An estimated ninety percent of deaths from breast cancer are due to complications resulting from metastasis, a process in which cancer cells break away from where they first formed, travel through the blood or lymph circulatory system, and form new, metastatic tumors in other parts of the body.
STAT News
JANUARY 17, 2023
More than two dozen big buyers of prescription medicines expect that prices will rise by an average of 8% annually over the next three years, a slight uptick from a year ago. And 19% believe that a “substantial portion” of the anticipated increases can be attributed to a shift to newer, pricier therapies, which is up from 8% a year ago, a new survey found.
Medical Xpress
JANUARY 17, 2023
Interleukin (IL)-11 is produced by inflammatory fibroblasts, one of the stromal cells, during acute colitis. Researchers at Toho University Japan found that IL-11 ameliorated acute colitis in mouse models. The IL-11 production was regulated by myeloid cells. These findings indicate that fibroblasts cooperate with myeloid cells to protect epithelial cells during colitis.
STAT News
JANUARY 17, 2023
SAN FRANCISCO — The last time Sana CEO Steve Harr was here for the J.P. Morgan Healthcare Conference, his company had only recently shrugged off the unprintable code name its founders used privately: FD Therapeutics, short for “F— Disease.” Little was known about the then-mysterious cell therapy startup, except that it would pursue ideas “ that will seem unconnected to the current reality ” and, rumor had it, potentially raise an over $1 billion Series A
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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.
NPR Health - Shots
JANUARY 17, 2023
Socially isolated older adults have a 27% higher chance of developing dementia, according to researchers from Johns Hopkins. The findings suggest that simple interventions could be meaningful.
STAT News
JANUARY 17, 2023
Most of the largest health plans in the U.S. generally provide “fair access” to 19 treatments for a handful of serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis found. Almost uniformly, the 18 health plans and benefit managers examined make the medications available fairly when judged on three criteria: prescriber restrictions, eligibility based on clinical data, and step therapy, which requires patients to try other med
BioPharma Reporter
JANUARY 17, 2023
Many life science professionals say they are âcautiously positiveâ about the outlook for their industry in 2023, although highlight it wonât be all plain sailing.
Fierce Pharma
JANUARY 17, 2023
CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. zbecker. Tue, 01/17/2023 - 11:49.
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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.
STAT News
JANUARY 17, 2023
In another bid to widen access to its medical products, Pfizer plans to provide roughly 500 medicines and vaccines — many of which are no longer protected by patents — at not-for-profit prices t0 45 mostly low-income countries. The goal is to make it possible for the countries to purchase the drugs and vaccines at substantially lower prices than they might otherwise.
NPR Health - Shots
JANUARY 17, 2023
Roe author Mary Ziegler has chronicled the legal, political and cultural battles around abortion, and says the debate is far from over: "We're at the very beginning of something very confusing.
pharmaphorum
JANUARY 17, 2023
Drugmaker AstraZeneca has teamed up with Indian digital health specialist Qure.ai and a clinical group in the UK to test an artificial intelligence-powered technology to help radiologists detecting lung cancer in chest X-rays. The aim of the pilot is to scan and review more than 250,000 images generated at clinics in the Greater Manchester Cancer Alliance, to see if Qure.ai’s qXR software can make faster and more accurate diagnoses of lung cancer.
STAT News
JANUARY 17, 2023
The Blueprint for an AI Bill of Rights the White House recently published didn’t come a moment too soon for the health care industry. The number of health care-related artificial intelligence models on the market has increased steadily over the past decade, with the health care AI market expected to grow from $7 billion today to $67 billion in 2027.
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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.
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