Bio Pharma Dive
JANUARY 26, 2023
The company’s drug Breyanzi led to remission in adults with chronic lymphocytic leukemia, a blood cancer for which CAR-T therapies aren’t yet approved to treat.
Pharmaceutical Technology
JANUARY 26, 2023
Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.
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Bio Pharma Dive
JANUARY 26, 2023
The biotech said one patient died after receiving an experimental antibody drug designed to deplete certain blood and bone marrow cells before a transplant.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 26, 2023
The Indian Council of Medical Research (ICMR) has issued Guidelines for Umbilical Cord Blood Banking: Collection, Processing, Testing, Storage, Banking and Release for Clinical Application (2023).
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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 26, 2023
The expert committee supported making primary and booster shots the same composition, while recommending periodic updates to better match the vaccines to circulating variants.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 26, 2023
There are already plenty of reasons to worry about COVID-19, but there’s another to add to the list: There’s evidence of the virus in fetal brain tissue in instances of pregnant people passing the infection to their children.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Mirror
JANUARY 26, 2023
by Dodie Guadines, Viseven Regional Director, APAC Region In 2022 the APAC pharmaceutical market was estimated at $40.25 billion. At the same time, Asia-Pacific pharma players expect their businesses to grow rapidly in the upcoming year. With an estimated CAGR of 10.5%, the APAC market is expected to reach a booming $64.96 billion by 2027. Within the region, the Indian market shows impressive success, responsible for 80% of anti-retroviral drugs and 50% of the global supply of vaccines.
STAT News
JANUARY 26, 2023
Fasten your seat belts, folks. We’re about to hit some turbulence. If you’re reading this, you’re interested in the discussion on the future of Covid-19 vaccination that’s going to take place today in a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. We at STAT can’t predict the outcome, but we know enough to expect that this meeting will feature some heated debate.
NPR Health - Shots
JANUARY 26, 2023
A new study finds that UV dryers for gel nail polish can damage DNA and mutate cells, confirming dermatologists' safety concerns. There are precautions you can take and alternatives to consider.
Medical Xpress
JANUARY 26, 2023
New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has established a blood-based test that could be used to predict the risk of Alzheimer's disease up to 3.5 years before clinical diagnosis.
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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
pharmaphorum
JANUARY 26, 2023
2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.
STAT News
JANUARY 26, 2023
WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons
Rethinking Clinical Trials
JANUARY 26, 2023
Speakers Mikhail Kosiborod, MD Vice President of Research Saint Luke’s Health System Professor of Medicine University of Missouri-Kansas City Slides Keywords Pragmatic Clinical Trials Key Points EVOLVE-MI is testing an important clinical hypothesis that aggressive LDL lowering for patients with atherosclerotic cardiovascular disease immediately after an acute coronary syndrome can actually improve patient outco
Medical Xpress
JANUARY 26, 2023
Diet trends come and go, but intermittent fasting, a form of dieting based around periods of non-eating followed by periods of concentrated eating, has somehow endured.
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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.
NPR Health - Shots
JANUARY 26, 2023
An NPR/Ipsos poll found widespread confusion on some basic facts about abortion and pregnancy. Can you answer the same questions correctly?
STAT News
JANUARY 26, 2023
A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.
Medical Xpress
JANUARY 26, 2023
A Rutgers University analysis of infants born to non-Hispanic Black and white mothers in the United States has found infants exposed to maternal smoking throughout pregnancy were more than five times as likely as infants of never-smokers to suffer a sudden unexpected infant death (SUID).
STAT News
JANUARY 26, 2023
Drugs like Wegovy and Ozempic are rapidly growing in popularity as weight-loss treatments. These medications contain semaglutide, a drug originally formulated to help people with diabetes control their blood sugar but also has shown to have a significant effect on appetite and is now also used for obesity. This video explains exactly how these drugs work in the body.
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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.
Fierce Pharma
JANUARY 26, 2023
BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30
STAT News
JANUARY 26, 2023
WASHINGTON — It’s not every day that the pharmaceutical industry, the NAACP, a cancer center, and a nonpartisan think tank are all lobbying to achieve the same policy goal. But an effort to expand Medicare coverage for obesity drugs has managed to unite them all, and many more groups across the health care industry, too.
Medical Xpress
JANUARY 26, 2023
People with poor literacy battle more mental health problems worldwide, according to new research from the University of East Anglia.
STAT News
JANUARY 26, 2023
The evolution of the coronavirus has knocked out another treatment. The Food and Drug Administration on Thursday withdrew the authorization of Evusheld, the latest antibody therapy to be rendered ineffective by the mutations the virus has picked up. Notably, Evusheld — unlike other antibody therapies — was not for infected patients, but rather was given as a pre-exposure treatment to people at high risk for severe Covid-19, such as those with compromised immune systems.
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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.
Medical Xpress
JANUARY 26, 2023
A study published today suggests the prevalence of long COVID was 36% among George Washington University students, faculty, staff and other members of the campus community who had tested positive for COVID-19 between July 2021 and March 2022. The study helps shed light and supports other research on this poorly understood condition in which even young, healthy adults can develop prolonged symptoms after infections with COVID-19.
STAT News
JANUARY 26, 2023
If the buzz is to be believed, ChatGPT seems poised to upend everything from high school essays and news articles to computer coding and scientific research. The program has generated huge interest for its ability to write nearly anything it’s asked to write and to answer questions. Microsoft has announced a “multiyear, multibillion dollar” investment — rumored to be as high as $10 billion — into its maker, the artificial intelligence company OpenAI.
NPR Health - Shots
JANUARY 26, 2023
Advisers to the U.S. Food and Drug Administration today endorsed a proposal to make big changes in the nation's approach to vaccinating people against COVID-19. (Image credit: Rogelio V.
STAT News
JANUARY 26, 2023
In her latest bid to address prescription drug prices, U.S. Sen. Elizabeth Warren (D-Mass.) is urging the U.S. Federal Trade Commission to “closely scrutinize” two pending pharmaceutical company mergers over concerns that “rampant consolidation” will drive up costs for consumers. One deal involves Amgen, which plans to pay $28.7 billion to acquire Horizon Therapeutics, a company that markets treatments for autoimmune disorders and recently generated takeover interest
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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.
Medical Xpress
JANUARY 26, 2023
Research in a mouse model of diet-induced obesity has found greater disruption to genes involved in heart function when coupled with vitamin A deficiency using a combined dietary and genetic approach. The study is published ahead of print in the American Journal of Physiology-Heart and Circulatory Physiology.
pharmaphorum
JANUARY 26, 2023
Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time. The document from the Prescription Medicines Code of Practice Authority (PMCPA) arrives in the wake of several cases where drugmakers made promotional statements on social media platforms – including LinkedIn and Instagram – that were deemed to have breached the code of practice laid down by the Association of British Pharmaceutical In
Medical Xpress
JANUARY 26, 2023
Disinhibition is one of the main symptoms of the behavioral variant frontotemporal dementia (bvFTD), a type of dementia associated with degeneration of the frontal and temporal lobes of the brain. Patients with bvFTD exhibit behaviors that are considered inappropriate, to the point that caregivers and family members may feel helpless.
NPR Health - Shots
JANUARY 26, 2023
After months of COVID, flu and RSV infections, parents of little kids are kinda losing it. But the data shows kids have always brought home waves of respiratory illness.
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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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