Bio Pharma Dive
FEBRUARY 3, 2023
The biotech recently stopped a trial of its experimental conditioning regimen over safety concerns. Now it’s halting further development work as it undertakes a strategic review.
Pharmaceutical Technology
FEBRUARY 3, 2023
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.
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Bio Pharma Dive
FEBRUARY 3, 2023
The company, which worked with GSK to develop a coronavirus shot, is ceasing operations after its corporate parent cut off further investment.
Pharmaceutical Technology
FEBRUARY 3, 2023
Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.
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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
FEBRUARY 3, 2023
Among the drugs Roche recorded impairment charges on are four gene therapies acquired in the company's 2019 deal for Spark Therapeutics.
Pharmaceutical Technology
FEBRUARY 3, 2023
Biologic therapies are a mainstay in the management of various immunology indications, including rheumatoid arthritis (RA), psoriasis (PsO), axial spondyloarthritis (axSpA), atopic dermatitis (AD), Crohn’s disease (CD), and ulcerative colitis (UC), and serve as the key growth drivers in terms of commercial value in these indications. AbbVie’s Humira (adalimumab) has been a blockbuster drug on this front across several of the aforementioned diseases.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 3, 2023
Karuna Therapeutics has entered an exclusive licence agreement with Goldfinch Bio for investigational transient receptor potential canonical 4 and 5 (TRPC4/5) channel candidates. Karuna signed the deal with GFB, the assignee of the Goldfinch Bio assignment estate. Under the deal, Karuna will have an exclusive worldwide licence for the development, manufacturing, and commercialisation of multiple Goldfinch Bio’s TRPC4/5 candidates, including GFB-887, the lead clinical-stage candidate.
Medical Xpress
FEBRUARY 3, 2023
Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.
NPR Health - Shots
FEBRUARY 3, 2023
The main reason the surge is ebbing now, pandemic experts suspect, is the significant immunity many people in the U.S. have acquired from prior infections and COVID vaccinations many received.
Fierce Pharma
FEBRUARY 3, 2023
J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29
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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
NPR Health - Shots
FEBRUARY 3, 2023
EzriCare artificial tears are suspected to be the cause of an outbreak of the VIM-GES-CRPA strain of Pseudomonas aeruginosa, which the CDC said is the first outbreak of its kind in the U.S.
STAT News
FEBRUARY 3, 2023
The Federal Trade Commission took aim at prescription drug coupon site GoodRx this week in an early attempt to crack down on the unfettered sharing of consumers’ health data for advertising. It was the first time the agency had gone after such a health data violation. But with the vast amounts of patient information now being mined and shared online, it’ll be far from the last.
Medical Xpress
FEBRUARY 3, 2023
A recent study from UiB shows that elevated plasma methylmalonic acid predicts increased risk of acute myocardial infarction and mortality in patients with suspected or verified coronary heart disease.
STAT News
FEBRUARY 3, 2023
A Turkish court overturned a decision by the national antitrust regulator that two years ago fined Roche and Novartis more than $30 million for conspiring to spread misinformation about an eye treatment, a rare victory for the companies after legal setbacks elsewhere. In response to appeals filed by both drugmakers, an administrative court in Ankara, Turkey, determined that the Turkish Competition Board failed to demonstrate that Novartis and Roche colluded illegally to promote the eye medicatio
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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
FEBRUARY 3, 2023
A race-based adjustment to test-result values from a common prenatal screening should be discontinued, according to a study published this week in Obstetrics and Gynecology. The adjustment has historically been applied only with Black women.
STAT News
FEBRUARY 3, 2023
Layoffs in the tech sector — think Google, Amazon, Meta, and the like — from jobs once thought to be secure and prestigious are making headlines. I’ve been seeing an outpouring of media coverage, including support extended toward newly unemployed tech workers, judgements passed on tech leaders, practical suggestions of opportunities , and analyses of underlying causes and next steps.
Medical Xpress
FEBRUARY 3, 2023
Australia's drugs watchdog on Friday announced that psychedelic substances MDMA and psilocybin—more commonly known as ecstasy and magic mushrooms—will soon be used in the treatment of depression and post-traumatic stress.
STAT News
FEBRUARY 3, 2023
A blistering battle has broken out between the ALS Association and more than a dozen of its state and local chapters, which are resisting a move by the national headquarters to dismantle their offices and run operations around the U.S. Fifteen chapters claim the national office is attempting the takeover in order to grab a larger share of revenue these local offices send to association headquarters, according to a lawsuit filed in a Delaware state court.
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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
FEBRUARY 3, 2023
A Mater Research study has identified a previously unknown genetic link between platelets and Parkinson's Disease, with findings published in Cell Genomics.
STAT News
FEBRUARY 3, 2023
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Medical Xpress
FEBRUARY 3, 2023
For the first time, a study examined perceived neighborhood walkability, physical activity, and obesity indicators on a national level, finding that people who lived in walkable neighborhoods were more likely to be physically active and have lower BMIs—but this association differed among Black, Hispanic, and Asian populations.
STAT News
FEBRUARY 3, 2023
The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Certification by the Food and Drug Administration that these products are safe and useful against many common ailments could unleash a $60 billion annual market by 2030.
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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
FEBRUARY 3, 2023
A research team from LKS Faculty of Medicine, the University of Hong Kong (HKUMed) discovered that somatic deletion of a tumor suppressor gene AKTIP promotes luminal breast cancer development and resistance to endocrine therapy. The findings are now published in Cell Reports.
STAT News
FEBRUARY 3, 2023
Vertex Pharmaceuticals revolutionized the treatment of cystic fibrosis. It also has unfinished business. The Boston drugmaker’s medicines for the genetic disease — which damages the lungs and other organs — have transformed the lives of patients, helping them abandon other time-consuming treatments, shrug off what would have been dangerous respiratory infections, and just live breathing easier.
Medical Xpress
FEBRUARY 3, 2023
The Strategic Memory Advanced Reasoning Tactics (SMART) brain health training protocol has been shown to improve symptoms of depression, anxiety and stress when delivered in person. New research from Center for BrainHealth at The University of Texas at Dallas demonstrates the effectiveness of online delivery of SMART.
STAT News
FEBRUARY 3, 2023
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to catch up on our reading, stroll about with our official mascot, and, given the frigid weather in our neighborhood, stay indoors to hold another listening party with Mrs.
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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.
XTalks
FEBRUARY 3, 2023
The US Food and Drug Administration (FDA) has approved the first and only oral drug for the treatment of advanced or metastatic breast cancer in postmenopausal women or adult men with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) ESR1 mutations. Orserdu (elacestrant) is the first endocrine innovation in 20 years specifically targeting ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer patients with disease progression following at leas
Medical Xpress
FEBRUARY 3, 2023
Childhood trauma may play a key role in many later psychiatric disorders. However, most of what we know about the impact of trauma exposure comes from research with adults.
Pharma Times
FEBRUARY 3, 2023
Partnership involves the study of real-time patient data and identification of adherence issues
Medical Xpress
FEBRUARY 3, 2023
Over the past year, cities across the United States have unveiled new policy plans to address homelessness amid rising concerns about health and crime—for homeless people themselves, as well as for surrounding communities. Notably, several proposals include civil commitment, also referred to as involuntary treatment, for people with severe mental illness or substance use disorders.
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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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