Pharmaceutical Technology
MARCH 21, 2023
Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.
Bio Pharma Dive
MARCH 21, 2023
Altimmune’s drug aided weight loss in a Phase 2 trial, but also came with side effects that could hamper its ability to compete with Novo Nordisk’s Wegovy.
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Pharmaceutical Technology
MARCH 21, 2023
Sanofi has secured approval for Dupixent (dupilumab) from the European Commission (EC) for the treatment of severe atopic dermatitis in children aged six months to five years, who are systemic therapy candidates, in the European Union (EU). This approval makes Dupixent the first and only medicine available in the US and Europe for the treatment of these young children.
Bio Pharma Dive
MARCH 21, 2023
The results, the first for a CAR-T therapy, are further evidence supporting the use of the complex therapies earlier in a patient’s disease course.
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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
Pharmaceutical Technology
MARCH 21, 2023
Gilead Sciences has exercised its option to exclusively license the investigational targeted protein degrader development candidate, NX‑0479, from clinical-stage biopharmaceutical company Nurix Therapeutics. The potent, selective, oral IRAK4 degrader named GS-6791 targets the scaffold and kinase functions of the IRAK4 protein kinase for blocking the pro-inflammatory IL1 cytokine family of receptors (IL1Rs) and inflammatory responses downstream of toll-like receptors (TLR).
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 21, 2023
The Pharmacy Council of India (PCI) has decided to extend the approval of existing courses for the academic year 2023-24 for the institutions which are approved by the Council, in the larger interest of the students and to maintain the timeline for the academic session.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
MARCH 21, 2023
Africa is grappling with not one, but two outbreaks of Marburg fever, a disease that causes symptoms and a death rate comparable to Ebola, its viral cousin. Health officials in Tanzania announced Tuesday that they had confirmed the country’s first-ever Marburg outbreak, involving at least eight people so far, five of whom have died. One of the people who died is a health care worker.
NPR Health - Shots
MARCH 21, 2023
GOOD Meat, which grows chicken and other meat from animal cells in a production facility, is the second company to cross this hurdle. The move brings no-kill meat closer to sale in the U.S. (Image credit: Brian L. Frank for NPR/Brian L.
STAT News
MARCH 21, 2023
Pills, patches, implants, and injections — the various forms of hormonal birth control have different formulations and doses of estrogen, progestin, or both. One might think, then, that they may have an unequal influence on breast cancer risk, but a new study in PLOS Medicine on Tuesday suggests that’s not so. The analysis found that most forms of hormonal birth control, regardless of their formulation, seem to confer roughly the same, small increase to breast cancer risk.
NPR Health - Shots
MARCH 21, 2023
The veterinary tranquilizer has been linked to a growing number of overdose deaths across the country, especially in the Northeast. It's often combined with fentanyl, but can't be treated with Narcan.
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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
MARCH 21, 2023
The path to payment for virtual reality companies working in health care just became slightly smoother. AppliedVR, a company targeting chronic pain, has become the first digital therapeutic to find an easy way to secure reimbursement from the Centers for Medicare and Medicaid Services. CMS granted AppliedVR a unique code for its flagship product, RelieVRx, and placed it in an existing benefit category: durable medical equipment.
NPR Health - Shots
MARCH 21, 2023
With a pandemic-era rule expiring this month, people on Medicaid will have to re-qualify to keep their coverage. Language barriers, housing instability and computer literacy could stand in their way.
STAT News
MARCH 21, 2023
The Covid pandemic exacerbated fear and panic regarding the potential for a future bioterrorism agent. As the lab leak theory continues to cause debate, politicians want to be able to tell their constituents that they are solving the problem by adding more oversight to biological research. But if all they are doing is adding more burden, bureaucracy, and box-checking, is it really making anyone more secure?
Medical Xpress
MARCH 21, 2023
New research from the University of Hertfordshire has found that a mobile-phone game app can help identify ongoing problems with navigation—a common long-term symptom of traumatic brain injuries (TBIs)—making these issues easier to diagnose and treat.
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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.
STAT News
MARCH 21, 2023
Patients beginning treatment for opioid addiction often face excruciating withdrawal symptoms. But for people struggling to transition from ultra-potent illicit fentanyl to comparatively weaker addiction medications, help may be on the way. A new federal regulation would make it easier for some patients to begin treatment on significantly higher doses of methadone , a key medicine used to treat opioid use disorder.
Medical Xpress
MARCH 21, 2023
New research has debunked the idea that there is an "obesity paradox," whereby patients with heart failure who are overweight or obese are thought to be less likely to end up in hospital or die than people of normal weight.
STAT News
MARCH 21, 2023
More than 200 civil society and patient advocacy groups are urging the U.K. government to remove the key negotiator working on a free trade agreement with the Indian government because of his previous ties to a major pharmaceutical company. A leaked version of the agreement already sparked concerns last year that the proposed deal would impede the supply of affordable generic medicines in poor countries around the world.
Medical Xpress
MARCH 21, 2023
Some of the lowest rates of heart and brain disease ever reported by science are found among Indigenous communities inhabiting the tropical forests of lowland Bolivia. New USC research on two of these societies, the Tsimané and Mosetén, suggests that there are optimal levels of food consumption and exercise that maximize healthy brain aging and reduce the risk of disease.
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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.
STAT News
MARCH 21, 2023
WASHINGTON — Moderna CEO Stéphane Bancel has some explaining to do. Bancel will appear alone before Sen. Bernie Sanders’ health committee on Wednesday, where he’ll have to defend his company’s suggestion it will likely quadruple the price of its Covid vaccines once sales transition from bulk federal purchases to the open market.
Medical Xpress
MARCH 21, 2023
In a new study, University of California, Irvine researchers found that exposure to the compound tetrahydrocannabinol (THC, a component of cannabis) at a young age could lead to depleted ovarian follicles and matured eggs in adulthood by nearly 50 percent.
STAT News
MARCH 21, 2023
STAT is reporting on the obstacles that prevent many Americans from accessing methadone and buprenorphine , two key medications used to treat opioid use disorder. People and organizations that sometimes make it difficult to access medication can include doctors, methadone clinics, health insurance companies, recovery groups, law enforcement agencies, jails, prisons, drug courts, and labor unions.
Medical Xpress
MARCH 21, 2023
An international study led by the Molecular Physiology Laboratory at the UPF Department of Medicine and Life Sciences (MELIS) identifies new genes that modulate the toxicity of the protein β-amyloid, responsible for causing Alzheimer's disease.
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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.
STAT News
MARCH 21, 2023
Giving doses of the steroid hydrocortisone to patients with severe pneumonia cut the risk of death by about half, according to a study released Tuesday. In the study, researchers funded by the French Ministry of Health randomly assigned 800 patients who had been placed in the intensive care unit to receive either hydrocortisone or a placebo. In the hydrocortisone group, about 6% of patients died within 28 days.
Medical Xpress
MARCH 21, 2023
President Joe Biden signed a bipartisan bill Monday that directs the federal government to declassify as much intelligence as possible about the origins of COVID-19 more than three years after the start of the pandemic.
STAT News
MARCH 21, 2023
A new obesity treatment being developed by Altimmune met goals for weight loss in a mid-stage clinical trial, but the data showed it doesn’t have a leg up on other popular drugs on the market. The drug, called pemvidutide, is part of a growing class of medications that target the GLP-1 receptor, mimicking the effects of a hormone that can help people feel full.
Medical Xpress
MARCH 21, 2023
New research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen, Denmark (April 15-18) reveals the high human costs and negative impacts of border restrictions and travel bans during the COVID-19 pandemic on citizens stranded abroad.
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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.
Drug Discovery World
MARCH 21, 2023
Pfizer and Astellas have announcesd positive top-line results from the Phase III EMBARK trial evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). Patients enrolled in the trial were randomised to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy.
Medical Xpress
MARCH 21, 2023
Anxiety sensitivity—the fear of anxiety-related sensations—has a long and not very healthy relationship with alcohol use and abuse. People who display high levels of AS are more likely to drink heavily and use alcohol as a coping method or to reduce tensions. For young adults, who drink the most, high AS can put them at risk for drinking to cope, which poses risks for long-term consequences on their personal and professional lives, including underemployment and addiction.
Drug Patent Watch
MARCH 21, 2023
Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are ten… The post New patent for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.
Medical Xpress
MARCH 21, 2023
While listening to a favorite song is a known mood booster, researchers at Michigan State University have discovered that music-listening interventions also can make medicines more effective.
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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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