Bio Pharma Dive
DECEMBER 30, 2022
An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline.
NPR Health - Shots
DECEMBER 30, 2022
The eye of the camera told the stories of kangaroo care for human babies, Angola's intrepid female de-miners, Ukrainian refugees who find a warm — and familiar — welcome in Brazil and more.
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STAT News
DECEMBER 30, 2022
The number of young people in the U.S. with type 2 diabetes could surge by about 700% over the next four decades, with a greater burden falling on minority groups, a new model predicts. If the recent acceleration of new diagnoses persists, then 220,000 people younger than 20 would have type 2 diabetes in 2060, compared with 28,000 in 2017, the latest year for which data is available, according to projections published this month in Diabetes Care.
NPR Health - Shots
DECEMBER 30, 2022
As case counts surge in China, rumors circulate about the effectiveness and safety of the made-in-China vaccines in use there. Here's what we know about CoronaVac and Sinopharm.
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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
Medical Xpress
DECEMBER 30, 2022
Ira Katz bustles at his pharmacy in Atlanta's Little Five Points neighborhood this cough season, serving patients who need medicine for respiratory viruses like COVID-19. He dispenses occasional packages of Paxlovid, a drug designed to nip COVID in the bud. But there aren't as many of those Paxlovid prescriptions as there might be.
STAT News
DECEMBER 30, 2022
Francesca Coleman, known to friends as “St. Louis,” has been unhoused since the age of 15. Now 24, Coleman sleeps in Tongva park, across from the famous Santa Monica pier in California. Like many unhoused people in the Los Angeles area, Coleman uses meth in an attempt to ease chronic pain, anxiety, and depression. On a Wednesday morning in July, physician Coley King checked in with Coleman in Tongva Park.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
DECEMBER 30, 2022
This year, STAT deepened its footholds in a number of coverage areas, from hospitals and insurance to reproductive health to health tech. Our staff also looked with admiration — and some envy — to many other journalists doing great reporting in these spaces. Below is our annual list of STAT staffers’ favorite stories of the year, and that we wish we had written.
Medical Xpress
DECEMBER 30, 2022
An international team of researchers including Sofya Kulikova, Senior Research Fellow at the HSE University-Perm, found that ketamine, being an NMDA receptor inhibitor, increases the brain's background noise, causing higher entropy of incoming sensory signals and disrupting their transmission between the thalamus and the cortex. This finding may contribute to a better understanding of the causes of psychosis in schizophrenia.
STAT News
DECEMBER 30, 2022
The Food and Drug Administration’s approval of Wegovy, Novo Nordisk’s latest obesity drug, for adolescents aged 12 years and older opens up a highly-anticipated tool in the fight against childhood obesity, but some doctors warn the sought-after medication isn’t a magic bullet. The move comes after the FDA approved Wegovy (semaglutide) for weight management in adults in 2021.
Medical Xpress
DECEMBER 30, 2022
Messenger RNA vaccine technology, once an arcane area of research, became household terminology because of the COVID-19 pandemic, and now scientists are working on an mRNA flu vaccine strategy that, at least in this study, involves a first dose administered as a shot but a booster administered as an mRNA nasal spray.
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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
DECEMBER 30, 2022
The vast majority of GPs are persuaded of the benefits of moving diagnostic services from the hospital to the community, according to a new survey of 200 GPs in the UK. Just 4% of would choose the hospital as the preferred location of testing, compared to 46% for the GP surgery, 18% for a community hub, 15% for a patient’s home and 12% for the pharmacy.
Medical Xpress
DECEMBER 30, 2022
If your infant or child is older than 6 months and has a fever, they probably do not need to be treated for the fever unless they are uncomfortable.
pharmaphorum
DECEMBER 30, 2022
Speaking with Rob Verheul, CEO of Graphite Digital, at Anthropy 2022 at the Eden Project, pharmaphorum web editor Nicole Raleigh enjoyed a minute discussing the event and what specifically had attracted Verheul to attend. Chatting about Graphite Digital’s role as a design specialist for HCPs, patient groups, and ‘everything in between’ – the vision and purpose that encircles that – Verheul and I look at the conversations being sparked at the event, the challenges that are clear across industries
Medical Xpress
DECEMBER 30, 2022
Independent risk factors for congenital hearing loss have been identified in newborns with congenital cytomegalovirus (cCMV) infection, according to a study published online Dec. 29 in JAMA Otolaryngology-Head & Neck Surgery.
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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
DECEMBER 30, 2022
They were pioneers in their fields, working to improve the health and lives of other women and paving the way for other female scientists.
Medical Xpress
DECEMBER 30, 2022
Acupuncture is safe and feasible for patients with irritable bowel syndrome with diarrhea (IBS-D), according to a pilot study published online Dec. 29 in JAMA Network Open.
NPR Health - Shots
DECEMBER 30, 2022
The opioid epidemic surged in 2022 — killing record numbers of Americans, but help may be on the way in the form of more aid to communities and major reforms in opioid addiction treatment.
Medical Xpress
DECEMBER 30, 2022
Passengers arriving at Spanish airports from China will be screened for COVID, Madrid's health minister said on Friday, following an explosion of cases in China.
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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.
pharmaphorum
DECEMBER 30, 2022
The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review. The document produced by Oversight and Reform Committee chair Carolyn Maloney (D-NY) and Energy and Commerce Committee chair Frank Pallone Jr (D-NJ) also points to “collaboration” between Biogen and the FDA ahead of an advi
Medical Xpress
DECEMBER 30, 2022
An analysis of tissue samples from the autopsies of 44 people who died with COVID-19 shows that SAR-CoV-2 virus spread throughout the body—including into the brain—and that it lingered for almost eight months. The study was published in Nature.
Drug Patent Watch
DECEMBER 30, 2022
Annual Drug Patent Expirations for RHOFADE Rhofade is a drug marketed by Epi Hlth and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Epi Hlth drug RHOFADE appeared first on DrugPatentWatch - Make Better Decisions.
Medical Xpress
DECEMBER 30, 2022
Researchers at The University of Texas MD Anderson Cancer Center have discovered a novel immunotherapy combination, targeting checkpoints in both T cells and myeloid suppressor cells, that successfully reprogrammed the tumor immune microenvironment (TIME) and significantly improved anti-tumor responses in preclinical models of pancreatic cancer.
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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.
Drug Patent Watch
DECEMBER 30, 2022
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Medical Xpress
DECEMBER 30, 2022
It's a sniffle, a tickle in the throat and a headache. Or a fever, congestion and fatigue.
Drug Patent Watch
DECEMBER 30, 2022
[—while others may go through long periods of watchful waiting. But for a small percentage of patients, the slower paced disease can transform into an aggressive cancer, called secondary acute myeloid leukemia, that has few effective treatment options.
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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.
Pharmaceutical Commerce
DECEMBER 30, 2022
The latest people news happenings over the past month.
Medical Xpress
DECEMBER 30, 2022
Orthopedic surgeons and biomedical engineers are trained to approach adolescent and young adult hip pain from two different perspectives. Surgeons typically look at conditions such as femoroacetabular impingement (FAI) and hip dysplasia from a clinical point of view. Engineers more often focus on the technology angle.
Drug Patent Watch
DECEMBER 30, 2022
This chart shows the pharmaceutical companies with the most patents in Slovakia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Slovakia? appeared first on DrugPatentWatch - Make Better Decisions.
Medical Xpress
DECEMBER 30, 2022
The American Academy of Pediatrics (AAP) clinical practice guideline (CPG) for management of well-appearing, febrile infants can help detect invasive bacterial infections (IBI) without using C-reactive protein (CRP) and procalcitonin (PCT) with high sensitivity but low specificity, according to a study published online Dec. 9 in Pediatrics.
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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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