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Trials of Xenotransplantation of Pig Organs into Humans Continue
Researchers have genetically engineered pigs to overcome the known barriers to transplantation of pig organs into humans, and have reached the stage of conducting transplants into terminally ill volunteers and brain dead individuals who donated their bodies to science. To learn by doing is really the only practical way by which the presently unknown problems are discovered. This trial of kidney transplantation ran for longer than prior efforts, and is a step on the path to producing a ready supply of non-human organs for transplantation, a technology that will compete with efforts to grow new organs on demands. Su...
Source: Fight Aging! - August 24, 2023 Category: Research Authors: Reason Tags: Daily News Source Type: blogs

Proprio Raises $43M Series B Funding to Fuel Commercialization
First Light Field-Enabled Surgical Technology Company Secures Additional Institutional Capital to Drive Adoption of its AI-Driven Platform Proprio, a Seattle-based surgical technology company, today announced that it has secured $43 million in Series B funding from new and existing investors. The capital fuels commercialization to address significant demand for Proprio’s AI-driven surgical navigation platform in the US and overseas. Proprio’s flagship surgical navigation platform, Paradigm™, achieved a significant milestone this year by obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA). ...
Source: EMR and HIPAA - August 17, 2023 Category: Information Technology Authors: Healthcare IT News Tags: Health IT Company Healthcare IT Alf Grunwald Bird B. AG FDA Gabriel Jones Health IT Funding Health IT Fundings Health IT Investment PARADIGM Proprio Source Type: blogs

What Is Pharmacology?
Credit: iStock. Pharmacology is the study of how molecules, such as medicines, interact with the body. Scientists who study pharmacology are called pharmacologists, and they explore the chemical properties, biological effects, and therapeutic uses of medicines and other molecules. Their work can be broken down into two main areas: Pharmacokinetics is the study of how the body acts on a medicine, including its processes of absorption, distribution, metabolism, and excretion (ADME). Pharmacodynamics is the study of how a medicine acts in the body—both on its intended target and throughout all the organs and tissue...
Source: Biomedical Beat Blog - National Institute of General Medical Sciences - August 14, 2023 Category: Research Authors: Chrissa Chverchko Tags: Being a Scientist Chemistry, Biochemistry and Pharmacology Common questions Genomics Medicines Miniseries Source Type: blogs

Neurotech, neuroethics and brain data in context: Are “neurorights” the way to mental privacy?
This article was originally published on The Conversation. To Learn More: Brain Data in Context: Are New Rights the Way to Mental and Brain Privacy? (AJOB Neuroscience). From the Abstract: The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy … To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows th...
Source: SharpBrains - August 10, 2023 Category: Neuroscience Authors: The Conversation Tags: Brain/ Mental Health Technology & Innovation brain data brain privacy Brain-Computer Interfaces contextual integrity mental privacy neural data neurotechnologies Neurotechnology Source Type: blogs

Connected Medical Devices —the Next Target for Ransomware Attacks
The following is a guest article by Ryan Witt, Healthcare Cybersecurity Leader at Proofpoint The Internet of Medical Things, or IoMT, is a deep web of interconnected devices that increasingly plays a vital role in care delivery. Unfortunately, these devices have also significantly enhanced healthcare’s cyber risk, and security researchers have raised alarms about the vulnerabilities of these devices for more than a decade. While we haven’t seen threat actors widely exploiting the vulnerabilities in the wild, it is only a matter of time—and the results of an event like an IoMT ransomware attack will be devastating to ...
Source: EMR and HIPAA - June 27, 2023 Category: Information Technology Authors: Guest Author Tags: Ambulatory C-Suite Leadership Health IT Company Healthcare IT Hospital - Health System IT Infrastructure and Dev Ops LTPAC Security and Privacy Consolidated Appropriations Act Cyber Risk Cybersecurity ECRI FDA Internet of Medical Source Type: blogs

Growing controversy over role of FDA and Medicare in promoting anti-amyloid drugs given limited benefit, high cost, severe side-effects
The War Over Whether Medicare Should Pay For The New Anti-Alzheimer’s Drugs (Forbers): The powerful Alzheimer’s Disease lobby is fighting a multi-billion-dollar battle on two fronts. It is quietly trying to limit restrictions the Food and Drug Administration puts on the use of new drugs aimed at slowing the progression of the brain disease. And it is publicly pressing Medicare to pay for the widespread use of the monoclonal antibodies FDA already has conditionally approved as well as others in the pipeline. While the FDA approves drugs for use, it doesn’t decide who pays for them. And, for now, the Centers for Medica...
Source: SharpBrains - June 21, 2023 Category: Neuroscience Authors: SharpBrains Tags: Brain/ Mental Health Alzheimer's experts Alzheimer’s Disease Anti-Alzheimer’s Drugs Biogen brain swelling Eisai europe FDA lecanemab Medicare Source Type: blogs

Sandoz/Gan & Lee Now Has Applications for Glargine, Lispro and Aspart Insulin Biosimilars on File with FDA, Expect them to come to market in early 2024.
Five years ago, back on December 19, 2018, Swiss pharmaceutical giant Novartis Pharma AG quietly issued a press release (seehttps://www.globenewswire.com/news-release/2018/12/19/1669194/0/en/Sandoz-enters-into-commercialization-and-supply-agreement-for-insulin-biosimilars-anticipating-growing-demand-as-diabetes-burden-rises.html for the release itself) on behalf of the company ' s business unit known as Sandoz. Specifically, Novartis said that its Sandoz generics unit planned to introduce biosimilars, or near-copy, versions of Sanofi ' s Lantus (glargine), Novo Nordisk ' s Novolog (aspart), and Eli Lilly ' s Humalog (lispr...
Source: Scott's Web Log - June 16, 2023 Category: Endocrinology Tags: 2023 Biosimilar biosimilars Gan & Lee insulin Sandoz Source Type: blogs

ONC ’s HTI-1 Places Undue Burdens on Healthcare Providers, Health IT Developers
The following is a guest article by David Bucciferro, Chair of the EHR Association In April 2023, the Office of the National Coordinator for Health Information Technology (ONC) released its much-anticipated proposed rule to advance interoperability, improve transparency, and support further access, exchange, and use of electronic health information (EHI). While the EHR Association has long supported the goals of the proposed rule, called Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule (HTI-1), we have a number of real concerns about...
Source: EMR and HIPAA - June 7, 2023 Category: Information Technology Authors: Guest Author Tags: Clinical EMR-EHR Health IT Company Healthcare IT Regulations Advanced Interoperability CDI Centers for Medicare and Medicaid Services Clinical Decision Support CMS David Bucciferro Decision Support Interventions DSI eHI EHR Ass Source Type: blogs

Connected Health Initiative – Our Health IT Friend on Capitol Hill
The Connected Health Initiative (CHI) is a non-profit organization that advocates on behalf of all health IT vendors. They are a trusted resource and voice for our industry so that policymakers at federal, state, and local levels can be better informed about emerging digital health technology. Vendors can help by contributing clinical efficacy studies to CHI’s new Digital Health Evidence Resource Database to bolster their advocacy efforts. Policymaking is a black box For most of us, the mechanism by which new laws are drafted, revised, and enacted on Capitol Hill is a black box…one that most do not wish to open. For a ...
Source: EMR and HIPAA - May 16, 2023 Category: Information Technology Authors: Colin Hung Tags: EMR-EHR Health IT Company Healthcare IT Brian Scarpelli CHI Connected Health Initiative Digital Health Evidence Resource Database Health IT advocacy healthcare guidelines Healthcare Policy Healthcare Regulations Healthcare Scene Feat Source Type: blogs

The Fall of FDA Review
Daniel G. Aaron (University of Utah), The Fall of FDA Review, Yale J. Health Pol ’y, L.& Ethics (2023): The U.S. Food and Drug Administration is in crisis. FDA can hardly go a single day without an investigation, news scoop,... (Source: HealthLawProf Blog)
Source: HealthLawProf Blog - May 12, 2023 Category: Medical Law Authors: Katharine Van Tassel Source Type: blogs

What ’ s Next For AI In Healthcare In 2023
We write tons of detailed articles about niche topics, for our seasoned audience. However, every now and then it is important to zoom out and just look at the big picture as well. Here we decided to provide a high-level outlook of what’s coming next for AI in healthcare, and hope it will be useful.  So let’s take a birds-eye view of what we can expect from AI in healthcare in the coming period. In this post, we will not discuss abstract principles but will instead focus on providing specific examples. By examining recent advancements and exploring potential future developments, we aim to provide a comprehen...
Source: The Medical Futurist - May 11, 2023 Category: Information Technology Authors: Andrea Koncz Tags: Artificial Intelligence in Medicine AI adaptive algorithm digital health AI in healthcare AI in medicine ChatGPT MedPaLM ChatGPT in healthcare AI in drug discovery Source Type: blogs

Info On What It Costs To Make Insulin API's Offshore (Courtesy of China's Gan & Lee Pharmaceuticals Ltd.)
When pharma companies refer to API ' s, they are referring to " Active Pharmaceutical Ingredients " (which is different from what an internet company means when they say API; to internet companies, the acronym API means " Application Programming Interface " ). Regardless, pharma API ' s are commonly made offshore in places like India, Malaysia, China and elsewhere because its cheaper for them and therefore helps their own bottom lines. Its unclear to me exactly how they manage issues including transporting the products across the world for some items which must be temperature-controlled, but if it fattens pharma ' s bottom...
Source: Scott's Web Log - May 1, 2023 Category: Endocrinology Tags: 2023 Biosimilar biosimilars BLA China COGS FDA Gan & Lee insulin Sandoz Source Type: blogs

FDA Approves Sculptra Injectable for Cheek Wrinkles
The U.S. Food and Drug Administration (FDA) in April approvedSculptra, an injectable poly-L-lactic acid, for the correction of cheek wrinkles. A popular dermal filler, Sculptra was first approved in 2004 and has long been used for facial rejuvenation, focusing primarily on restoring lost volume and combating sagging skin. According toDr. Hamori, the recent FDA approval for the correction of cheek wrinkles, " reinforces Sculptra ' s relevance, effectiveness and safety in the aesthetic injectable toolkit. ” Dr. Hamori has long used Sculptra to treat deep folds between the nose and mouth (or smile line), marionette lin...
Source: What's New In Plastic Surgery? - April 30, 2023 Category: Cosmetic Surgery Tags: injectables sculptra Source Type: blogs

South Korea-Based Undbio Co., Ltd. + Proprietary Insulin; Maybe Biosimilars (someday)
On April 13, 2023, a South Korean biopharmaceutical company known as Undbio Co., Ltd.http://undbio.com/eng/ signed a lease with West Virginia University to build what it refers to as an insulin " manufacturing facility " in the city of Morgantown, WV (seehttps://www.wvgazettemail.com/business/undbio-planning-insulin-facility-in-morgantown/article_6b986775-6a2e-5ce5-b312-c423d79cbda2.html for more information). In all likelihood, that will be for what pharma refers to as a " fill& finish " facility, rather than one where temperature-controlled bioreactors are located.Meanwhile, a nonprofit drug company known as Civica, ...
Source: Scott's Web Log - April 24, 2023 Category: Endocrinology Tags: 2023 morgantown west virginia wv mylan biosimilar insulin undbio Source Type: blogs