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Patient Dies in Gene Therapy Trial, But FDA Permits Neurogene to Proceed With Low Dose - MedCity News
A patient death in a clinical trial usually prompts the FDA to impose a clinical hold. But Neurogene is able to avoid a lengthy clinical trial pause largely because of its participation in an FDA pilot program intended to speed up the development of therapies for rare diseases.
Why the DOJ's Lawsuit Against the UGH-Amedisys Merger May Not Go Anywhere - MedCity News
Experts aren’t sure what the outcome of the DOJ’s recent lawsuit against the proposed UnitedHealth Group/Amedisys merger will be under the incoming Trump administration. The Biden administration has focused more on supporting clinicians, while the previous Trump administration favored corporations. Additionally, one expert noted that this case differs from other antitrust lawsuits because it does not seem to focus on a potential price increase.
Kura Oncology Gets $330M to Kick Off Global Leukemia Drug Pact With Kyowa Kirin - MedCity News
Kura Oncology already had a broad development plan for ziftomenib in leukemias, but the agreement with Kyowa Kirin provides the cash to execute it and a partner to commercialize the drug globally. Ziftomenib is in the same class of medicines as Syndax Pharmaceuticals’ Revuforj, which won FDA approval last week.
5 Healthcare CEOs React to Dr. Oz’s CMS Appointment - MedCity News
President-Elect Donald Trump nominated celebrity physician Dr. Mehmet Oz to lead CMS. Healthcare leaders have mixed feelings on the news — for instance, one CEO pointed out that Dr. Oz could advance the food-as-medicine movement, and others noted that his appointment may decrease pharmaceutical innovation and access to certain medications.
Strategies to Reduce Diagnostic Errors in Patient Care Settings - MedCity News
Reducing diagnostic error is a significant part of healthcare organizations’ efforts to improve patient outcomes. By using data to recognize vulnerabilities in the diagnostic process, empowering their diagnostic teams and fostering an environment where every team player understands their vital role organizations can proactively correct the potential root causes of diagnostic errors.
Eliminating Barriers and Increasing Access to New Testing to Improve Prenatal Care - MedCity News
New advancements can only be fully realized when clinicians, lawmakers, and patients come together. Biomarker tests not only have the potential to improve patient outcomes and address health equity, they can also decrease expenses for financially vulnerable medical systems.
Startup Valora Unveils a Sweet Way to Stop Cancer and Autoimmune Disease, Plus $30M for R&D - MedCity News
Valora Therapeutics’ antibody lectin chimeras, or AbLecs, target glyco-immune checkpoints, pathways that modulate cellular communication with the immune system. The startup’s science is based on research from Carolyn Bertozzi, a Stanford professor who was awarded the 2022 Nobel Prize in Chemistry.
Orion Innovations’ Light-Up Infusion Device Helps Both Patients and Nurses, Research Shows - MedCity News
A Utah-based startup named Orion Innovations released two studies this month demonstrating its product’s efficacy. The device attaches to hospital IV lines and uses a light to assist nurses with the identification and tracing of medication infusion lines, with the goal of reducing errors.
Polypharmacy is a Health Killer: Personalized Medication Management is the Answer - MedCity News
We cannot change the fact that some patients must take multiple drugs, but we can certainly change how we manage it with careful coordination and communication among healthcare providers, and personalized medicine practices such as pharmacogenomics.
Telehealth Advocates Praise DEA’s 3rd Extension of Telemedicine Flexibilities, but Call for Further Action - MedCity News
The DEA recently announced the third extension of Covid-19 flexibilities for the virtual prescribing of controlled substances. Telehealth advocates applaud this move but remain hopeful for a more permanent solution in the future.
Merck Gets a Shot of Confidence From Pivotal Test of SubQ Injectable Keytruda - MedCity News
Merck said topline Phase 3 results show an injectable version of Keytruda met the main goal of non-inferiority compared to the intravenously infused formulation that is the pharma giant’s top-selling product. Injectable Keytruda could help Merck compete against coming competition from biosimilars.
Ex-Invitae Spinoff Relaunches as Citizen Health, Picks Up $14.5M in Seed Funding - MedCity News
The Silicon Valley startup formerly known as Ciitizen relaunched as Citizen Health. The company seeks to empower patients with access to their complete health history — and it’s starting off by focusing on patients with rare diseases.
The Role of Clinical Collaboration Platforms in Enhancing Sepsis Care Workflows - MedCity News
While clinical collaboration platforms have already made a significant impact, there is still much work to be done to ensure that every hospital has the tools and protocols in place to respond to sepsis with the urgency it demands.
Why We Urgently Need More Widely Available Tests for Alzheimer’s Disease - MedCity News
Early diagnosis through blood tests buys invaluable time – for patients and their families to plan, seek support, make informed decisions about their difficult care journey and, perhaps most importantly, be together.
Syndax Pharmaceuticals Leukemia Drug Wins a First-in-Class FDA Approval - MedCity News
Approval of Syndax’s Revuforj for acute leukemia makes the twice-daily pill the first in a new class of drugs that block a cancer-driving protein called menin. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.
GSK Wagers $80M on a Tech Platform and Parkinson’s Drug from Flagship-Founded Vesalius - MedCity News
Vesalius Therapeutics’ AI-based technology finds novel targets and intervention points for subgroups of patients within a common disease. A small molecule that Vesalius has been developing for a novel Parkinson’s disease target is now headed to GSK, which has licensed global rights.
Revolutionizing Breast Cancer Survivorship Care: Early Detection and Prevention of Lymphedema - MedCity News
Our goal should be to make lymphedema a preventable aspect of cancer survivorship or at a minimum, manageable, rather than a debilitating aftereffect that diminishes patients' quality of life.
Remote Patient Monitoring Works ... What are Payers and Providers Waiting for? - MedCity News
To overcome challenges and ensure that RPM reaches its full potential, both providers and payers need to implement several key strategies — and technology is a key component to making everything easier on all organizations.
Merck Is Paying $588M for Potential Successor to Cancer Drug Juggernaut Keytruda - MedCity News
Merck is acquiring global rights to a bispecific antibody from LaNova Medicines that blocks two cancer targets, PD-1 and VEGF. The deal comes one day after BioNTech announced an $800 million acquisition that gives it full rights to a molecule in this hot class of cancer drug candidates.