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By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n
Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.
It comes down to discipline. That’s according to MIT Professor Li-Huei Tsai, a neuroscientist who focuses on diseases like Alzheimer’s and directs The Picower Institute for Learning and Memory. She told Insider that the keys to maintaining healthy brain function and memory as you age are no secret.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.
Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.
New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?
The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.
Regeneron Pharmaceuticals has collaborated with Sonoma Biotherapeutics to discover, develop and commercialise new regulatory T cell (Treg) therapies for autoimmune diseases. The partnership will combine the VelociSuite technologies of Regeneron with Sonoma Biotherapeutics’ pioneering approach to develop and produce gene modified Treg cell therapies.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Eyestem will be submitting data for approval of phase 2a first-in-human study for its product named as Eyesight RPE to the Drugs Controller General of India (DCGI) for dry age-related macular degeneration (AMD).
A pediatric surgeon and his colleagues at Vanderbilt University Medical Center had prepared for a mass casualty event, but the victims of Monday's shooting had already died by the time they arrived.
A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.
Vertex Pharmaceuticals has signed a new non-exclusive licensing agreement with CRISPR Therapeutics to expedite the development of its hypoimmune cell therapies to treat type 1 diabetes (T1D). Under the terms of the deal, the company will receive non-exclusive rights to CRISPR/Cas9, a gene-editing technology of CRISPR Therapeutics, for the development of potentially curative T1D cell therapies.
Indian healthcare providers and pharma companies pace up their efforts with early detection and research for new medicines to combat the spread of tuberculosis as drug resistance concerns emerge. TB is a significant public health threat, with an estimated 10 million annual cases. India shares the highest TB burden with 2.69 million cases and 4.
The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Lupus is a potentially life-threatening autoimmune disorder that disproportionately impacts women and communities of colour.
Indian pharma is now accelerating its pace towards interdisciplinary research for medicines to combat diseases. In this regard several collaborations for the integration of knowledge from different academic disciplines to address common complex problems that cannot be solved by any individual researcher from a single area of research are already underway.
After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.
A decade after a landmark report on Americans' shorter lives, the problem has only gotten worse. Unlike other wealthy nations, U.S. life expectancy has not bounced back from the pandemic.
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.
A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba
The first outbreak this year was in Equatorial Guinea, which has seen 20 deaths already. Now there are cases reported in Tanzania as well for this infectious disease with a high fatality rate.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc
The former venture arm of GSK had several of its portfolio companies get acquired or go public in the past year, overcoming a tough environment for young biotechs.
Built largely with Western donations, the spa-like retreat provides soldiers with counseling, aromatherapy and more. But most soldiers are there for no more than a week.
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