This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
By Mark A. Tobolowsky & Charles G. Raver & James E. Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development.
Brainmachine interfaces (BMIs) have enabled a handful of test participants who are unable to move or speak to communicate simply by thinking. An implanted device picks up the neural signals associated with a particular thought and converts them into control signals that are fed into a computer or a robotic limb. For example, a quadriplegic person is asked to think about moving a cursor on a computer screen.
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!
Addressing the bottlenecks in cell and gene therapy manufacturing through a well-designed artificial intelligence approach is essential to avoiding data siloes.
There is a U-shaped association between alcohol consumption and coronary heart disease (CHD) and type 2 diabetes (T2D) but no evidence for a causal association, according to a study published online Nov. 24 in Alcohol: Clinical and Experimental Research.
There is a U-shaped association between alcohol consumption and coronary heart disease (CHD) and type 2 diabetes (T2D) but no evidence for a causal association, according to a study published online Nov. 24 in Alcohol: Clinical and Experimental Research.
Investment for companies developing cell and gene therapies (CGTs) was discussed during the GenScript Biotech Global Forum London 2024 conference held on 20 November 2024.
A breakthrough by researchers at Peter Mac will allow scientists to detect, analyze and profile cancer tumors in patients via a simple blood test. The Dawson lab at Peter Mac has developed a method that can take circulating tumor DNA (ctDNA) from the patient's blood and use an algorithm to identify cancer-related changes and patterns in their DNA.
According to a new study published in Nature Communications, researchers at the Department of Laboratory Medicine, Karolinska Institutet, have made a significant leap in drug discovery and development with a new method called CeTEAM. This approach connects how drugs bind to their targets inside cells with the effects they produce, offering a clearer understanding of how a drug works.
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
The development of an effective vaccine against the hepatitis C virus (HCV) has posed a significant challenge for decades due to the high genetic diversity of the virus. A research team has now achieved promising results. Using epitope-focused immunogens, they were able to induce broadly neutralizing antibodies (bnAbs) in laboratory models for the first time.
Researchers have discovered that astrocytes play an important role in regulating stress responses in the lateral septum in the brain. It is expected to provide new clues for mental health treatments.
Exactly why do people remember what they remember? A recently published review paper from researchers at Rice University sheds light on this fundamental question and the relationship between factors that influence human memory.
Cleveland Clinic Genome Center researchers have unraveled how immune cells called microglia can transform and drive harmful processes like neuroinflammation in Alzheimer's disease. The study, published in the journal Alzheimer's & Dementia, also integrates drug databases with real-world patient data to identify FDA-approved drugs that may be repurposed to target disease-associated microglia in Alzheimer's disease without affecting the healthy type.
A significant advance in breast cancer research has uncovered a key mechanism driving cancer invasion and drug resistance. A University of Liverpool study reveals how two critical molecules present in "HER2-positive" breast cancerone of the most aggressive formsinfluence breast cancer survival and its spread. The findings are published in the journal Science Advances.
Experts have used magnetic resonance imaging (MRI) to better understand the impact a gluten free diet has on people with celiac disease, which could be the first step towards finding new ways of treating the condition.
In the third part of this roundtable discussion, experts discuss the value of Michigan State Universitys Axia Instituteincluding its RFID testing effortsand dive into the Institutes end-to-end RFID pilot that it has been conducting.
The gut microbiota might perhaps one day become a routine tool for the early diagnosis of many diseases and to guide treatment, but at present there is a lack of solid scientific evidence to support these claims. Yet, day by day, there are more and more offers of commercial kits for do-it-yourself testing, at the moment totally lacking in meaning and scientific solidity.
As in most years that we've followed news reporting about the myth that suicides peak during the end-of-year holidays, an analysis of the past year showed again that more newspaper accounts supported the false idea that the suicide rate increases during the holiday season than debunked it.
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.
Kinevant Sciences, a unit in Roivant, announced that its Phase II RESOLVE-Lung study of namilumab, an investigational treatment for chronic active pulmonary sarcoidosis, did not meet its primary or secondary endpoints. Consequently, the company has decided to discontinue the development of the drug for this condition. This setback comes amid progress in Roivants broader clinical pipeline.
Research led by The Ohio State University Wexner Medical Center and College of Medicine along with scientists at the CharitUniversittsmedizin Berlin in Berlin, Germany, provides first evidence that hospital-acquired pressure ulcers are a potent risk factor for poor neurological recovery among patients with acute spinal cord injury (SCI).
In a landmark legal decision, precision oncology company Guardant Health has been awarded nearly $293 million in a false advertising trial against liquid biopsy test competitor, Natera. A jury in the US District Court for the Northern District of California was unanimous in favor of Guardant Health on all of its claims from its May 2021 lawsuit against Natera for false advertising and unfair competition.
Genicular artery embolization (GEA) is effective and safe for reducing osteoarthritis (OA) symptoms among patients with knee OA that is refractory to conservative therapy, according to a study presented at the annual meeting of the Radiological Society of North America, held from Dec. 1 to 5 in Chicago.
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
We organize all of the trending information in your field so you don't have to. Join 21,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content