Moderna, Merck data support claim of cancer vaccine’s promise
Bio Pharma Dive
APRIL 16, 2023
Data presented at AACR suggest a personalized shot made with messenger RNA may amplify the effects of a widely prescribed cancer immunotherapy.
Sat.Apr 15, 2023 - Fri.Apr 21, 2023
345 
US FDA makes EUA changes to Pfizer-BioNTech and Moderna Covid-19 vaccines
Pharmaceutical Technology
APRIL 19, 2023
The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5 strains can now be utilised for all doses administered to those aged six months and above.
Join 21,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Grand Rounds April 14, 2023: RECOVER in Action – Status of Clinical Trial Protocols (Kanecia Zimmerman, PhD, MD, MPH)
Rethinking Clinical Trials
APRIL 18, 2023
                                           Speaker Kanecia Zimmerman, MD, PhD, MPH Associate Professor of Pediatrics Duke Clinical Research Institute Duke University School of Medicine Slides Keywords COVID-19, RECOVER, Clinical Trials Key Points Long COVID is a set of multiple conditions with diverse clinical manifestations that can affect every major organ/tissue system, reflecting varied potential underlying and co-existing causes.
In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy
Fierce Pharma
APRIL 21, 2023
In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy aliu Fri, 04/21/2023 - 22:35
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Merck to buy inflammatory disease drugmaker Prometheus for $10.8B
Bio Pharma Dive
APRIL 16, 2023
The pharma has struck the sector’s second-largest buyout this year, announcing a deal for the developer of an inflammatory bowel disease treatment that’s shown promise in testing.
SAB secures FDA breakthrough therapy status for influenza immunotherapy
Pharmaceutical Technology
APRIL 19, 2023
SAB Biotherapeutics has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for SAB-176, an investigational immunotherapy to treat influenza. The newly granted status allows SAB to speed up the development and review of SAB-176, which is currently being studied for use in post-exposure prophylaxis for Type A and Type B influenza in high-risk patients, including those with anti-viral resistant strains.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
New injectable cell therapy could resolve osteoarthritis
Medical Xpress
APRIL 21, 2023
Wake Forest Institute for Regenerative Medicine (WFIRM) scientists have created a promising injectable cell therapy to treat osteoarthritis that both reduces inflammation and also regenerates articular cartilage.
J&J study data show dramatic benefit to multiple myeloma cell therapy
Bio Pharma Dive
APRIL 19, 2023
A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs.
Twist Bioscience and Astellas team up for antibody discovery
Pharmaceutical Technology
APRIL 21, 2023
Twist Bioscience and Astellas Pharma have entered a collaboration to help the latter to discover antibodies for immunotherapies. This is the third collaboration between the two companies. In May 2022, they signed a research partnership and exclusive option licence agreement for the development of antibodies to reduce tumour microenvironment-mediated immunosuppression.
Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations
Fierce Pharma
APRIL 19, 2023
Goodbye, original COVID-19 vaccines: FDA updates shot guidance, pulls monovalent authorizations zbecker Wed, 04/19/2023 - 11:04
As pandemic emergencies end, some patients with long COVID feel 'swept under the rug'
NPR Health - Shots
APRIL 19, 2023
Millions of Americans suffer from long COVID, which can have debilitating physical effects, including fatigue and difficulty breathing. Yet many patients feel abandoned, as federal aid winds down.
Startup Abdera raises $110M to fuel radiopharmaceutical research
Bio Pharma Dive
APRIL 20, 2023
The company, which previously raised $32 million in Series A funding, joins a growing list of new startups working to develop targeted radiation treatments.
Merck agrees to acquire Prometheus Biosciences for $10.8bn
Pharmaceutical Technology
APRIL 17, 2023
Merck has signed a definitive agreement to buy clinical-stage biotechnology firm Prometheus Biosciences for $10.8bn, strengthening its immunology pipeline. The company will buy all of Prometheus Biosciences’ outstanding shares for $200 a share through a subsidiary. Prometheus Biosciences uses precision medicine to discover, develop and commercialise new therapeutic and companion diagnostic products to treat immune-mediated diseases.
Brain images just got 64 million times sharper
Medical Xpress
APRIL 17, 2023
Magnetic resonance imaging (MRI) is how we visualize soft, watery tissue that is hard to image with X-rays. But while an MRI provides good enough resolution to spot a brain tumor, it needs to be a lot sharper to visualize microscopic details within the brain that reveal its organization.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
COVID during pregnancy may alter brain development in boys
NPR Health - Shots
APRIL 18, 2023
Boys born to mothers who got COVID-19 while pregnant seem to have a higher risk of subtle developmental delays, including those associated with autism spectrum disorder.
Merck’s latest deal turns up the spotlight on immune system drugmakers
Bio Pharma Dive
APRIL 17, 2023
The buyout of Prometheus highlights pharmaceutical companies’ intense interest in medicines targeting inflammatory diseases, according to analysts.
FDA pushes Daiichi Sankyo’s quizartinib approval date by three months
Pharmaceutical Technology
APRIL 21, 2023
The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. The PDUFA date was extended by three months to July 24, based on an April 20 company announcement.
New study confirms link between 'forever chemicals' in drinking water and weight gain
Medical Xpress
APRIL 19, 2023
A University of Rhode Island researcher has led a study that confirms a direct link between certain chemicals in drinking water and human obesity—specifically that increased PFAS content in blood promotes weight gain and makes it harder to keep a lower body weight after weight loss.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
One reason the push for diversity in medicine is lagging
NPR Health - Shots
APRIL 20, 2023
The U.S. desperately needs more Black and Hispanic doctors, research shows. But financial pressures and discrimination can keep young people from even applying to med school.
GSK to buy Bellus Health and its chronic cough drug for $2B
Bio Pharma Dive
APRIL 18, 2023
The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.
Hasten Biopharmaceutic raises $315m for pipeline assets development
Pharmaceutical Technology
APRIL 20, 2023
Chinese firm Hasten Biopharmaceutic has raised $315m for business development of its pipeline assets in a financing round co-led by Singapore-based CBC Group and Abu Dhabi sovereign wealth fund Mubadala Investment, The funding round was supported by additional institutional investors. Hasten will also use the proceeds from the round to fund future acquisitions.
No magic number for time it takes to form habits, finds new study
Medical Xpress
APRIL 17, 2023
Putting on your workout clothes and getting to the gym can feel like a slog at first. Eventually, you might get in the habit of going to the gym and readily pop over to your Zumba class or for a run on the treadmill. A new study from social scientists at Caltech now shows how long it takes to form the gym habit: an average of about six months.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Study: Black women should start breast cancer screening at age 42
STAT News
APRIL 19, 2023
For many years, there’s been considerable debate about the best age for women to initiate breast cancer screening.The U.S. Preventive Services Task Force recommends that women start getting screenings around age 50, while groups such as the American Cancer Society recommend screenings begin at an earlier age. Now a large new study suggests that if Black women begin screening for breast cancer at age 42, that could help lower racial disparities in breast cancer deaths.
French biotech pulls EMA application for eye disease gene therapy
Bio Pharma Dive
APRIL 21, 2023
With cash running low and a search for a buyer underway, GenSight wants advice from regulators on the type of data that would support an approval.
Moderna and IBM to explore quantum computing and AI for mRNA research
Pharmaceutical Technology
APRIL 21, 2023
Moderna has signed an agreement with IBM to explore quantum computing and generative artificial intelligence (AI) for advancing and expediting its mRNA research. Moderna will gain access to IBM’s quantum computing systems, an emerging technology that harnesses quantum mechanics for solving complex problems that cannot be handled efficiently by classical computers.
Disturbed sleep may partially explain long COVID breathlessness
Medical Xpress
APRIL 15, 2023
A major UK study has discovered that the disturbed sleep patterns in patients hospitalized with COVID-19 was likely to be a driver of breathlessness.
Discrimination lawsuit against HHMI spotlights barriers faced by scientists with disabilities
STAT News
APRIL 19, 2023
University of Michigan pediatric neurologist Vivian Cheung made a name for herself studying rare genetic diseases, and in 2008 — when she was on the faculty at the University of Pennsylvania — was hired as a Howard Hughes Medical Institute investigator, an honor for which she received $1 million a year over the next 12 years to further her research.
Appeals court sides with Amgen in patent fight over psoriasis drug Otezla
Bio Pharma Dive
APRIL 20, 2023
With the court victory, the biotech giant could stave off a set of generic competitors for the top-selling drug until 2028.
Incyte receives EC approval for Opzelura to treat non-segmental vitiligo
Pharmaceutical Technology
APRIL 21, 2023
Incyte has received marketing authorisation from the European Commission for Opzelura (ruxolitinib) cream 15mg/g to treat non-segmental vitiligo with facial involvement in adults and in adolescents aged 12 years and above. Opzelura is the first and only approved treatment across the European Union (EU) aimed at achieving repigmentation in the targeted patients.
Talking therapies linked with reduced risk of cardiovascular disease
Medical Xpress
APRIL 18, 2023
Effective management of depression through psychological therapy is associated with a lower likelihood of heart disease and stroke, according to research published today in European Heart Journal.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Let's personalize your content