Bio Pharma Dive
SEPTEMBER 18, 2023
Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.
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Worldwide Clinical Trials
SEPTEMBER 20, 2023
Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi
Rethinking Clinical Trials
SEPTEMBER 20, 2023
In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.” The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern. Coker is the chief of general pediatrics and a professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s Hospital.
Bio Pharma Dive
SEPTEMBER 19, 2023
AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.
Pharmaceutical Technology
SEPTEMBER 21, 2023
The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 17, 2023
After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.
Bio Pharma Dive
SEPTEMBER 19, 2023
Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.
Fierce Pharma
SEPTEMBER 21, 2023
Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Antidote
SEPTEMBER 22, 2023
Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.
Bio Pharma Dive
SEPTEMBER 20, 2023
Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.
Pharmaceutical Technology
SEPTEMBER 19, 2023
The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.
Fierce Pharma
SEPTEMBER 19, 2023
Novo Nordisk’s shares continued to trend downward Tuesday after reports surfaced that the FDA had recently flagged manufacturing shortfalls at the Danish drugmaker’s Clayton, North Carolina product | After inspecting Novo’s Clayton, North Carolina, facility between July 6 and July 13, 2023, the FDA officially chided the company for a pair of quality control lapses, according to a Form 483 seen by Fierce Pharma.
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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.
Pharma Times
SEPTEMBER 18, 2023
The treatment is the first oral GPCR receptor antagonist class recommended for NHS use - News - PharmaTimes
Bio Pharma Dive
SEPTEMBER 18, 2023
With the rise of ChatGPT and artificial intelligence (AI), there are many ways the clinical staffing industry can use AI advantageously while removing the stigma that the rise of technology can be dehumanizing.
Pharmaceutical Technology
SEPTEMBER 19, 2023
Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.
Fierce Pharma
SEPTEMBER 22, 2023
Fast on the heels of winning a European approval to treat chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim's versatile SGLT2 inhibitor Jardiance is expanding its reach in the U.S., | After AstraZeneca's Farxiga won a class-first chronic kidney disease approval back in 2021, Eli Lilly and Boehringer are entering the fray with their SGLT2 drug Jardiance.
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.
Antidote
SEPTEMBER 21, 2023
Antidote’s podcast, Talk of the Towne , hosted by Antidote’s Senior Clinical Informatics Manager, Dr. Richard Towne, is an interview series featuring members of Antidote's partner network. During each episode, Rich and his guests take a closer look at particular therapeutic areas, the latest research developments, and specific pain points that impact the patient population.
Bio Pharma Dive
SEPTEMBER 18, 2023
Three years after gaining European approval, Libmeldy is now under U.S. review with a deadline set for March.
Pharmaceutical Technology
SEPTEMBER 18, 2023
The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.
Fierce Pharma
SEPTEMBER 20, 2023
After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.
BioSpace
SEPTEMBER 21, 2023
In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.
Bio Pharma Dive
SEPTEMBER 18, 2023
The drug, known scientifically as momelotinib, is now cleared to treat myelofibrosis and will compete against rival medicines sold by Incyte and Bristol Myers Squibb.
Pharmaceutical Technology
SEPTEMBER 22, 2023
JURA Bio has entered into a research collaboration with Replay cell therapy product company Syena for the development of TCR based therapies.
Fierce Pharma
SEPTEMBER 20, 2023
Positive FDA advisory committee votes aren’t always a blueprint for approval. | Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.
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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.
XTalks
SEPTEMBER 20, 2023
This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.
Bio Pharma Dive
SEPTEMBER 22, 2023
Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.
Pharmaceutical Technology
SEPTEMBER 18, 2023
Despite major shifts in the IBD landscape, most approaches that go beyond targeting inflammation remain in the earlier stages of development.
Fierce Pharma
SEPTEMBER 18, 2023
With the loss of elasticity in the skin that accompanies aging, platysma bands can become more apparent, protruding from the neck. | Already approved as an injection to reduce wrinkles in the forehead and around the eyes, AbbVie's Botox is in position to expand its cosmetic uses to the moderate to severe form of platysma prominence, a condition which causes muscle bands to protrude from the neck.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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