Bio Pharma Dive
FEBRUARY 21, 2024
The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drug developers must solve first.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 21, 2024
Approximately 1 in 26 people develop epilepsy, a condition in which someone experiences recurring and unprovoked seizures. But experiencing a seizure does not always mean a person has epilepsy. Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.
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Bio Pharma Dive
FEBRUARY 21, 2024
One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.
Pharmaceutical Technology
FEBRUARY 21, 2024
Biora’s new smart pill represents a new treatment modality that may increase the efficacy of therapeutics for ulcerative colitis
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
Worldwide Clinical Trials
FEBRUARY 21, 2024
During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure.
Bio Pharma Dive
FEBRUARY 21, 2024
The biotech alleges that the agency is letting competitor Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 21, 2024
The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.
Pharmaceutical Technology
FEBRUARY 21, 2024
Bavarian Nordic reported a preliminary revenue of $1bn for 2023, driven by sales of JYNNEOS, its moneypox/smallpox vaccine.
Bio Pharma Dive
FEBRUARY 21, 2024
The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.
Pharmaceutical Technology
FEBRUARY 21, 2024
Codeine linctus has been reclassified from a pharmacy-only medicine to a prescription-only medicine in the UK.
Rethinking Clinical Trials
FEBRUARY 21, 2024
In this Friday’s PCT Grand Rounds, Adrian Hernandez and Christopher Lindsell of Duke University will present “Virtual Vigilance: Monitoring of Decentralized Clinical Trials.” The Grand Rounds session will be held on Friday, February 23, 2024, at 1:00 pm eastern. Hernandez is the executive director of the Duke Clinical Research Institute (DCRI) and professor of medicine and vice dean in the Duke University School of Medicine.
Pharmaceutical Technology
FEBRUARY 21, 2024
A Phase I trial studying the therapy is underway after an FDA clinical hold was lifted last year, with initial data expected in 2024.
pharmaphorum
FEBRUARY 21, 2024
Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.
Pharmaceutical Technology
FEBRUARY 21, 2024
Polpharma’s biosimilar candidate PB106 showed non-inferiority to the reference therapy Takeda’s Entyvo in a Phase III trial.
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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
Fierce Pharma
FEBRUARY 21, 2024
On the heels of a turbulent 2023 in which Novavax’s very existence was at stake, the beleaguered vaccine maker has new reason to be optimistic about the future. | Novavax has reached a settlement with Gavi, the Vaccine Alliance ending arbitration tied to a 2021 advance purchase agreement around its prototype COVID-19 vaccine NVX-CoV2373. Had Novavax lost the arbitration, the company might have had to refund nearly $700 million.
Pharmaceutical Technology
FEBRUARY 21, 2024
Contract development and manufacturing organisation Genezen has announced plans to license CSL’s Cytegrity lentivirus production system.
Fierce Pharma
FEBRUARY 21, 2024
In a year that started with more than two-thirds of biopharma companies posting | While Novo Nordisk and Eli Lilly continued to be the biopharma industry growth leaders in the fourth quarter of 2023, many other drugmakers also delivered big gains, including Daiichi Sankyo, Amgen, Teva, GSK and Novartis.
Pharmaceutical Technology
FEBRUARY 21, 2024
WuXi ATU received FDA approval to commence the analytical examination and production of Iovance’s Amtagvi at its Philadelphia site.
pharmaphorum
FEBRUARY 21, 2024
Explore the evolution of clinical research in the UK, including the role of NIHR and Direct Delivery Teams in embracing new delivery models. Join our informative webinar to learn more.
Pharmaceutical Technology
FEBRUARY 21, 2024
The US FDA has approved Johnson & Johnson’s (J&J) reduced dosing frequency of TECVAYLI for relapsed or refractory multiple myeloma.
Fierce Pharma
FEBRUARY 21, 2024
Four major drugmakers are joining forces as they prepare to battle certain aspects of the Inflation Reduction Act (IRA) in court next month. | A federal judge in New Jersey agreed to let Bristol Myers Squibb, Novo Nordisk, Novartis and J&J present oral arguments together in their bid to challenge the government's new Medicare negotiations framework.
Pharmaceutical Technology
FEBRUARY 21, 2024
Bristol Myers Squibb (BMS) reported FDA acceptance of the sNDA for KRAZATI plus cetuximab to treat colorectal cancer for priority review.
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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.
Pharma Times
FEBRUARY 21, 2024
Results showed robust responses in patients with pancreatic and colorectal cancer
Fierce Pharma
FEBRUARY 21, 2024
Joseph Papa has reemerged nearly a year after stepping down as head honcho of Bausch + Lomb. | Joseph Papa has re-emerged nearly a year after stepping down as head honcho of Bausch + Lomb. The former Valeant helmsman is now tasked with turning around Emergent BioSolutions as its new CEO.
Pharmaceutical Commerce
FEBRUARY 21, 2024
Cabenuva (cabotegravir + rilpivirine) showed superior efficacy in maintaining viral load suppression in patients with HIV compared with standard of care daily oral antiretroviral treatment.
pharmaphorum
FEBRUARY 21, 2024
Attention-deficit hyperactivity disorder (ADHD) in adults is not well understood and highly underdiagnosed, but the developers of a mobile game designed to raise awareness hope to shine a light on the struggles of people struggling with the condition.
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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
Fierce Pharma
FEBRUARY 21, 2024
Following the exodus of several prominent drugmakers and some surprising drug pricing setbacks in Washington, the influential industry lobbying group PhRMA has been busy navigating new challen | PhRMA revealed that Gilead CEO Daniel O’Day has donned the mantle as chair of the board of directors, replacing Novartis chief Vas Narasimhan, who held the position for much of 2023.
pharmaphorum
FEBRUARY 21, 2024
United sues FDA for allowing a marketing application for a competitor to its top-seller Tyvaso, filed by Liquidia, that sidesteps established procedures
Outsourcing Pharma
FEBRUARY 21, 2024
This week Univo IRB was announced as the new company name for Principal IRB.
pharmaphorum
FEBRUARY 21, 2024
FDA and EMA start speedy reviews of Servier’s vorasidenib for IDH-mutated low-grade glioma, hoping to end decades of stagnation in therapies for the brain cancer.
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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.
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