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A new publication from the FDA Oncology Center of Excellence (OCE) and the ClinicalTrials Transformation Initiative (CTTI), published in the Clinical Cancer Research journal, provides important insights into how decentralized clinicaltrial (DCT) elements were used in cancer trials leading to FDAapproval during the COVID-19 pandemic.
PTC Therapeutics has gained US Food and Drug Administration (FDA) approval for its new gene therapy, Kebilidi (eladocagene exuparvovec), for treating aromatic L-amino acid decarboxylase (AADC) deficiency. The FDA also authorized the SmartFlow Neuro Cannula, a specialized infusion device by ClearPoint Neuro, Inc.,
The US Food and Drug Administration (FDA) on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer’s disease.
Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.
SUMMARY: Over half of all clinicaltrial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinicaltrial enrollment it really depends on the condition and risk as judged by the patient. According to antidote.com. No, not at all.
Research suggests that certain bacteria, particularly those associated with Demodex mites (tiny mites that naturally live on human skin) like Bacillus oleronius , could contribute to rosacea in some individuals. Emrosi’s approval was based on data from a pair of Phase III clinicaltrials for the treatment of rosacea.
Trends in Psoriasis Research: Biologics, Biosimilars and New Therapies Recent innovations in biologics and biosimilars have transformed psoriasis care. The Psoriasis Diet Diet has long been an area of research as a potential factor in managing psoriasis.
XTALKS WEBINAR: Keys to Success in ClinicalTrials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinicaltrials and accelerate their path to drug approval.
November is Pancreatic Cancer Awareness Month , a time dedicated to increasing public understanding of this challenging disease, supporting patients and their families and advancing research for better treatment options. For this reason, researchers are working hard to find new methods to identify pancreatic cancer sooner.
According to figures from GlobalData’s clinicaltrials database, research into mCRPC treatments has been on the rise over the past 10 years. Trials peaked at 115 in 2018 before declining to 91 last year. So far, 68 trials have been initiated in 2023.
The US Food and Drug Administration (FDA) on Wednesday announced it had approved Eli Lilly’s highly anticipated weight loss drug Zepbound, the latest entrant in a field of powerful – and lucrative – new obesity medicines.
With the necessary prioritization of various factors when designing your clinicaltrial, the patient experience can be overlooked or improperly addressed in study design. From a combined perspective, somewhere along the way, we tend to be able to land at what is the true design of clinicalresearch,” says Perez.
SUMMARY: Medicare spent nearly $600 million over a three-year period to pay for four cancer drugs with no clinical benefit an analysis published Monday by JAMA Internal Medicine found. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5
XTALKS WEBINAR: Driving Efficiency and Quality in ClinicalTrials Through AI & Innovation Live and On-Demand: Tuesday, May 27, 2025, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how AI is revolutionizing the efficiency and quality of clinicaltrials.
The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.
TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDAapproval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Date of FDAapproval : March 29, 2024 Approved for : To detect exposure to human parvovirus B19. TriClip size comparison photo. Photo courtesy of Abbott Medical.
Continued approval for the indication is dependent on verification and description of the clinical benefit of Epkinly in confirmatory trials. AbbVie research and development senior vice-president and chief scientific officer Thomas Hudson stated: “DLBCL is an aggressive cancer type that can rapidly progress and resist treatment.
The US Food and Drug Administration has approved a fast-acting nasal spray from Pfizer designed to treat migraines, the US pharmaceutical giant said Friday.
The latest approval is mainly based on positive findings from the single-arm, open-label, multicentre Phase I/II iMAGINE clinicaltrial of Imbruvica to treat moderate or severe cGVHD in paediatric and young adults aged one year to under 22 years.
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. Thus, FDA funding could be what is needed on this front, says Cudkowicz.
Clinicaltrials are an essential part of the drug development process. Worldwide, more than 2 million clinicaltrials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual ClinicalTrials?
Maze Therapeutics, a clinical-stage biopharmaceutical company, has raised $140 million in its upsized initial public offering (IPO), pricing shares at $16 each. Maze initiated the Phase I trial in 2024, with results expected in 2025. The offering, which includes 8.75 for an upfront payment of $150 million.
Clinicaltrials provide the scientific foundation for justifying the safety and efficacy of drugs, biologics, and devices—but are laborious, expensive, and risky. Only 10% of drugs entering clinicaltrials receive U.S. clinicaltrial workforce reported burnout since the 2020 COVID-19 pandemic.{4}
The dynamic landscape of TGCT research extends beyond Decipheras efforts. In October 2024, SynOx Therapeutics secured new investor capital raising its Series B total to $92 million and began dosing the first patients in its Phase III trial, underscoring the growing financial and clinical momentum in the field.
Abbott Laboratories announced on Monday that the US Food and Drug Administration (FDA) approved its Aveir™ single-chamber (VR) leadless pacemaker system. The Illinois-based company received the FDA nod for its new pacemaker to treat patients with bradycardia (slow heart rhythms).
The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinicaltrial space. Hybrid or decentralised clinicaltrials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.
GlaxoSmithKline LLC (GSK) recently announced that the US Food and Drug Administration (FDA) approved Jesduvroq (daprodustat), a new once-a-day oral treatment for anemia due to chronic kidney disease (CKD). The approval is currently only for adult patients who have been undergoing dialysis for at least four months.
Pediatric rare disease clinicaltrials are vital to determining the safety and efficacy of medications for children living with a rare disease. Therefore, pediatric rare disease clinicaltrials are vital to determining the safety and efficacy of medications for children living with a rare disease. adults).
NORD, along with its more than 330 member patient organizations, is “committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services.”. Can you tell us a bit about the work you are doing at NORD and how it impacts clinicaltrials for rare diseases?
Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinicaltrials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinicaltrial design that have historically led to trial failure?
There are four FDA-approved ADHD-specific nonstimulant drugs, namely Eli Lilly’s Strattera (atomoxetine), Shionogi’s Kapvay (clonidine), Takeda’s Intuniv (guanfacine) and now Supernus’ Qelbree (viloxazine). In 2002, Strattera became the first FDA-approved nonstimulant drug to treat ADHD in adults.
The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology. The FDAapproval sent Daiichi Sankyos shares soaring by 8.7% to 4,437 yen, reflecting investor confidence.
Daxxify was FDA-approved for similar cosmetic purposes as Botox and other neuromodulators like Dysport and Xeomin. Used for both cosmetic and therapeutic cases, Botox is a US Food and Drug Administration (FDA)-approved injection of botulinum toxin, a neurotoxic protein that can effectively paralyze the facial muscles.
XTALKS WEBINAR: Time for Change in NASH: How Non-Invasive Biomarkers are Driving a Paradigm Shift in ClinicalTrials and Clinical Care. More than 70 research publications and presented abstracts on clinical data show the potential of Terlivaz for treating HRS. Outcomes of ClinicalTrials of Terlipressin.
Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinicaltrial. Elahere is said to be the first ADC to receive FDAapproval for platinum-resistant disease. The ADC comprises an FR?-binding
This is the first approval for Biktarvy in paediatric indication in the EU and applies to all 27 EU member states, Liechtenstein, Norway and Iceland. The latest development is based on data obtained from an open-label clinicaltrial of Biktarvy.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Pfizer spinout SpringWorks Therapeutics’ Ogsiveo (nirogacestat) has received US Food and Drug Administration (FDA) approval for the treatment of desmoid tumors, an ultra-rare subtype of non-cancerous soft tissue sarcomas that can cause severe pain and disfigurement.
The findings were made via Lilly’s SURPASS phase 3 global clinical development programme, which comprised studies ranging from 40 to 52 weeks. These examined Mounjaro in 5mg, 10mg and 15 mg doses in five clinicaltrials, used either as a stand-alone therapy or as an add-on to other diabetes medicines.
The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinicaltrial portfolio.
Almost 40 years since it was instituted, some have described the FDA’s orphan drug program, which is meant to foster innovation, as “ one of the most successful US legislative actions in recent history ”. An orphan drug designation does not automatically translate into approval.
Register for this free webinar to learn new ways to operationalize hybrid oncology trials and how virtual sites help reduce patient burden. The featured speakers will discuss where the industry is headed with decentralized clinicaltrials and oncology. ClinicalTrials and Commercialization. How Does Rolvedon Work?
MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
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