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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.
The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientificâs Nantheia ATL5, a candidate for treating opioid use disorder.
The latest approval is based on findings from the Phase III clinicaltrials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?
The findings were made via Lilly’s SURPASS phase 3 global clinicaldevelopment 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.
On February 7, at a town hall organised to discuss clinicaltrial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.
Zavegepant has an advantage over the two as it’s the only CGRP receptor antagonist in both intranasal spray and oral pill formulations that is in clinicaldevelopment for the treatment of acute or episodic migraines. The trial has enrolled over 1,400 adult participants with a history of migraines.
Roche is hoping to undercut hugely expensive rivals after the FDAapproved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). The FDAapproved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinicaltrials, as seen below ( italics to note updated language). The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinicaltrials.
cyclosporine A) is currently at pre-registration stage with the FDA, following results from late-stage clinicaltrials that demonstrated CyclASol significantly reduced corneal and conjunctival staining, and improved ocular dryness compared with vehicle. Novaliq’s CyclASol (0.1%
One study found that only 5% of Black or Asian United Kingdom residents had ever participated in a clinicaltrial. A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Clinicaltrial diversity improved during COVID-19 (but not enough) .
The latest result has undermined the company’s hopes that PH94B would become the first FDA-approved, on-demand treatment for patients who suffer from SAD, but it’s not the first setback for the company. VistaGene meanwhile is also developing PH10, another pherine nasal spray heading for a phase 2b study in MDD.
COMP360 is a crystalline formulation of psilocybin in phase 2b clinicaldevelopment in patients who have not responded to standard therapy for depression. MindMed has a combination of the MDMA and LSD in a phase 1 clinicaltrial scheduled to start this year, to see if the drugs can be used to aid a psychedelic-assisted therapy session.
Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinicaltrials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on. sensitivity and 93.3%
In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinicaldevelopment in patients who have not responded to standard therapy for depression.
Otsuka Pharmaceutical has announced positive interim results from its Phase III clinicaltrial for sibeprenlimab. Based on the promising interim data, Otsuka plans to submit the results to the US Food and Drug Administration (FDA) for potential accelerated approval.
While the pandemic dramatically increased public awareness of mRNA therapeutics, lesser-known categories of RNA-based therapies have been established and approved for use by the FDA for almost a decade. RNA-based drug development warrants close monitoring as more RNA drug assets enter late-stage clinicaltrials.
In alignment with Novavax’ commitment to transparency, Phase 3 clinicaltrial protocols are posted to the company’s website at Novavax.com/resources upon finalization. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinicaltrial being conducted in the U.K.
With so many novel drug candidates for Alzheimer’s disease failing in clinicaldevelopment, researchers in the US have started using artificial intelligence (AI) to screen already-approved therapies for activity against the neurodegenerative disorder. .
The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinicaltrial and part of 55 globally, across 15 countries. The trial is expected to enrol 99 ambulatory male patients, aged four to seven.
Mobasher Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinicaltrials. Zanubrutinib has five US Food and Drug Administration (FDA)-approved indications and the broadest label in its class.
Proceeds from the IPO will fund preclinical and clinicaldevelopment for Polyrizon’s innovative hydrogel product candidates, supporting further research and development (R&D). The IPO, priced at $4.38 Trading began on the Nasdaq Capital Market under the ticker “PLRZ” on October 29, 2024.
Having already brought their mRNA-based CVID-19 vaccine Comirnaty to market at breakneck speed, Pfizer and BioNTech are hoping to fast-track a vaccine for shingles based on the same technology platform through clinicaldevelopment, with trials due to start later this year.
OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.
and 2 trials planned by our sublicensee WPD in Poland. and 2 trials planned by our sublicensee WPD in Poland.
Reddy says one of LabCorp’s groundbreaking tests, OmniSeq INSIGHT, is an “all-in-one test that includes comprehensive genomics and immune profiling from a single tissue sample to identify all FDA-approved therapeutics, confirm immunotherapy eligibility for a patient, and identify appropriate nearby clinicaltrials.”.
FDAApproves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Amivantamab is under clinicaldevelopment by Johnson & Johnson and currently in Phase I for Colorectal Cancer. GlobalData’s report assesses how Amivantamab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
COMP360 is a crystalline formulation of psilocybin in phase 2b clinicaldevelopment in patients who have not responded to standard therapy for depression. Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO shortly after the announcement.
Scott Freeman said in a statement , “our ability to start this trial on schedule speaks volumes to both the efficiency and high caliber clinicaldevelopment team Mind Medicine has assembled to develop medicines based on psychedelics.
This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). percent and the risk of developing severe RSV-associated LRTD by 94.1
Pfizer’s PAXLOVID™ receives FDAapproval for adult patients at high risk of progression to severe COVID-19 Pfizer Inc. NYSE: PFE) announced today that the U.S. ” COVID-19 continues to cause significant burden in the U.S. Source link: [link]
The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinicaltrials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinicaltrials for the treatment of COVID-19.
Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDAapproved 131 FDC products, on average 5.7 Dosing is not left up to physicians; it is built into the FDC product and based on clinicaltrial results. More FDC products flowing into pharma pipelines.
The clinicaltrials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. Additionally, the clinicaltrials underscored the favorable tolerability profile of Vevye.
Leqselvi’s approval is based on data from two Phase III clinicaltrials, THRIVE-AA1 and THRIVE-AA2, which together enrolled over 1,200 patients. Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.
QUEST is a 180-subject, randomized, double-blinded, active sham-controlled clinicaltrial that is being conducted under an investigational device exemption (IDE). for the clinicaldevelopment and commercialization of infectious disease molecular diagnostic products. On July 01, 2021, Seegene Inc., Roxana Mehran, M.D.,
Last year, the Royal Buckinghamshire Hospital (RBH) in Aylesbury became the first UK hospital trust to deploy a MindPod platform, which has been shown in clinicaltrials to double the effectiveness of conventional rehabilitation therapy for the upper limbs during the sub-acute phase after a stroke.
It will be six years since the US FDAapproval of Kymriah in August this year. Bruce Levine [BL]: We now have six approved CAR-T therapies. And my estimate is that between 25,000 and 30,000 patients have been treated with those therapies globally, which does not include patients treated in clinicaltrials.
Biogen and Eisai have defied the naysayers and secured an historic FDAapproval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. Breaking news: The FDA has approved Aducanumab, the first FDA-approved drug that delays decline due to Alzheimer’s.
.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinicaltrials, compassionate use or real-world settings.
Phase III BRIDGE open-label, switch-over clinicaltrial met key objectives for safety and efficacy.
galactosidase-A product candidate under development for the treatment of Fabry disease. .
CARMIEL, Israel and BOSTON , Dec. 30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc.
Despite this, the first-ever FDA-approved KRAS G12C inhibitor has demonstrated that RAS is in fact druggable and that drugging this protein unlocks a world of successful therapeutic interventions. For decades, RAS has existed as an elusive therapeutic target, and drugging this high-value oncogene was deemed impossible.
Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019, who have recently initiated a Phase 1 study with their formulation.
of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54
WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDAapproval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.
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