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The Central Drugs Standard Control Organisation (CDSCO) has requested all stakeholders in the medical devices sector to deposit the requisite fee for retention of license or registration certificate under the Medical Devices Rules (MDR), 2017, well before the stipulated timeline in order to avoid cancellation of the approvals.The drug regulator, in (..)
The Central Drugs Standard Control Organisation (CDSCO) and Indian Council of Medical Research (ICMR) have together released the draft standard evaluation protocols for the purpose of issuing license for in-vitro diagnostics (IVDs) under the Medical Devices Rules (MDR), 2017.
The national drug regulator has withdrawn the powers delegated to the State and Union Territory (UT) Licensing Authorities to issue No Objection Certificates (NOCs) for manufacture of unapproved, banned or new drugs solely for export purpose, asking the industry to file fresh applications with the central authority online from May 15.
C4X Discovery (C4XD) and AstraZeneca have entered an exclusive global licensing agreement worth up to $402m to develop oral therapy to treat inflammatory and respiratory ailments. According to the deal, C4XD is entitled to get up to $16m in pre-clinical milestone payments before the commencement of the first clinicaltrial. .
The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the […]
The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime.
With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area. Vice President of Scientific Solutions, Neuroscience, at Worldwide ClinicalTrials. These trials are often someone’s last hope,” Moore said. billion in 2027.
The Union ministry of health and family welfare has said that most of the e-pharmacies in the country have informed the Central Drugs Standard Control Organisation (CDSCO) that they are only providing an online platform connecting the users and the licensed pharmacies, in response to the show-cause notice from the drug regulator sent early this […] (..)
With the chemists and druggists across the country opposing the sale of drugs through online, the Central government is taking a stand that the sale of medicines should be strictly under the provisions of the existing regulations and the State Licensing Authorities (SLAs) are legally empowered to act against violation of the legal provisions.
The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June. […]
The adoption of decentralized clinicaltrial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Rachel Colite, VP Decentralized ClinicalTrials, Cogstate.
Have you been tasked to develop a clinicaltrial budget? Well, you’re in luck because I’m going to share everything you need to know about clinicaltrial costs. Clinicaltrial budgets are often put together in haste. Developing a clinicaltrial budget can be a confusing exercise for sponsors and CROs.
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinicaltrials.
Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.
The landscape of clinicaltrial management is undergoing a significant transformation, driven by the complex demands of modern medical research. As we delve into the challenges posed by point systems, it becomes clear that a platform approach is not just beneficial but essential for the future of clinicaltrials.
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinicaltrials. The poll of 114 triallists by clinical data specialist ERT found 82% of them found organisations aery using “virtual trial” approaches.
According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinicaltrials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.
Currently, the standard treatment for CAH involves glucocorticoids, which replace cortisol and help regulate hormone levels. In the first trial, 122 adults received Crenessity twice daily and 60 received placebo twice daily for 24 weeks. billion in revenue by 2024.
Dears Please find hereinafter the latest news related to ClinicalTrials in the EU with a respective indirect tax and pharma regulatory licensing impact: 1. The CTIS database is publicly available and leads to increased transparency for indirect tax & pharma regulatory licensing. •
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
Avoiding “Customs Chaos” in ClinicalTrials Means Working Closely with Your Importer of Record Many global clinicaltrial shipments get muddled regarding the critical role and responsibilities of the importer of record (IOR) for clinicaltrials.
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. If a single-arm trial was conducted as the pivotal trial for regulatory approval of those existing products, the sponsor will certainly want to do the same. Simply, BIAS.
Akili already has the first and only FDA cleared video game-based digital therapeutic (DTx) for children with attention-deficit hyperactivity disorder (ADHD), but is looking to add to its range via a licensing deal with Australia’s TALi Digital. . It takes around 20 minutes of game play to provide a reading.
Implementing Electronic Data Capture (EDC) systems in clinicaltrials offers numerous benefits, including improved data accuracy, faster data availability, and streamlined processes. Implement comprehensive data governance policies, and regularly train staff on data security and privacy regulations.
The findings showed that the Nuvaxovid booster dose increased immune responses compared to higher levels associated with the protection in Phase III clinicaltrials. Nuvaxovid demonstrated a significant antibody response when given as a booster dose after primary vaccination with other authorised Covid-19 doses in the COV-BOOST trial.
LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population.
billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The post AbbVie preps filings for lymphoma bispecific licensed from Genmab appeared first on.
Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.
Like with small molecules, clinicaltrials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics.
Technological advances, changing patient preferences and evolving guidance from regulators and policy makers have all supported new research methods that break down barriers to participation. Pharmaceutical, life sciences and healthcare organizations have long had the desire to make their research programs more accessible and patient-centric.
It is also licensed by Spain’s Centro de Investigación Biomédica en Red de Enfermedades Raras, the Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz and the Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas. The therapy has also received orphan drug and fast-track designations.
She decided to focus on patient recruitment to promote diversity in clinicaltrial populations. Today, she’s Head of GP Engagement and Patient Recruitment for Velocity Clinical Research in the U.K. Through it all, her commitment to and belief in clinical research never wavered. Amira said, “ I have been in the U.K.
Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca. Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinicaltrial.
Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. If an mHealth device is life sustaining, then the FDA is certainly going to regulate the device.
A common set of standards for randomised clinicaltrials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. Many guidelines focus narrowly on clinicaltrials that are intended to generate data for regulatory submission to support a new drug license.
In doing so, it helps regulate calcium and phosphate more naturally, potentially limiting urinary calcium excretion and supporting kidney and bone health. Eneboparatide is engineered to bind with high affinity to a specific conformation of the PTH1R, essentially mimicking the hormones natural action.
Bureaucracy, political upheaval, and lack of regulations continue to make Latin America a difficult market for European and North American pharma to enter – and COVID-19 has only worsened these issues. For example, price regulations are becoming more common in Latin America, often being based on models such as NICE’s.
The UK drugs regulator is now asking that all applications for new medicines or indications detail the efforts made to involve patients in the drug development process. . In future, the hope is that it may encourage a higher level of patient involvement in its final assessment of whether clinicaltrials are approved or drugs are licensed.
Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. It is developed based on MyoKardia's drug discovery platform. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.
NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. Small molecule candidate Anle138b targets disease modification for multiple system atrophy and other neurological disorders.
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