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Bringing a psychedelic into a clinicaltrial setting is complex and requires a thorough operational approach to ensure the study’s success. Psychedelic trials need to be done with scientific rigor. Our team published recently in The Journal of Psychedelic Psychiatry exploring how we can bring more rigor to these trials.
The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.
In order to better streamline the approval process for manufacturing license to the medical devices units, the Central government is looking at amending the relevant rules in the Medical Device Rules (MDR), 2017 to include various timelines related to grant of manufacturing license to the four classes of medical devices in the country.
Vice President of Scientific Solutions, Neuroscience, at Worldwide ClinicalTrials. Of note, these programs differ significantly from conventional psychiatry trials. In a nonpsychedelic trial, sites should remain neutral with patients to remove non-specific treatment effects. Managing the ethics of psychedelic trials.
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.
The Phase I trial showed promising safety and pharmacokinetics. Maze plans to begin a Phase II trial in 2025 and expects proof-of-concept data by early 2026. Maze initiated the Phase I trial in 2024, with results expected in 2025. Notably, MZE001, a program for Pompe disease, was licensed to Shionogi & Co.
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 Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.
The Central government’s actions to mandate licensing of all medical devices is posing a challenge to the industry, especially the micro and small enterprises in the sector, says the Surgical Manufacturers and Traders Association (SMTA), the pan India organisation of manufacturers and traders of surgical equipment for healthcare services providers (..)
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.
Empowering of the Central Drugs Standard Control Organisation (CDSCO) through centralisation of drug licensing may not be the path to improve the quality of drugs manufactured in the country both for domestic and international markets, says SME Pharma Industries Confederation (SPIC), the apex organisation of small and medium pharma industries in the (..)
This is relevant for clinicaltrials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.
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.
Clinicaltrials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. Understanding the factors driving clinicaltrial costs is essential for researchers, sponsors, and other stakeholders involved in the drug development process.
Monitoring patient safety during a clinicaltrial is one of the founding principles to be followed throughout the drug development life cycle. It can be defined as a collaborative relationship between sponsors, sites, researchers, and everyone involved in the clinicaltrial phases.
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.
Sling Therapeutics has positive topline results from its Phase IIb/III LIDS clinicaltrial evaluating its oral small-molecule therapy linsitinib for the treatment of thyroid eye disease (TED). Ninety patients in the trial were randomized to receive one of two doses of linsitinib or placebo.
The Phase IIb clinicaltrial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). A disease simulation model was created based on the results of the clinicaltrial and published literature to understand the long-term benefits of lecanemab use.
Leqembi is indicated to treat mild cognitive impairment or mild dementia stage of the disease in patients whose treatment started in clinicaltrials. The regulatory approval is based on the data obtained from the Phase II trial. Leqembi met the primary endpoint and all the critical secondary endpoints in the Clarity AD trial.
According to the deal, Cidara will continue to oversee the international Phase III ReSPECT prophylaxis clinicaltrial underway. The post Melinta and Cidara sign licensing deal for rezafungin appeared first on Pharmaceutical Technology. At the time points mentioned in the deal, the NDA will be transferred to Melinta. “We
The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinicaltrial. Furthermore, Enhertu’s safety profile was in line with prior clinicaltrials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4
In the Phase III portion of a Phase II/III clinicaltrial in Asia, ensitrelvir met the primary endpoint. The post Shionogi and MPP enter Covid-19 antiviral licensing deal appeared first on Pharmaceutical Technology.
In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinicaltrials.
Biogen has exercised an option to license Denali Therapeutics ’ (Denali) programme to develop immunotherapies for the treatment of Alzheimer’s disease. We are pleased with Biogen’s decision to license ATV: Aβ and we are hopeful this will foster the development of next-generation anti-Aβ therapeutics.”
The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies of In-vitro Diagnostic Medical Device (IVDMD) to aid manufacturers in the preparation of premarket review documents for the import or manufacturing license applications.
Currently, there are no licensed vaccines against these viruses. The organisation has commenced Phase II clinicaltrial planning in Uganda and Kenya. Sabin’s Ebola Sudan vaccine was found to be immunogenic and safe based on previous clinicaltrials.
The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.
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.
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. .
Bio-Thera Solutions and Biomm have entered a licensing and supply agreement for Bio-Thera’s BAT2206, a ustekinumab biosimilar. The therapy, which completed a Phase I trial, is now being assessed in an international Phase III clinicaltrial that includes participants from China and Eastern European countries.
German biotechnology firm 3B Pharmaceuticals (3BP) has entered into a licensing agreement with Novartis Innovative Therapies for its fibroblast activation protein (FAP)-targeting peptide technology. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinicaltrial.
It was discovered by Incyte and licensed to Novartis in 2009. The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinicaltrial of Tabrecta in patients with advanced NSCLC harbouring alterations leading to METex14 skipping. A kinase inhibitor, Tabrecta acts on MET.
The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.
Proceeds from the IPO will propel key initiatives, including the Phase II clinicaltrial of Jotrol in Parkinson’s disease. These efforts aim to fast-track commercialization and out-licensing agreements in one of the world’s most promising pharmaceutical markets.
Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.
The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinicaltrial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.
The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinicaltrial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in mHSPC patients.
In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca. According to data from the PROVENT clinicaltrial, AZD7442 demonstrated a statistically significant decline in symptomatic Covid-19 development risk.
While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinicaltrials towards the end of 2022.
Under the Mission COVID Suraksha Program, DBT, the Indian Government and BIRAC provided funding for the development and clinicaltrials of the vaccine. Phase III trials of BBV154 were conducted to evaluate its safety and immunogenicity in approximately 3100 participants in 14 trial sites across the country.
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