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With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution (..)
By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.
On February 7, at a town hall organised to discuss clinical trial 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.
The American Journal of Bioethics ( AJOB ) this week issued a call for peer commentaries for a forthcoming special issue on pragmatic clinical trials. Both of the target articles for the special issue are from the NIH Pragmatic Trials Collaboratory’s Ethics & Regulatory Core.
Clinical trial kits, which contain necessary items for site visits like sample tubes, labels, and instructions, all conveniently customized by trial and visit, are a staple of clinical trials. On the surface, putting the kits together might seem simple enough, but it’s not.
The idea that the heart contains the very ‘essence’ of a person might be more than just a spiritual concept. Ever since the first human heart transplants back in 1967, patients have reported, often reluctantly, some eerie and inexplicable changes to their personalities.
Virus containing droplets were suspended in the CELEBS experimental device for different durations before infectivity was tested. Allen Haddrell/University of Bristol) Keeping CO2 levels low reduces infectious airborne viral loads, new research suggests.
This means that if someone drinks 50 ml of 40 percent spirits, which contains […]. It is marketed by Swedish firm Myrkl as “the pre-drinking pill that works” The pill is said to break down up to 70 percent of alcohol after 60 minutes.
The pill, called Opill – the brand name for the tablet formulation of norgestrel – is an oral contraceptive containing only progestin hormone, which helps prevent pregnancy […]
The tool kit is intended for research teams conducting pragmatic clinical trials, including those participating in the NIH Pragmatic Trials Collaboratory’s Demonstration Projects. For more information, see the Patient-Reported Outcomes chapter of the Living Textbook.
Scientists have demonstrated how nasal drops containing a particular molecule can help mice recover from the damaging biological consequences of a stroke – and the hope is that the treatment could eventually be transferred to humans. link] Crucially, the treatment isn’t applied straight away but is initiated seven days after the stroke.
By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.
The zest of oranges has now been found to contain a novel, bioactive compound, called feruloylputrescine (FP), that could benefit heart health when eaten. The bitter peel of an orange is there to protect the fruit, and it could protect our own insides, too, if only we stopped throwing the rinds away. Its discovery in […]
Phesiâs artificial intelligence (AI) driven platform, Trial Accelerator, has reached a milestone and now contains global data from more than 100 million patients.
An investigator-led trial of Jazz Pharma’s cannabis extract-based drug Sativex in glioblastoma – an aggressive form of brain cancer – will get underway in the UK next year. The post Trial of Jazz’ cannabis drug in glioblastoma will start next year appeared first on.
The drug control department in Tamil Nadu will soon introduce an action plan to contain antimicrobial resistance (AMR), and a stakeholders meeting is likely to be held very soon, It is learnt from reliable source that in the state action plan, the drug control department will have a significant role in implementing the programmes.
The role of sugars in public health continues to be urgently debated among nutrition scientists and health professionals—yet the science behind the effects of various fructose-containing sugars (e.g., sucrose/table sugar, high-fructose corn syrup, fructose/fruit sugar) on overweight and obesity has been unclear.
May 19, 2024: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. Workshop Summary & Additional Resources Agenda and Slides Welcome and Introduction Emily O'Brien, PhD Session 1: What Are Embedded PCTs (ePCTs)?
In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. Nutrient-rich foods containing omega-3 fatty acids, prebiotics and curcumin could also help improve immune function and alleviate symptoms.
The Multidisciplinary Committee (MDC) of Experts has recommended the prices of various fixed dose combinations (FDCs) containing dapagliflozin, sitagliptin, vildagliptin, pioglitazone, among others in tune with the recent amendments made by the Department of Pharmaceuticals (DoP) in the Drugs (Prices Control) Order (DPCO), 2013 related to fixing prices (..)
Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples.
AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.
The Drugs Technical Advisory Board (DTAB) has recommended to get comments and inputs from Indian Council of Medical Research (ICMR) for further action on restricting Nicotine Replacement Therapies (NRTs) containing upto 2 mg or 4 mg only through prescription of authorised medical practitioners, as proposed by the Tobacco Control Division (TCD).
CyclASol is topical anti-inflammatory and immunomodulating ophthalmic drug solution containing 0.1% Findings from the long-term extension ESSENCE-2 OLE trial showed that CyclASol’s effect was maintained and improved for most endpoints over a treatment period of 52 weeks.
Clinical trials of a wireless brain chip developed by Elon Muck’s Neuralink company will be tested in human volunteers within the next six months – and Musk himself says he intends to have one implanted for a future demo event. The post Elon Musk’s Neuralink brain interface chip set for human trials appeared first on. link] (12/12).
Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking. Still study trials show Wegovy is more effective than any other weight loss management drug currently on the market.
Psychiatric disorders in particular represent a trial area with significantly high drop-out rates and poor patient recruitment. Despite this, new strategies devised over the last five years are beginning to reverse the trend, and both reduce stigma and increase awareness to funnel new patients into these important trials. .
For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.
A medical device sponsor is conducting a clinical trial on an innovative cardiac stent. The sponsor has chosen to take a hybrid approach to their study to decrease risk and increase patient safety, adhering to the FDA’s guidance on conducting clinical trials during the pandemic. It’s winter 2020 and COVID-19 is in full swing.
The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group. The latest MHRA decision is based on findings from the Phase II/III clinical trial, where the mRNA-1273.214 vaccine met all primary endpoints.
Xtalks interviewed Devon Adams to learn more about his work related to decentralized oncology trials as a senior analyst for legislative policy specific to clinical trials at the ACS CAN. Read on to learn more! Over 1,100 cancer patients and cancer survivors responded.
Pfizer and Moderna have provided data from their large-scale Phase 3 trials only via news releases , which contained the highly promising news that both vaccines were 90 percent effective or more and have not presented any serious safety concerns. The results of trials were announced in press releases rather than peer-reviewed papers.
Regardless of the formulation, the entire dose must be administered to each subject, and the dosing containers must be checked for residual radioactivity. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.
Clinical trials are crucial for advancing medical research and developing innovative treatments. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Data Complexity: Clinical trial data often comes in diverse formats, such as text, images, audio, and video.
Clinical trials are complex and resource-intensive endeavors, and as such, there is an increasing need to streamline clinical trial operations and increase operational efficiency. A unified platform that integrates multiple clinical trial management systems can be a game-changer in improving operational efficiency in clinical trials.
It has also been approved by the FDA for otitis media prevention in infants and children aged between six weeks and five years caused by the original seven serotypes contained in PREVNAR. The latest approval is based on data obtained from the Phase II and Phase III trials of PREVNAR 20 for paediatric indication.
Successful TIL therapy depends on the infusion product containing tumour-reactive T cells that, on infusion, generate an anti-tumour immune response that causes disease regression. Numerous academic and pharma-led studies have investigated the efficacy of TILs in the melanoma setting, with response rates ranging from very low to 50%.
An investigational late-stage product candidate, CART-ddBCMA is being analysed in the Phase II iMMagine-1 clinical trial at present. It leverages the new D-Domain binder of Arcellx and contains autologous T cells genetically modified for targeting multiple myeloma. Additionally, Kite will make other potential payments to Arcellx.
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