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Safety trial
This page shows the latest Safety trial news and features for those working in and with pharma, biotech and healthcare.
COVID-19: Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP
The positive opinion was based on results from a phase 1 pharmacokinetic study, Gilead said, as well as results from the phase 3 REDPINE trial that evaluated the safety of Veklury
Latest news
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FDA issues new draft guidance on decentralised clinical trials
The document includes recommendations on trial design and the use of digital health technologies. ... Guidance on determining the appropriateness of investigational products for use in a DCT, packaging and shipping of investigational products, and safety
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Biogen and Eisai’s Alzheimer’s drug associated with positive long-term health outcomes
The analysis is based on a disease simulation model that used data from the phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, as well as ... The drug has since been granted priority review for traditional approval
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Merck and Ridgeback’s COVID-19 pill fails to prevent infection within households
The phase 3 MOVe-AHEAD trial evaluated the safety and efficacy of Lagevrio compared to placebo in preventing the spread of SARS-CoV-2 within households. ... Li added that, because MOVe-AHEAD was not a treatment trial, these latest results will not impact
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Oramed’s oral insulin candidate fails to meet phase 3 targets
We thank all the patients, families and healthcare professionals who participated in the trial.”. ... The announcement comes just months after the company reported positive results from its phase 2 trial assessing the safety and efficacy of ORMD-0801
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Novavax initiates phase 2 combination COVID-19/flu vaccine study
Initial results from the trial are expected towards the middle of the year. ... The randomised, observer-blind trial will evaluate the safety and effectiveness of different formulations of the company’s recombinant protein-based COVID-19 vaccine,
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Unlocking the potential of data sharing
For example, personal data cannot be deleted if it is related to clinical trial subjects. ... assessments. With the advent of increasingly sophisticated ways to process the data, scientists can now utilise platforms that share information instantly,
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Addressing the diversity issue in clinical trials
Diversity matters. With any clinical trial, safety is paramount. A biased or inadequate assessment of adverse reactions jeopardises regulatory approval. ... The safety and efficacy of any treatment varies depending on a range of factors.
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Building a brighter future with patient support programmes
They are the multipurpose building blocks that improve patient safety, pharmacovigilance, trial enrolment and retention, disease management, adherence, market share and quality of life for patients.
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Pre-launch planning and DSLs – the new ways to create launch excellence in pharma
Further topics that they might discuss regarding your drug candidate could be the study and drug trial data, safety and effectiveness, customer experience or general education and information. ... But for launch, you are likely to want to understand the
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The lessons learned from COVID-19’s impact on oncology trials
Going to a medical facility to participate in a clinical trial, even with safety protections and protocols in place, can be too dangerous for many with cancer to even consider. ... These facilities, in many cases, also double as investigator sites for
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Achieve clinical trial diversity by introducing cultural safety
Yes, your clinical trial population might be far from diverse and inclusive at the moment. ... Get in touch to find out about our cultural safety training here at COUCH Health.
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Mistrust in medical research: a patient perspective
They are asking: what are the ingredients? How many people participated in a trial? ... In the meeting, they provided a transparent view of the drug development process, including why it usually takes so long to conduct a trial, how is long-term safety
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October 2020: diversity and inclusion in clinical trials round-up
Concerns are increasing about the low rates of trial participation in important subgroups, including Black communities. ... Trial sponsors and regulatory agencies can ensure that the informed consent process is exemplary.
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Patients are ready to embrace decentralised clinical trials, are you?
Traditional clinical trial designs simply can’t withstand the impact of COVID-19. ... In March, they put out recommendations such as phone contact, virtual visits and “additional safety monitoring for those trial participants who may no longer have
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The Biosimilar Challenge
The Physicians’ Perspective. Originally many prescribers were reluctant to try biosimilars due to questions around the robustness of clinical trial data and long-term safety.
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- Novartis receives EC approval for Cosentyx in hidradenitis suppurativa
- BMS and Janssen’s antithrombotic granted FDA fast track designation
- Sanofi's frexalimab shows promise in relapsing forms of MS
- Amgen reports positive results for Otezla in psoriatic arthritis
- EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug
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- Novartis receives EC approval for Cosentyx in hidradenitis suppurativa
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