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patient safety
This page shows the latest patient safety news and features for those working in and with pharma, biotech and healthcare.
bluebird bio temporarily suspends trials of sickle cell gene therapy LentiGlobin
Another SUSAR of myelodysplastic syndrome (MDS) in a patient from group C of HGB-206 was also reported last week, which bluebird also said it is currently investigating. ... The safety of every patient who has participated in our studies or is treated
Latest news
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Shionogi’s novel antibiotic trial data published in The Lancet
journal. The data comes from the APEKS-NP and CREDIBLE-CR studies, which both demonstrated the efficacy and safety of Fetcroja against certain difficult-to-treat Gram-negative bacterial infections. ... The results of the CREDIBLE-CR study provided
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Delivering safe and effective clinical trials during the COVID-19 pandemic
for staff, their families and patient volunteers, providing results in approximately 20 minutes. ... There will be greater scrutiny on staff and patient safety and public health measures to protect our communities; this has been seen in recent surveys of
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Biogen plans Spinraza study in SMA patients treated with Novartis’ Zolgensma
The trial will evaluate the efficacy and safety of Spinraza in this patient setting by assessing changes in motor function measures as well as additional clinical outcomes, including swallowing and caregiver ... Novartis’ gene therapy was approved to
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Lilly halts most clinical trials as coronavirus disruption continues
analysis. “In the interest of helping to ensure patient safety and minimising further stress on the system, Lilly has decided to take several proactive steps in regard to our clinical trial
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Novartis says data backs safety of on-hold intrathecal Zolgensma
Preliminary safety and efficacy data from the trial were reported earlier in the same month. ... Novartis now says new results from STRONG are in, with no new safety signals or patient deaths, and 'remarkable' efficacy in older children with SMA type 2
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Latest Intelligence
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A cultural shift in clinical research
highest levels of patient safety. ... Similarly, telemedicine is now frequently used for routine patient monitoring and follow-ups, particularly in phase 1 studies.
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AI and accelerated computing ring in new era for healthcare
As an added bonus, researchers can collaborate on AI model creation without sharing confidential patient information. ... These application frameworks facilitate a critically needed ecosystem of AI solutions for hospital public safety and patient
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Rare genetic diseases – what’s in store for 2021?
The healthcare industry will need to react and adapt to changes in safety and regulatory processes, patient access to medicines, access to research, clinical trial recruitment and the supply of medicines ... We’re looking at digital advances that would
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Well-funded life sciences firms are making long-term progress – and their investors are too
This in turn means greater patient safety as well as an overall improved patient outcome.
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Keeping up with the developing regulatory requirements for gene and cell therapies
Other safety and manufacturing events such as three patient deaths in the high-dose arm of the Audentes’ ASPIRO trial and an FDA refusal to review the biologics licence application for ... must create manufacturing processes for cell and gene therapies
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Latest appointments
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Dr Ameet Nathwani moves from Novartis to Sanofi
As chief medical officer Dr Nathwani will be responsible for the pharmaceutical firm's medical, patient safety and medical quality assurance as well as the transparency and compliance standards of
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NDA Group appoints Bill Griffiths as general manager, UK
Based in Leatherhead, Surrey, Griffiths will be responsible for managing the European regulatory affairs and patient safety consultancy's business in the UK with effect from 1 March.
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AstraZeneca appoints Sean Bohen as chief medical officer
As CMO he will ensure patient safety across AZ's entire portfolio and additionally be responsible for pushing medicines from late-stage development through to regulatory approval.
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NHS England names director for new models of care
layers” of processes and improve patient safety and experience.
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Amgen appoints ex US surgeon general
Amgen has named former US surgeon general Steven Galson as senior VP, global regulatory affairs and safety. ... This direct experience in regulatory affairs and public health will benefit Amgen as Galson takes over responsibility for the company's
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Approximately 0 fully matching, plus 9 partially matching documents found.
Latest from PMHub
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How does the government plan to reshape the NHS?
where there is a clear patient safety or other important clinical interest. ... value propositions help the NHS to improve patient outcomes and also deliver on wider priorities.
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Waterland-backed imc group progresses ambitious growth strategy with the addition of Indigo Medical
divisions: Medical &Scientific Content, Publications, Digital &Creative, Insights &Consulting, Patient Engagement, Meetings &Events, and Medical Compliance &Material Review. ... industry leading compliance and medical expertise which is ultimately about
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Achieve clinical trial diversity by introducing cultural safety
Cultural safety training also encompasses improving cultural awareness and understanding. It’s been found that practitioners’ increased cultural competence has been linked to increased patient satisfaction, treatment adherence and information
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Real-world evidence: breaking boundaries in rare disease
Generating data for drug launches is a challenging process. In rare diseases, with small patient populations and high unmet need, evidence generation is even more complex. ... Traditional randomized clinical trials (RCTs) are considered the gold-standard
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How has the pandemic reshaped the NHS in 2020?
Digital services. Covid-19 has expedited digital patient engagement, which was a fundamental aspect of the Long Term Plan. ... Patient safety, with regard to how a particular drug fits into the new Covid-friendly pathways, continues to be a critical
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Approximately 2 fully matching, plus 21 partially matching documents found.
COVID-19 Updates and Daily News
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- AZ showcases data for next-generation PARP inhibitor AZD5305
- GSK discontinues two feladilimab trials in head and neck cancer
- Novavax seeks FDA emergency approval for COVID-19 vaccine by May
- Pfizer/BioNTech say their COVID-19 vaccine can be stored at warmer temperatures
- Sanofi pays $160m upfront to acquire Tidal Therapeutics
- Moderna’s booster vaccine for South African variant demonstrates promising early results
- Live Webinar: Advancing Human Health Through Precise Measures of Movement, Cognition & Biometrics
- Live Webinar: How to Simplify Genetics & Raise Awareness Around Orphan Diseases
- Lilly asks to revoke emergency authorisation for bamlanivimab monotherapy in the US
- CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval
- Alexion and NICE agree confidential discount for Ultomiris use on the NHS
- Novartis’ MS therapy Kesimpta reduces risk of disability progression regardless of relapses
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