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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.

Solid Bio falls as FDA halts DMD trial over safety concerns

The FDA has halted the IGNITE DMD trial because of safety concerns, after a patient experienced a serious adverse event (SAE) which was deemed related to the drug. ... It reported the event to the FDA and the study's Data Safety Monitoring Board (DSMB).

Latest news

The business case for patient engagement

But does it pay off beyond the important, but intangible, benefits of patient safety? ... This double dividend is key when trying to quantify the value of patient engagement.
Hancock trumpets £250m fund for AI in the health service

The investment has been cautiously welcomed by health experts, although the independent Health Foundation charity warned that “technology needs to be driven by patient need and not just for technology's ... He went on: “Rolling out new technologies
Report shows benefits of GP at Hand digital service, but concerns too

Some doctors mentioned downsides, such as a disconnection from the patient population, and some technical issues with video-conferencing. ... The lack of any serious clinical or patient safety concerns, and the many positive signs, suggests Babylon will
Europe responding to gene therapy challenge, but picture remains fragmented

Among its provisions are plans for compulsory patient registries for all orphan products and medicines approved via conditional approval or exceptional circumstances. ... patient registry to monitor safety, but a second national-level registry was also
Akcea gets first OK for Waylivra in rare triglyceride disorder

The FDA had voiced concerns about the drug’s safety, particularly some reductions in blood platelet counts (thrombocytopenia) among patients treated with the antisense agent. ... In Europe, Akcea has committed to a non-interventional post-authorisation

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Latest Intelligence

Encouraging signs in biomarker R&D

In other words, a patient’s TMB level was no help when it came to predicting whether the combined regimen would work. ... Patient safety drive. For John Haanen, demands for safer immunotherapies are also a factor in the FDA’s call for biomarker and
Streamlining clinical trials – why better data use is key

Compliance requirements are in place to ensure patient safety when a drug ultimately comes to market. ... endpoints and patient safety, which can lead to better data, faster enrolment and reduced patient burdens.”.
Immunotherapy combination trials Q&A

In particular, what approaches should be taken in regards to patient recruitment for these trials? ... Regulatory oversight of interventional studies has been tasked with ensuring patient safety, while also helping to encourage cost containment through
AstraZeneca’s oncology renaissance

So how did AstraZeneca achieve this turnaround? In 2010 Mene Pangalos introduced a ‘5R framework’ for R&D: right target, right patient, right tissue, right safety, right commercial potential.
In conversation with Pfizer’s Erik Nordkamp

Both in terms of productivity gains, healthcare outcomes, and patient and healthcare professional experience. ... This is an educational approach for junior doctors and is designed to increase patient safety and reduce human error by improving

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Latest appointments

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
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.
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.
NHS England names director for new models of care

layers” of processes and improve patient safety and experience.
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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Latest from PMHub

Spotlight on innovation at life sciences forum

AHSNs drive patient safety and reduce avoidable harm. ... How innovative digital technology has been implemented through AHSNs to improve patient outcomes.
The story behind Chloe Mitchell

What attracted you to the Medical Communications industry? In my previous role in Patient Safety, my knowledge was product specific and I felt that Medical Communications would give me a broader ... My previous role in patient safety required 6–9
HSJ Partnership Awards 2019 shortlist announced

The Value Awards recognises achievements in improved efficiency that also benefit the patient. ... Patient Safety Awards. Recognising the hardworking staff of the NHS the Patient Safety Awards represents innovative projects, dedicated people and
Healthcare excellence celebrated at 2018 HSJ Awards

The Value Awards recognises achievements in improved efficiency that also benefit the patient. ... Patient Safety Awards. Recognising the hardworking staff of the NHS the Patient Safety Awards represents innovative projects, dedicated people and
HSJ Awards Finalists Announced

The Value Awards recognises achievements in improved efficiency that also benefit the patient. . ... Patient Safety Awards Recognising the hardworking staff of the NHS the Patient Safety Awards represents innovative projects, dedicated people and