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product safety
This page shows the latest product safety news and features for those working in and with pharma, biotech and healthcare.
FDA rejects ViiV’s long-acting monthly HIV injection
In the CRL, the FDA cited concerns regarding the treatment’s chemistry manufacturing and controls process, but there was no issues surrounding the safety of the product.
Latest news
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Trump administration advances drug importation plan
The proposal could prove difficult for other reasons, as it also requires importers to have knowledge of regulatory processes – including safety tests and being able to manage product recalls. ... The safety tests would need to be able to demonstrate
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Roche to present new data on Spinraza rival
Roche is expected to present updated safety data for the survival motor neuron 2 (SMN2) splicing modifier at the AAN congress, along with one-year data from the dose-finding Part ... Risdiplam’s safety data could see Roche continue to build its case
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Advaxis shaken by another FDA hold on cervical cancer vaccine
The FDA hasn't cited any safety issues on this occasion, and enrolled patients will continue to receive treatment, but no new patients can enroll in AIM2CERV until the partial hold ... concluded, “Our Axal product has demonstrated a manageable safety
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Biogen and AbbVie pull MS drug Zinbryta from the market
Escalating concerns about the safety of Zinbryta (daclizumab) - and particularly cases of liver damage and immune-related conditions - are behind the decision, which was announced on the same day that the ... Last November the EMA reported that it had
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Sanofi confirms suspected safety issue with dengue vaccine
Prospects for Sanofi’s dengue fever vaccine Dengvaxia look increasingly dim after it confirmed a long-debated safety issue with the product.
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Approximately 1 fully matching, plus 80 partially matching documents found.
Latest Intelligence
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Alnylam’s big moment: bringing groundbreaking RNAi drugs to Europe
While Onpattro has outshone Ionis’ product in safety and efficacy, analysts see Onpattro’s lack of cardiovascular claims in its US label as a weak point. ... and sustainable clinical pipeline and a robust product engine by the end of 2020; a company
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Biologic or biosimilar: what are prescribers thinking?
Provenance and product availability matter: Even with proven safety and efficacy, the origins of some biosimilars raise questions. ... Many companies (eg, from Asia) are unknown, and uncertainties around delivery capabilities and safety legislation
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AI’s potential in the pharma life cycle
patient safety monitoring, artificial intelligence (AI) has substantial potential to change the way life sciences organisations operate. ... AI could also support a range of applications in product safety - for example, the use of algorithms to predict
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Managed Access Programmes: a powerful source of real-world insight
These programmes therefore offer a unique opportunity to collect real-world data before launch, providing evidence to support the product's effectiveness, safety and value. ... Even simple points such as duration of treatment, reason for discontinuation,
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Managed Access Programmes: a powerful source of real-world insight
These programmes therefore offer a unique opportunity to collect real-world data before launch, providing evidence to support the product's effectiveness, safety and value. ... Even simple points such as duration of treatment, reason for discontinuation,
More from intelligence
Approximately 0 fully matching, plus 9 partially matching documents found.
Latest appointments
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Celerion appoints chief medical officer
Previously, Dr Hoffman served as vice president of medical and scientific affairs at Covance and vice president of global medical affairs and product safety at Hospira.
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Lars Dreiøe joins Sobi in senior quality and compliance role
Dreiøe has 20 years of experience in the biotech and pharmaceutical industries in quality, manufacturing, product safety and regulatory affairs.
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Chiltern hires Roche’s Andrew Monaghan to head pharmacovigilance
He was global head of safety operations at pharma company. Roche's Andrew Monaghan has swapped pharma for clinical research by moving to Chiltern. ... His strong leadership skills and extensive clinical experience will ensure our clients continue to
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Approximately 0 fully matching, plus 3 partially matching documents found.
Latest from PMHub
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Why are new medicinal products denied reimbursement in France?
1. The SMR ratings, which are the focus of this blog post, are awarded based on a review of the severity of the disease, the medicinal product’s safety, efficacy/effectiveness ... Failure to meet the desired efficacy or safety thresholds cannot, due to
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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
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A Bitter Pill?
commonly find that route of admin is often one of the first features they take into account (after efficacy and safety) when reviewing product profiles, and getting it right is fundamental ... In conclusion, optimising the route of admin is a fundamental
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Using new technologies to capture the patient's voice
world evidence that enables them to continue appraising the safety, efficacy and value of medicines over their full lifecycle. ... time. Trust (embracing such factors as perceived lack of transparency and product safety concerns), meanwhile, was
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RSSL
RSSL is a specialist scientific consultancy providing unrivalled expertise in analysis, product development and training. ... We can help you achieve your commercial objectives in key areas such as product safety and innovation as well as meeting the
More from PMHub
Approximately 0 fully matching, plus 6 partially matching documents found.
COVID-19 Updates and Daily News
Featured jobs
- Gilead agrees $21bn buyout of Immunomedics
- Regeneron launches phase 3 COVID-19 antibody trial in the UK
- FDA approves Roche’s Actemra COVID-19 trial
- Roche’s Ocrevus boasts positive long-term data in MS
- First patients dosed with COVID-19 vaccine from SpyBiotech and Serum Institute of India
- Low-dose LSD looks safe for Alzheimer’s patients, but will it work?
- InSite Mapping™ - a Novel Tool for Insight-gathering and Patient Journey Mapping
- Envision Pharma Group scoops two Silvers at the PM Society Digital Awards 2020
- Alone we can do so little, together we can do so much
- What can't we afford to treat anymore?
- OPEN VIE is awarded a Bronze Award at the PM Society Digital Awards 2020
- BioNTech bolsters COVID-19 vaccine capacity with Novartis deal
PMHub
SEVEN STONES
Seven Stones is a creative, independent healthcare communications agency of movers and thinkers. We've been doing health differently since 1991....
Latest intelligence
- InSite Mapping™ - a Novel Tool for Insight-gathering and Patient Journey Mapping
- Learn how a client engaged 18 rheumatologist advisors over 6 months to create a patient journey map for SLE....
- Alone we can do so little, together we can do so much
- Collaboration is at the heart of successful patient engagement and effective healthcare provision. But in such a complex, nuanced network, true collaborations are rare. So how can we, as an...
- 7 important considerations for creating an inclusive clinical trial website
- You might have noticed that all of us here at COUCH Health are big advocates for taking action to improve diversity and inclusion in the world of clinical research. ‘Taking...
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