This page shows the latest product safety news and features for those working in and with pharma, biotech and healthcare.
In terms of safety, the company reported Rezlidhia was well tolerated, with an adverse event profile characteristic of symptoms or conditions experienced by patients with AML undergoing treatment. ... it intends to work with potential partners to further
Critically, the safety and immunogenicity profile of ABP 959 was comparable to Soliris. ... The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they have the potential to lower health
product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower health care costs. ... With proven similarities in efficacy and safety compared to the reference
to the reference product, which include assessments for safety, efficacy and quality. ... Secondary endpoints included change from baseline in BCVA at 48 weeks, change from baseline in FCB retinal thickness at 48 weeks, safety and immunogenicity.
For an EUA to be authorised, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product,” said Hahn. ... We work with sponsors so that additional data about the product’s safety and
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.
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Without a sufficiently flexible and redundant design, changing schedules at any point during collection, manufacturing, shipping and delivery can affect the entire workflow, potentially compromising patient and product safety. ... Common safety signals
o What are the product benefits? (untreated disease, efficacy, safety, price). ... efficacy, safety, pricing, medicine administration). Test messaging and language. o Engage and learn from the online community (without mentioning your product).
Customer expectations with regards to product safety and hygiene are also creating new trends within product packaging, trends which reverse the shift away from plastic that has occurred over recent years. ... Andy Barrett is Senior Product Manager at
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
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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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.
Dreiøe has 20 years of experience in the biotech and pharmaceutical industries in quality, manufacturing, product safety and regulatory affairs.
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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Any proposition must therefore continue to describe things like the clinical efficacy, safety and patient benefits of a product, the costed benefits it can bring to a given service, and how ... Conclusion. In short, Industry must now broaden its
The generation of data to show the significant benefits of a drug has always been a complex, intricate process, but essential to ensure a product’s approval, support the overall value ... Traditional randomized clinical trials (RCTs) are considered the
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
product profiles, and getting it right is fundamental to a product’s eventual uptake and market share. ... In conclusion, optimising the route of admin is a fundamental step in the path to market for any pharmaceutical product.
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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Life is a creative communications agency offering multi-channel solutions for the healthcare industry. We use a storytelling approach to turn...