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clinical benefit
This page shows the latest clinical benefit news and features for those working in and with pharma, biotech and healthcare.
Latest news
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FDA starts speedy review of Lynparza plus Avastin in ovarian cancer
its formulation of fish oil-derived omega-3 carboxylic acids – in mixed dyslipidaemia because it was unlikely to show a clinical benefit on cardiovascular outcomes.
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Apellis jumps as pegcetacoplan tops Alexion’s Soliris in PNH trial
approval. Much will hinge on whether the FDA will accept a rise in haemoglobin levels as sufficient evidence of clinical benefit on its own, or as is likely will need to
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NICE rejects Akcea’s rare inherited disorder drug Waylivra
Although NICE did not raise any concerns about Waylivra’s safety, it did take issue with it long-term clinical benefit, as well as its steep price. ... Despite acknowledging that clinical trials of the drug demonstrated some benefit in the short-term,
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AbbVie’s JAK inhibitor Rinvoq approved in EU for rheumatoid arthritis
Low disease activity and clinical remission rates were consistent across the patient populations. ... marginal clinical benefit’ over Humira, but with a more costly price tag.
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FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection
The FDA now says that Vyondys 53 (golodirsen) is “reasonably likely” to have a clinical benefit in DMD and that its decision takes into account “the potential risks associated with the ... Use of the accelerated approval pathway will make Vyondys
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Latest Intelligence
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Alzheimer’s: the search for a cure
The analysis of the expanded data set for one of the phase 3 trials, EMERGE, linked aducanumab to improvements on a clinical dementia scale. ... The preponderance of the data indicates aducanumab doesn’t provide a clinical benefit,’ Skorney wrote in
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Novel endpoints in the digital age
Every clinical trial has an endpoint, a measure used to determine if the drug in question provides therapeutic benefit. ... measure safety, efficacy and clinical benefit of a medicine in a trial.
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The European Medicines Agency: PRIME’d for access?
The scheme. The PRIME scheme is for medicines that have real promise, defined by the EMA as medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients ... Companies who want to benefit from the scheme have to
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Can new data aggregators shift the balance of power away from pharma?
This could have far-reaching consequences for some players in the pharmaceutical industry who may find their product pricing to be untenable when the cost/clinical benefit calculus becomes totally transparent.
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Patient recruitment and engagement standards
And the reality: 50% of clinical research sites don’t recruit a single patient. ... A number of studies have revealed that awareness changes patients’ perceptions about clinical trials, enrolment and the risk/benefit ratio of getting involved.
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Latest appointments
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Dr Irina Antonijevic joins vasopharm
In this role, Dr Antonijevic will be responsible for advancing the clinical development of the cerebrovascular specialist's lead orphan drug candidate, VAS203. ... Not only will we benefit from her clinical capabilities in our ongoing pivotal study of
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ICON's CEO named chair of ACRO
Trade body for clinical research organisation elects Ciaran Murray. The global trade body for clinical research organisations has elected ICON's CEO Ciaran Murray as chairman. ... I look forward to continuing the work that ACRO has done in promoting our
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Industry veteran Louis Nisbet joins Sygnature board
The UK-based clinical research organisation (CRO) will benefit from Dr Nisbet's extensive experience in the life sciences industry, which includes spells in research at Roche, Glaxo and SmithKline.
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Latest from PMHub
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Using behavioural psychology to improve patient recruitment
the areas in which sponsors can use these emotions to their benefit are:. ... It’s important to give participants a personal reason for taking part in clinical trials.
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How do companies prepare for reimbursement?
The same applies to many more therapeutic areas. Moreover, even when a substantial clinical benefit is proven, payers will tend to position the product in second line, to be used when ... In some cases, for instance, when it will be essential to show
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Are you using Patient-Reported Outcomes (PROs) in your oncology trials? If not, why not?
A recent blog, published by Sarah Tressel Gary and Rinah Yamamoto called “Patient-Reported Outcome Data in Oncology Trials - Part 2: Clinical Benefit and Patient Preference”, has sparked our interest. ... assessing the clinical benefit of oncology
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WHITE PAPER: Patient nonadherence – the $637bn paradox
study[13] the benefit common to both was a 50% reduction in mortality risk. ... Most apparent may be the monetary cost of medicines which, through nonadherence, are wasted and don’t lead to their intended clinical benefit.
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RWE Blog 2: Payers use real-world data cautiously
uncertainties about the criteria to identify the population of patients most likely to benefit from the product in clinical practice. ... the product hasn’t been studied in the normal combination. selected patients didn’t include the frail ones, so
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COVID-19 Updates and Daily News
Featured jobs
- EMA clears BMS’ oral multiple sclerosis drug Zeposia
- Biogen delays filing of Alzheimer’s drug, which hits its share price
- EMA clears BMS’ oral multiple sclerosis drug Zeposia
- Alnylam and Vir plan gene-silencing attack on COVID-19 virus
- ASCO: Momentum gathers behind next wave of CAR-T therapies
- Merck’s Keytruda hits the mark in triple negative breast cancer
- Moderna to begin pivotal phase 3 trial of COVID-19 vaccine in July
- Impetus Digital Fireside Chat with Susanne Somerville of Chronicled
- Impetus Digital Fireside Chat with Bechara Saab of Mobio Interactive
- FDA delays review of Novartis’ MS drug ofatumumab
- Sanofi makes ‘best-in-class’ claim for Sarclisa in myeloma
- Q&A: Kay Wesley
Latest intelligence
- Working together against COVID-19
- Analysing social media conversations to see what HCPs are saying online about the global pandemic...
- Vicky Bramham, Managing Director at OPEN Health PR shares tips on media relations during COVID-19
- Vicky speaks with freelance health journalist Jacqui Thornton who gives her expert view on how best to approach media relations during this unprecedented time....
- Are biobetters a market access opportunity?
- Biobetters are biologics that have been improved compared to the marketed originator, for example in efficacy, safety, tolerability or dosing regimen....
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