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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.

Vertex rises on data for cystic fibrosis triple therapy

Vertex's Reshma Kewalramani. “These data mark a major milestone in our efforts to develop new CF medicines as they underscore the important clinical benefit that a triple combination regimen may

Latest news

Merck’s Bavencio joins first-line kidney cancer face-off

Taken together, while checkpoint inhibitors are now the standard of care in frontline RCC, PD-L1-positive patients tend to derive the most benefit,” notes Hsieh. ... In our view, combination with TKI could expand the clinical benefit of checkpoint
Alnylam seeks fast-track filing with biomarker data

Aminolevulinic Acid (ALA), a key biomarker likely to predict clinical benefit. ... FDA. to discuss the results and the overall benefit-risk profile for a potential NDA submission at or around year-end in support of an accelerated approval.”.
Imfinzi aces survival challenge in lung cancer

benefit in the “curative-intent, stage III NSCLC setting”, and is the first and only immunotherapy to be approved for these patients. ... The significant survival benefit observed using the PACIFIC regimen provides confidence and clear rationale for
ICER says Alnylam’s Onpattro should cost 90%-95% less

its price would have to be reduced 90%-95% to come into line with the benefit to patients. ... However, ICER goes on to say that there “may be uncertainties related to the translation of neurologic outcomes to longer-term clinical benefit, the
Biogen and Eisai claim mid-stage win for Alzheimer’s drug

They estimate– based on Eisai’s earlier communications on the drug and trial design – that the clinical benefit could be around 20-25% and “certainly very clinically meaningful” if so.

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Latest Intelligence

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
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.
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.
Taking a lean and careful approach

Chemotherapy and Pharmacology, which concluded its treatment regimen showed ‘encouraging clinical benefit’. ... Clinical trials. The company is moving cautiously and set its clinical trials in Israel, Italy, Turkey and Greece.
Strengthening market access deliverables by harnessing the patient journey

Topics such as the clinical value of new products, or what impact the product has on outcomes are relevant to multiple stakeholders. ... management, clinical benefit and economic/humanistic benefit.

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Latest appointments

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
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
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

Irritable Bowel Syndrome (IBS) Patient Insights

Irritable bowel syndrome in adults: diagnosis and management. NICE Clinical Guideline 61; 2017. ... International survey of patients with IBS: Symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit. J
What will the NHS’s Capped Expenditure Process (CEP) mean for pharma?

Balancing doctors’ demands for drugs that demonstrate strong clinical benefit and patient safety against medicines management teams’ focus on cost savings will be critical in CEP areas. ... In such areas, bringing together multi-disciplinary networks
How will the NHS’s new medicines savings drive affect pharma?

Engagement tactics must balance clinicians’ demand for products that show strong clinical benefit and patient safety against medicines management teams’ focus on the cost savings that can be generated by specific ... full benefit of expensive drugs,
Why and how doctors should be involved in startups

provide useful clinical insight that can benefit a startup.
Immunotherapy in oncology

These three states align with the clinical observations of response, stable disease and progression of disease. ... However, the group recognised that delayed responses and prolonged stable disease were having a significant survival benefit, underscoring