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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.

Gilead’s remdesivir not included in WHO’s COVID-19 drug scheme

Gilead’s remdesivir not included in WHO’s COVID-19 drug scheme

In the final day 29 results, the antiviral drug plus standard therapy was able to cut the time to clinical recovery by five days compared to placebo, with a median time ... journals validating the clinical benefit of remdesivir”.

Latest news

  • FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients FDA approves Gilead’s remdesivir for hospitalised COVID-19 patients

    In the final day 29 results, remdesivir plus standard-of-care treatment were able to cut the time to clinical recovery by five days compared to placebo, with a median time ... The drugmaker told Reuters that “the emerging (WHO) data appears inconsistent

  • WHO trial casts doubt on remdesivir's efficacy WHO trial casts doubt on remdesivir's efficacy

    The emerging (WHO) data appears inconsistent, with more robust evidence from multiple randomised, controlled studies published in peer-reviewed journals validating the clinical benefit of remdesivir,” Gilead told Reuters. ... In addition to the 62%

  • Novartis’ MS therapy Mayzent approved by NICE Novartis’ MS therapy Mayzent approved by NICE

    Initially, NICE turned down Mayzent due to a lack of clinical evidence for its clinical benefit in SPMS and also a lack of cost-efficiency evidence. ... unmet clinical need,” said Meindert Boysen, deputy chief executive and director of the Centre for

  • Janssen’s EGFR-targeting treatment regimen shows early benefit in lung cancer Janssen’s EGFR-targeting treatment regimen shows early benefit in lung cancer

    The CHRYSALIS study investigators assessed the efficacy of the combination treatment using overall response rate (ORR) markers, as well as clinical benefit rate, duration of response and the safety profile of ... response, representing a clinical benefit

  • FDA approves Sarepta rival NS Pharma’s Duchenne drug FDA approves Sarepta rival NS Pharma’s Duchenne drug

    Following the approval, NS Pharma is required to conduct a confirmatory clinical trial to demonstrate the drug’s clinical benefit. ... Like NS Pharma, Sarepta is conducting a confirmatory trial of Vyondys 53 after winning initial approval to determine

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Latest Intelligence

  • Addressing the payer-regulator evidence gap in early-stage cancer Addressing the payer-regulator evidence gap in early-stage cancer

    Baseline survival times are longer in early-stage disease, and other measures of clinical benefit become relevant such as avoidance of recurrence and quality of life. ... Which alternative endpoints can assess clinical benefit in early-stage disease?

  • Alzheimer’s: the search for a cure 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

  • Novel endpoints in the digital age 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.

  • The European Medicines Agency: PRIME’d for access? 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? 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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Latest appointments

  • Dr Irina Antonijevic joins vasopharm 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 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 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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