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European Commission approves Sunosi® (solriamfetol)
EU marketing authorisation has been given to Sunosi (solriamfetol) for excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea.
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Researchers develop vaccine formulation with long shelf life
A study has demonstrated in mice the success of a vaccine design which can be stored at room temperature for long periods of time.
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The intricacies of rising drug prices in the US
Following 250 US drug price increases in 2020 already, this article explores why costs are rising, what changes could ensure brand reputations remain intact and what manufacturers can do to ensure they get their share.
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New report shows impressive innovation in HIV first-in-class pipeline
A new report has shown a high level of novelty and diversity for the HIV first-in-class pipeline which targets drug resistance and latency reversal.
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Blockchain will play a pivotal role in the healthcare industry, report predicts
A new report has predicted that, even though the healthcare sector has been slow on the uptake, blockchain will play a pivotal role, creating new ways for pharmaceutical stakeholders to exchange information.
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Gilteritinib not recommended by NICE for AML treatment
NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
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Recommendations made by EMA to unlock big data potential
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
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‘Super-human’ red blood cells could revolutionise drug delivery
Modified ‘super-human’ red blood cells containing therapeutic compounds have been developed by researchers as a novel form of drug delivery.
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First human clinical trial to study cannabinol initiated
The first company to study cannabinol as an active pharmaceutical ingredient has launched its Phase I clinical trial.
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Immuno-oncology and personalised medicine to drive pharma in 2020
A survey of industry professionals states they expect immuno-oncology therapies and personalised medicines to continue to shape the pharmaceutical industry in the coming year.
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PQE GROUP, the international quality solution provider, at Interphex to consolidate its presence in US
PQE Group, the consulting company in the pharmaceutical field, based in Italy, has chosen “Interphex” to strengthen its presence on the US market.
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Lack of new antibiotics threatens battle against drug-resistant infections, WHO says
The World Health Organization (WHO) has released new reports which state that a lack of innovation in new antibiotic development is undermining efforts to combat drug-resistant infections.
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UK accounts for 12 percent of global cell and gene therapy clinical trials
New research has found that the cell and gene therapy clinical environment in the UK has encouraged commercial sponsorship from around the world.
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Summarising 2019: a year of firsts for the EMA
The EMA was a proactive force in 2019, granting marketing authorisation for a range of drugs. This article highlights some of the most important advancements made by the agency last year.
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Fast Track Designation granted to decompensated heart failure treatment
The US FDA has granted Fast Track Designation to APD418, which is in development as treatment for decompensated heart failure patients.