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FDA to promote development of coronavirus diagnostics and countermeasures
The US FDA has revealed its action plan to aid in the development and advancement of diagnostics and medical countermeasures to combat the novel coronavirus 2019.
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Therapeutics
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Spotlight: a dispersible tablet formulation to treat HIV in children
A novel formulation for dolutegravir has been developed to improve HIV treatment options for children. Dr Kimberly Smith from ViiV Healthcare discusses the benefits of this new dispersible tablet.
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FDA approves Tepezza for the treatment of thyroid eye in adults
The US FDA approved Tepezza (teprotumumab-trbw), the first treatment for thyroid eye, on the basis of two trials in which the drug improved eye protrusion in patients.
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NRDL list could lead to increased access to innovative drugs in China
China has started to regularly update its National Reimbursement Drug List (NRDL) which could lead to new opportunities for innovative drug manufacturers to foray into the Chinese market, say researchers.
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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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‘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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Less than half of US clinical trials comply with reporting regulations
Researchers have found that only 41 percent of trials reported their findings with a year after completion and suggest that over $4 billion in fines could have been collected in just 12 months.
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Regulatory expansion submitted for SPRAVATO® (esketamine) nasal spray
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
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NICE recommends olaparib tablets for platinum-sensitive cancer patients
NICE has recommended olaparib tablets (Lynparza, AstraZeneca) for adults with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer with a BRCA1 or BRCA2 mutation.
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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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First living robots, called ‘xenobots’, could be used in drug delivery
Using embryonic stem cells from frogs, scientists have created living robots; called xenobots, these organisms are able to heal after injury and could be the future of drug delivery.
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Nanoparticle gene therapy drug delivery for paediatric brain cancer tested in mice
A study has shown that PBAE nanoparticles could replace viral vectors in gene therapies and provide a safe treatment option for paediatric brain cancer patients.
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Cancer immunotherapy market to hit $115bn by 2023, says report
New research analysis has predicted that immunotherapy will become the oncology treatment of choice, with the market reaching $115 billion by 2023.
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The Advance Value Framework: evaluating the benefits of novel medicines
Researchers have proven their methodology for drug benefit evaluation to be effective as a decision support tool in a study with several European drug evaluation bodies.
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Adopting new guidelines could get medicines from CID trials to patients faster
The ECMC has published guidelines for Complex Innovative Design trails which could improve the conduct, quality and acceptability of oncology studies, enabling patients to get access to new medications more quickly.
