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Malaria vaccine clinical trial for pregnant women reports promising results
The results of a clinical study for a gestational malaria vaccine has shown that the treatment is "well tolerated" and can produce an immune response.
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Medreich ranitidine tablets recalled due to possible NDMA contamination
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
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FDA grants priority review to selpercatinib New Drug Application
Priority review has been given to the NDA for selpercatinib to treat advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.
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Video: Data Prep of Million Data Points at Janssen
Watch Data Scientist Patrick O’Sullivan of Janssen describe how they reduce the amount of time spent preparing data for their million data point systems.
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AstraZeneca announces plan for zero carbon emissions by 2025
AstraZeneca’s new carbon emission plan includes a 100 percent electric vehicle fleet and a 50 million tree reforestation plan.
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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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Investigational New Drug application approved for LINCL treatment
The FDA has granted Investigational New Drug application to PLX-200 to treat late infantile neuronal ceroid lipofuscinosis (LINCL).
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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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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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Edible security tag for drugs developed to combat counterfeits
Researchers have created a unique edible film to be added onto the surface of drugs which can produce a security key, preventing counterfeits from reaching patients.
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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.
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NICE requests more data on Keytruda for head and neck cancer treatment
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
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FDA approves sNDA for candidiasis treatment in paediatric patients
Supplemental new drug application (sNDA) has been approved for an expanded indication of MYCAMINE® for the treatment of invasive candidiasis in paediatric patients under four months old.
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FDA announces one nizatidine and two ranitidine voluntary recalls
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
