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First treatment for children with rare vasculitis diseases approved
Rituxan (rituximab) is the first approved treatment for children with rare vasculitis diseases, in which a patient’s small blood vessels become inflamed.
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Thermally stable chikungunya vaccine developed by researchers
Researchers have developed a chikungunya vaccine that can be stored at warm temperatures and manufactured quickly, which has been validated in animal models.
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First oral GLP-1 treatment for type 2 diabetes approved
With the approval of the treatment, Rybelsus, there is a new option for treating type 2 diabetes without injections.
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Treatment for dialysis patients with CKD anaemia approved in Japan
A treatment for anaemia associated with chronic kidney disease in dialysis patients has been approved in Japan.
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Hereditary angioedema treatment recommended by NICE
Lanadelumab, a preventive treatment for hereditary angioedema, has been recommended as a cost-effective use of NHS resources.
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Company sues FDA over rejecting opioids intended to deter abuse
Pharmaceutical Manufacturing Research Services has filed a lawsuit against the FDA after it rejected its application for opioids with updated labelling and appearance, meant to discourage misuse.
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Multiple myeloma treatment granted Orphan Drug Designation
Orphan Drug Designation has been given to bispecific antibody candidate, GBR 1342, for the treatment of multiple myeloma.
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New flu patch could lead to needle-free vaccination methods
New vaccine patch has showed no negative side effects and could lead to a replacement of needle-based vaccination methods.
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EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
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Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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Treatment approved for young children with severe eosinophilic asthma
Nucala is the first biologic approved in the US for six- to 11-year-old children with severe eosinophilic asthma by the FDA.
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Showcasing a monthly injectable HIV treatment
Janssen’s Brian Woodfall discusses the pharmaceutical company’s research process for their monthly injectable HIV treatment and their predictions for the future of the condition.
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FDA grants regulatory approval for hypoglycemia treatment
GVOKE injection has received regulatory approval from the FDA for the treatment of severe hypoglycemia in patients with diabetes.
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Metastatic NSCLC therapy, tepotinib, given Breakthrough Designation
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.
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Fast Track designation granted to fosmanogepix for seven indications
Both the intravenous and oral formulations of the antifungal candidate, fosmanogepix, have been granted Fast Track designation by the FDA.
