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Breakthrough therapy for cystic fibrosis approved by FDA
Trikafta is the first approved treatment that is effective for patients 12 years and older with the most common cystic fibrosis mutation.
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HER2-positive metastatic breast cancer treatment granted Priority Review
Priority Review has been granted for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of HER2-positive metastatic breast cancer.
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First non-injectable treatment for severe hypoglycaemia recommended
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
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XARELTO® approved to help prevent blood clots
The FDA has approved XARELTO® (rivaroxaban) to help prevent blood clots in acutely ill medical patients.
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Making Science Work at CPhI Worldwide 2019
CPhI Worldwide now comprises six individual pharma events and more than 20 dedicated zones.
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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.
