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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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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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NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
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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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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.
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Fosaprepitant and Decitabine generics receive FDA approval
Generic treatments for blood/bone marrow disorders and acute nausea and vomiting associated with chemotherapy have gained FDA approval.
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EMA to review Picato after rise in skin cancer cases
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
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Developments in stability testing and evaluation
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
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Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
