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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Cosentyx® (secukinumab) meets clinical trial endpoints
Cosentyx®, a treatment for an inflammatory disease has met its primary endpoints in patients during a Phase III trial.
Demand for containment facilities and manufacturing to grow
The market for containment facilities and containment manufacturing will increase in the future, due to a growing demand for oncology treatments.
Fast Track designation given to heart failure treatment
Farxiga (dapagliflozin) has been given Fast Track designation by the FDA to reduce the risk of cardiovascular death.
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.
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.
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.
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.
Purdue Pharma files for bankruptcy protection in the US
Purdue has filed for bankruptcy protection after a settlement offer from the company over the opioid crisis was rejected by 24 states.
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.
Kenya launches phased malaria vaccine pilot programme
Kenya has become the third African country to introduce the world’s first malaria vaccine into the country, in a phased pilot programme.
FDA emphasises need for adverse event reporting of compounded drugs
The FDA says that even though it recognises the importance of compounded drugs, they also pose a risk to patient safety.
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.
Germany imports largest ever shipment of EU medicinal cannabis
An import of medicinal cannabis from Portugal to Germany signifies the largest quantity ever moved within the EU, highlighting a surge in the medicinal cannabis products market.
UK to launch seven data hubs to garner insights for improved healthcare
The seven centres will aid disease research and clinical development, improving access to patient data for studies.
