From 1 January 2015, the European Medicines Agency will begin to publish clinical data used by companies to support their applications to market new drugs in the EU – a policy that is expected to have wide-ranging implications for medicines research across Europe.
For the first time, two patients suffering from a rare genetic blood disorder, for which there is currently no approved medicine, participated in a discussion at the main scientific committee of the European Medicines Agency where a candidate medicine for their disease was being reviewed.
The European Medicines Agency has given positive opinions for 15 new medicines including treatments for hepatitis C infection, Cushing’s syndrome and for non-small cell lung and gastric cancers. The decisions were announced on 26 September.
The US Food and Drug Administration has issued its first approval for a checkpoint inhibitor that targets the T cell receptor programmed death 1 or PD-1 for the treatment of advanced melanoma. The drug, Keytruda (pembrolizumab), was developed by Merck & Co Inc.
The European Commission has granted a marketing authorisation for a new treatment for HIV, Triumeq, that combines the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
Mesenchymal stem cells (MSC), a type of adult stem cell, have properties that make them potentially suitable for a wide range of therapies. Depending on how they are cultured, they can produce cartilage, bone and fat and help control inflammation and immunity.
The Food and Drug Administration has approved the use of Avastin (bevacizumab) with chemotherapy to treat advanced cervical cancer – the first biologic to be authorised for this indication in combination with other agents.
In separate decisions, regulatory authorities in the US and Europe have paved the way for the introduction of two new medicines for different blood cancers – substantially increasing the treatment options for patients with a number of rare cancers.
A Phase 3 trial of a combination therapy for metastatic melanoma has been stopped early because an interim analysis showed an overall survival benefit for the treatment group compared with the control, according to the developer GlaxoSmithKline Plc.
Pharming Group NV of the Netherlands has received approval to market its drug for hereditary angioedema (HAE), Ruconest, in the US following approval by Food and Drug Administration. The approval comes nearly four years after the drug was authorised for marketing in Europe.