As the partial US government shutdown continues into its third week, the FDA...
Eisai and Purdue Pharma seek US approval for lemborexant to treat insomnia
Eisai and its partner Purdue Pharma have submitted new drug application to the US Food and Drug Administration (FDA) seeking approval for lemborexant to treat insomnia, a sleep disorder.
US government shutdown: should the FDA go independent?
As the partial US government shutdown continues into its third week, the FDA has been operating at reduced capacity, curbing both domestic food facility inspections and drug submissions.
The Future of the Pharmaceutical Industry
Ever participated in one of those benchmarking exercises? When a (usually) fresh-faced consultant asks a lot of questions and fills in a spreadsheet comparing what you do with your competitors? Well, beware.
FDA grants breakthrough therapy status to crizanlizumab
Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the use of crizanlizumab (SEG101) to prevent vaso-occlusive crises (VOCs) in sickle cell disease (SCD) patients of all genotypes.
Daiichi Sankyo receives Japanese marketing approval for two drugs
Daiichi Sankyo has obtained marketing approval in Japan for its minnebro and tarlige tablets to treat hypertension and peripheral neuropathic pain (PNP) respectively.
Janssen seeks EMA approval for Stelara to treat ulcerative colitis
Janssen Pharmaceutical has submitted an application to the European Medicines Agency (EMA) for the approval of its Stelara (ustekinumab) medicine to treat adults with moderately to severely active ulcerative colitis (UC).
NHS Long Term Plan: focus on R&D and digital innovation
The UK Government has launched the NHS Long Term Plan laying out the health service's focuses for the next decade. Two of the most interesting aspects are better focused R&D and making use of the latest technological developments to improve outcomes for patients.
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