Keyword: European Medicines Agency
Biocon says it has won EMA manufacturing approval for a $275 million plant in Malaysia where it will make insulin for export to the EU.
Mylan and Biocon, whose Herceptin biosimilar was to be considered by the FDA Sept. 3, has had its target date delayed three months.
A generics maker in the U.K. had its manufacturing certification pulled after regulators found data-reporting issues.
Merck KGaA has won European approval for its oral MS drug, but competing with more established rivals won't be easy.
Biocon, which pulled its EU application for a Herceptin biosimilar because of manufacturing issues, expects to resubmit to authorities next quarter.
French drug regulators slapped Chinese API maker Chongqing Succeway Pharmaceutical with a warning letter and issued a recall following an inspection last month.
Mylan and Biocon have hit a stumbling block that will delay potential approval of their biosimilar of Roche’s Herceptin in Europe.
Facing persistent manufacturing difficulties, U.S.-based Pacira will stop producing chemo drug DepoCyt, laying off some employees in the process.
The European Medicines Agency has approved the continuous manufacturing production of the HIV drug Prezista (darunavir) by Janssen Pharmaceuticals, a unit of Johnson & Johnson.
Drug regulators from Europe, the U.S. and Japan formed an antibiotic alliance; SK Biotek purchased an API plant by BMS; JSR nabs Selexis.