DSM to honour Australian biologics plant contract post-Patheon merger
Operations will continue and may even be enhanced at DSM’s Australian taxpayer-funded biologics plant following a merger with Patheon, the Queensland Government says.
Archives for March 7, 2014
Seven year market exclusivity? Industry hits out at Obama's pro-biosimilar Budget
Proposals in President Obama’s 2015 budget to reduce the market exclusivity period for biologics could save the US $4bn (€2.9bn) but have been labelled unproductive by industry groups.
US FDA, EMA offer similar explanations for ADC regulations
The EMA and US FDA say the chimeric nature of antibody drug conjugates (ADC) does not make them any harder to regulate and that existing guidelines for small and large molecule drugs are sufficient.