Drop in first-cycle approvals may be “new reality,” says Parexel
Parexel Consulting has released its annual analysis of FDA new drug review trends, which indicates there is a “new normal” emerging in the drug review and approval process.
Archives for October 26, 2010
Puerto Rico’s tax cuts to “hinder” offshore biopharma firms
PhRMA says a new Puerto Rico law to tax offshore manufacturers will “dramatically hinder” biopharma companies.
GSK fined $750m for old Puerto Rico plant violations
UK-drugmaker GlaxoSmithKline (GSK) must pay $750m to settle a law suit criticising manufacturing practices at plant in Cidra, Puerto Rico that was shut down in 2009.
Biocon investing $161m in Malaysian biomanufacturing site
India-based Biocon is investing RM500m ($161m) in Malaysia to establish a cGMP biomanufacturing and R&D facility.
FDA may never have inspected 88 per cent of Chinese sites
The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.
PPD sees Op income and revs climb in Q3; signs new collaborations
PPD signs clinical imaging and formulation development collaborations, reorganises reporting units and cites “improved performance in emerging markets” and spending controls as key to third quarter gains.
Lonza boosts capacity use but tough regulators add volatility
Lonza is seeing increased capacity utilisation and project pipelines in custom manufacturing but warned more stringent regulatory approval is creating volatility.