Fresenius: US supply from troubled Indian plant to restart in Q3
Fresenius Kabi has recommenced production at a troubled Indian facility and expects to start shipping APIs to the US in the next few weeks.
Archives for August 4, 2014
EMA concept paper focuses on quality control with animal tests
The European Medicines Agency (EMA) has issued a concept paper on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of the...
Icon's robust Q2 driven by strategic partners and new clients
Icon has picked up new clients and expanded existing contracts in a robust Q2, but the CRO says it has seen no overall shift in its client concentration with strategic partners continuing to make up half its revenues.
Roche re-enters gene silencing space with $250m LNA acquisition
Roche has renewed its interest in gene silencing drugs, paying $250m (€187m) for Santaris Pharma including its ‘antisense’ Locked Nucleic Acid (LNA) platform.
US, foreign API facilities to see FDA fees spike in 2015
US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.
Pfizer, Roche join consortium of adaptive trial sponsors
Pfizer and Roche have joined a consortium of clinical trial sponsors that are looking to design and implement adaptive trial designs. The consortium was partly founded by CRO Icon’s new subsidiary Aptiv Solutions.