A federal judge has denied Sanofi-Aventis 's request for a preliminary injunction that would have directed the US FDA to suspend and withdraw its approval of a generic version of Lovenox (enoxaparin sodium) from Sandoz (Novartis) and partner Momenta ...
Hikma Pharmaceuticals of Jordan says its strategy of expansion and diversification has led to it reporting an increase in revenue for the first half ended 30 June to $357.7 million (+11%) and a rise in adjusted operating profit to $73.2 million ...
The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from ...
NICE, the National Institute of health and Clinical Excellence in England and Wales, has again rejected Roche's Avastin (bevacizumab) for metastatic colorectal cancer. An amended patient access scheme submitted by the company failed to convince the ...
Dr Reddy's Laboratories has launched the first cut-price biosimilar darbepoetin alfa on the Indian market. The product, sold as Cresp, has been approved in India for the treatment of anaemia due to chronic kidney disease and anaemia due to ...
