New safety information has been added to the label for the HIV therapy, Invirase (saquinavir), describing potentially life-threatening side effects on the heart when used with Novir (ritonavir), the US Food and Drug Administration announced.
GlaxoSmithKline Plc reported a sales decline of 2% in the third quarter of 2010 to £6.8 billion. However, excluding events such as the suspension of Avandia (rosiglitazone) in Europe and restrictions in the US, sales rose by an underlying 6%.
Novartis International AG has reported a 10% rise in net income to $2.3 billion in the 2010 third quarter on net sales of $12.6 billion. Recently launched products accounted for 20% of third-quarter sales, up from 15% a year earlier.
OncoMethylome Sciences SA, which recently re-launched itself as MDxHealth, is shifting its business strategy away from the development of biomarker services for third parties to focus on stand-alone diagnostics for the detection and prognosis of cancers.
Sygnis Pharma AG has announced a three-for-one reverse split of its shares in a move that will allow the German biotech company to resume equity financing.
The US Food and Drug Administration has approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with atrial fibrillation. The product has been developed by Boehringer Ingelheim GmbH.
Eli Lilly and Co, Amylin Pharmaceuticals Inc and Alkermes Inc have received a ‘complete response letter’ from the US Food and Drug Administration for Bydureon which is intended to improve glycemic control for adults with Type 2 diabetes.
GlaxoSmithKline Plc is to pay €10 million to the Italian medical charity, Fondazione Telethon, for access to a new gene therapy that can be carried out on stem cells taken from a patient’s own bone marrow. GSK will investigate the therapy for rare diseases.
Cellectis SA of France has signed two separate non-exclusive agreements with iPS Academia Japan Inc giving it access to the induced pluripotent stem cell patent portfolio arising from the work of Shinya Yamanaka at the University of Kyoto.
Genmab A/S said that, based on discussions with regulators, it has sufficient data to file a marketing authorisation application in Europe for zalutumumab for the second-line treatment of patients with head and neck cancer.