The US Food and Drug Administration has turned down Novo Nordisk A/S’s application to market the long-acting insulin drugs, Tresiba and Ryzodeg, pending the supply of more data on cardiovascular risk. It has also cited the Danish company for manufacturing violations.
e-Therapeutics Plc, which develops drugs that reach several optimized targets, has raised £40 million in a private placement with existing and new institutional investors. The placement is subject to existing shareholders waiving their preemption rights.
Up to £50 million is expected to be made available for British life science following the setting up of a new fund that will seek to identify early-stage technologies with global commercialistion potential.
Sanofi SA has reported a 4.7% rise in net sales to €34.9 billion for 2012 despite losing an estimated €1.3 billion to generic competition. However, the near-term outlook is not favourable. Sales in the fourth quarter were barely changed at €8.5 billion and the French pharmaceutical company estimated that the loss of exclusivity of just two drugs (Plavix and Avapro) would impact sales by around €800 million in the first half of 2013.
Eli Lilly and Company has decided to stop development of the monoclonal antibody, tabalumab, in rheumatoid arthritis due to lack of efficacy. But it will continue to investigate the same drug as a possible treatment for systemic lupus erythematosus.
Elan Corporation Plc has announced an agreement to sell its 50% share in the jointly owned multiple sclerosis drug, Tysabri (natalizumab), to its partner Biogen Idec Inc for $3.25 billion upfront in cash plus double-digit, tiered royalties.
GlaxoSmithKline Plc plans to realise annual cost savings of at least £1 billion by 2016 through the introduction of new technology for manufacturing and research and development and by furthe
The Roche Group said its candidate antibody for haematological cancers, obinutuzumab, met its primary endpoint in the first stage of a Phase 3 trial and will now move on to be compared directly with MabThera/Rituxan (rituximab), the standard of care for leukaemias and lymphomas.
GlaxoSmithKline Plc has taken control of its publicly-listed consumer healthcare subsidiary in India in a transaction valued at about £568 million. As a consequence, it now owns 72.5% of GlaxoSmithKline Consumer Healthcare Ltd, up from 43.2% previously.
Novo Nordisk A/S has raised its target for operating margin as sales of its diabetes products continue to show robust growth led by its modern insulins and Victoza, the company’s GLP-1 therapy for type 2 diabetes. The new operating margin target is 40%, up from 35% previously.