FDA approves Vimizim for rare enzyme disorder
The US Food and Drug Administration has approved Vimizim from BioMarin Pharmaceutical Inc to treat a rare congenital enzyme disorder that can lead to problems with bone development, growth and mobility.
The US Food and Drug Administration has approved Vimizim from BioMarin Pharmaceutical Inc to treat a rare congenital enzyme disorder that can lead to problems with bone development, growth and mobility.
Summit Plc is proposing to raise up to £21 million in a private share placement directed at institutional and other investors in the US and Europe. The funds will advance compounds for Duchenne Muscular Dystrophy and C. difficile infections.
Paris-based Sofinnova Partners has seen another company from its Sofinnova Fund VI make an initial public offering of shares in the US – this time for Flexion Therapeutics Inc which is developing products for pain.
Rhenovia Pharma SAS has raised €540,000 in a Series B financing round from existing investors to support development of its technology for predicting the safety of new pharmaceutical compounds in patients with neurological diseases.
Actelion Ltd, which has a growing franchise in pulmonary arterial hypertension (PAH), reported a 4% rise in revenue in 2013 but net income soared by 49.2% on flat operating expenses. During the year it won regulatory approval for the new PAH drug Opsumit.
H. Lundbeck A/S, which specialises in treatments for neurological disorders, reported a 3% increase in revenue to DKK 15.3 billion for 2013, but earnings before interest and tax fell by 7% to DKK 1.6 billion reflecting generic competition.
Circassia Ltd, which is testing a novel immunotherapy for four major allergies, has announced plans to float on the main market of the London Stock Exchange. At an estimated £175 million, the initial public offering would be one of the UK’s largest.
Shire Plc of Ireland said that two pivotal Phase 3 studies of the central nervous system drug Vyvanse (lisdexamfetamine dimesylate) have failed to show efficacy in patients with major depressive disorder (MDD).
Sanofi SA reported a 5.7% decline in net sales for 2013 to €32.9 billion and a 24% drop in net profit attributable to shareholders to €3.7 billion as product sales declined in all geographical areas apart from the emerging markets.
Innate Pharma SA of France has purchased rights to an immune checkpoint inhibitor from Novo Nordisk A/S of Denmark that is ready for Phase 2 development in oncology. Checkpoint inhibitors are currently attracting a lot of interest because they have shown an ability to thwart tumours.