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.
News
Summit proposes to raise up to £21 million
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.
Sofinnova portfolio company raises $65 million
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 secures Series B funding
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 reports big gain in net profit
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.
FDA supports novel design
The Food and Drug Administration has given an insight into its attitude toward novel trial designs in a commentary written by Commissioner Margaret Hamburg and published online on 6 February.
Lundbeck’s 2013 results mixed
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 plans IPO in London
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.
Phase 3 studies of Vyvanse in depression fail – Shire
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 reports 2013 decline in sales and profit
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.