The US Food and Drug Administration has approved a new recombinant fusion protein, Eylea (aflibercept), to treat patients with wet, age-related macular degeneration, a leading cause of vision loss and blindness in the elderly.
The US Food and Drug Administration is revoking its approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use. The decision was announced by Commissioner Margaret Hamburg on 18 November 2011 following a long review of the drug’s use in patients.
Zealand Pharma A/S, a developer of peptide drugs, raised its guidance for 2011 revenue and other operating income in its interim report for the first nine months, suggesting that it would break even on an operating basis for the year.
The Swiss molecular diagnostics company, Biocartis SA, has raised €71 million in a Series C round to support the development of its products including an integrated diagnostic that is expected to be launched in 2013.
Oxyrane UK Ltd has raised $26.5 million in a Series D financing to support the development of its enzyme replacement therapies for lysosomal storage diseases. The round was led by Morningside and joined by Forbion Capital Partners.
The European Medicines Agency has recommended the suspension of all medicines containing buflomedil, a vasoactive agent, which are used to treat the symptoms of chronic peripheral arterial occlusive disease. They have been on the market since the 1970s.
The Pharming Group NV, which is starting to receive income from the rollout in Europe of its recombinant C1 inhibitor for hereditary angioedema (HAE), reported revenue and income from continuing operations of €2.3 million for the first nine months of 2011.
The US Food and Drug Administration has approved Jakafi (ruxolitinib) for myelofibrosis. The drug is a JAK inhibitor which is designed to block the JAK1 and 2 enzymes which are involved in regulating blood and immunological functioning.
Bavarian Nordic A/S, which develops vaccines for cancer and infectious diseases, reported a large pick-up in third quarter revenue and said it will reach its full-year target of about DKK 500 million (€67.2 million). For the year, it expects a pretax loss of DKK 350 million.
Geron Corporation, which launched the first human study of an embryonic stem cell therapy in the west, has decided to leave the stem cell field citing the unfavourable financial environment. It is stopping its trial in patients with spinal cord injury.