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GENET-news articles on GE rabbits

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2009-09-04 |

Pharming re-submits marketing application for Rhucin from GE goats

Dutch biotech firm Pharming said on Thursday it had lodged its application for marketing approval for its lead product Rhucin with the European Medicines Agency (EMEA). [...] But Pharming said it has followed up on and addressed concerns raised by the EMEA during the former evaluation procedure in 2007, adding that the size of the clinical database has been significantly expanded.

2008-10-09 |

Pharming (Netherlands) provides new data on Rhucin drug from GE rabbits

During the presentation of Dr. Pinto, which will be available on Pharming’s website, data will be shown that illustrate the marked progress made over the last few months in the development of its late stage product, Rhucin®. In particular, much focus was given on the analysis of patients receiving repeat treatments of Rhucin® and patients suffering from severe attacks which were of concern to regulatory authorities earlier this year.

2008-08-18 |

The future of biotech is in rabbits, says entrepreneur Johnny Stine

Rabbit antibodies have 1,000 times higher “affinity” than mice (they bind with their target on cells much more tightly and for longer). For the biotech business, that means rabbit-generated antibodies can be given in fewer shots, and at much lower doses, saving a bundle on manufacturing costs. And here’s the part that Stine says “blows people away.” With rabbits, he has developed a way to yield hundreds of antibody drug candidates in less than a month. By comparison, it can take several months for mouse methods to yield a single drug candidate, he says. He calls it BLAST (B-Lymphoblast Activation and Selection Technology).

2008-07-23 |

Pharming net loss widens in H1, upbeat on key drug Rhucin

Dutch biotechnology firm Pharming said on Friday its net loss widened by more than analysts forecast in the first half of the year, but it reiterated positive results for its key Rhucin drug. Pharming reported a first-year net loss of 15.2 million euros ($24.1 million), up from 11.3 million a year ago, on revenues of just 200,000 euros compared to 400,000 euros a year ago. It cash position was 38.6 million euros at June 30.

2008-06-26 |

Pharming upbeat on key drug Rhucin prospects

Dutch biotechnology firm Pharming is confident it can convince European authorities of the efficacy of its key Rhucin drug with new tests and get it approved, a senior company executive said on Tuesday. In March, the European Medicines Agency denied approval for drug, which is produced from therapeutic proteins in the milk of genetically modified rabbits, saying it wanted more test results of repeated treatments. Pharming expects to talk to the European authorities later this year about a new application for approval for the drug, which treats hereditary angioedema.

2008-03-28 |

Dutch company Pharming says to receive negative opinion on Rhucin

Dutch biotechnology firm Pharming (PHAR.AS: Quote, Profile, Research) said on Thursday it expected a negative opinion from the European Medicines Agency on the marketing authorization application for its key drug Rhucin. ”Based on this development, the company intends to refile its marketing application for Rhucin with additional data and request expedited EU regulatory review,” Pharming said in a statement.

2007-09-06 |

Pharming lining up U.S. deal for key drug launch

Dutch biotechnology firm Pharming is actively talking to potential U.S. partners for its key drug Rhucin and expects a licensing deal to include an upfront payment, its commercial head said on Thursday. The drug, which is purified from the milk of transgenic rabbits, is intended to treat acute attacks of hereditary angioedema (HAE) and would be the second medicine from a genetically engineered animal to get to market. Chief Commercial Officer Rein Strijker said it could win a green light from experts at the European Medicines Agency in November or December, clearing the way for a first-half 2008 EU launch, with the United States following slightly later.

2007-08-30 |

Pharming rises most in four years after test results

Pharming NV rose the most in four years in Amsterdam trading after the unprofitable Dutch biotechnology company’s treatment for a painful and sometimes fatal disease worked in a clinical study. No patients had a flare up of hereditary angioedema, a tissue swelling, during a late-stage test in the study of the medicine, called Rhucin, the Leiden, Netherlands-based company said today in a statement by Hugin newswire.

2007-07-18 |

Milking transgenic rabbits gets approval in the Netherlands

A drug developed from the milk of transgenic animals is one step closer to being the second such drug on the market following a European thumbs up of its facilities, marking a significant move in the controversial drug development technology. Dutch biotech company Pharming announced it complied with the standards of Good Manufacturing Practices (GMP) following inspections by the European Medicines Evaluation Agency (EMEA) of five facilities used in the manufacturing of Rhucin, a therapeutic protein produced in transgenic rabbits.

2007-02-23 |

Pharming 2006 net loss widens on partnership reserve

Pharming Group NV, a biotechnology company that uses milk from genetically modified rabbits to make its most-advanced experimental drug, said its full-year loss widened on money put aside for future payments to a partner.

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