Genmab plans BLA filing this year
Genmab A/S plans to file a biologic license application (BLA) this year with the US Food and Drug Administration for its lead product, ofatumumab, a fully human monoclonal antibody.
Genmab A/S plans to file a biologic license application (BLA) this year with the US Food and Drug Administration for its lead product, ofatumumab, a fully human monoclonal antibody.
Ablynx NV of Belgium said that discussions with the regulatory authorities about progressing its lead nanobody product, which targets von Willebrand Factor, into Phase 2, could start before the end of 2008.
In a business update, issued on 27 August 2008, Ark Therapeutics Group Plc, the UK specialist healthcare group, reported progress across all of the main areas of its business, including the clinical development of its novel gene-based therapies. Its most advanced therapy, Cerepro (sitimagene ceradenovec), for brain cancer, is ending a Phase 3 trial. On 30 July, Ark announced that the study had reached its primary endpoint.
Belgium’s Galapagos NV has acquired assets in the field of drug discovery from Sareum Holdings Plc which will enable it to quickly identify promising new small molecule drugs. The acquisition, for £553,000, will give Galapagos all of Sareum’s contracts relating to structure-based drug discovery.
Diamyd Medical AB, a Swedish specialist in autoimmune diabetes, said that a gene it is investigating to treat Type 1 diabetes may also be used for advanced Parkinson’s disease and possibly other neurological conditions.
Pharmexa A/S, the Danish therapeutic vaccine developer, said it expects to conclude discussions about a possible merger by the end of 2008. This follows months of restructuring, including paring back clinical development programmes, in order to conserve cash.
Geneart AG, which specialises in synthetic biology, has reported a 43% increase in net sales in the 2008 first half on the back of strong demand for synthetic genes from the research community and biotech companies.
The ProStrakan Group Plc, the Scottish speciality pharmaceutical company, reported a 26% rise in turnover for the six-months ended 30 June 2008 to £26.4 million from £20.9 million a year earlier but its loss widened, partly as the result of an impairment charge.
Ablynx NV of Belgium said that its 20-month-old research agreement with Boehringer Ingelheim (BI) to develop therapies against Alzheimer’s disease has been extended for another year.
SpePharm Holding BV, the umbrella organisation for a Paris-based company that sells specialised drugs to hospitals in Europe, has raised €26 million with a combination of equity financing and the sale of future revenues from a spasticity drug whose European rights it recently acquired.