Four new medicinal products and four biosimilar products are being recommended for licensing in Europe by the European Medicines Agency (EMEA). The agency’s recommendations will be referred to the European Commission which has responsibility for issuing marketing authorisations.
The European Medicines Agency has recommended approval of a ‘pre-pandemic’ vaccine that will generate an immune response to the ‘bird flu’ virus, H5N1 in case it evolves into a pandemic human influenza.
GPC Biotech AG has announced a third round of job cuts and a reshaping of its development activity in order to make its cash reserves cover three years of operating expenses.
Actelion Pharmaceuticals Ltd has decided to withdraw its application to the European Medicines Agency (EMEA) for an extended indication for its orphan product, Zavesca (miglustat).
Vernalis Plc is reorganising its management, more than halving its workforce, closing a clinical development site in Canada and divesting one of its marketed products in order to conserve cash in the wake of a regulatory setback for its migraine product, Frova (frovatriptan succinate).
Directors of the Medical Marketing International Group (MMI) have removed its chairman, David W. Best, in what was described as a “disagreement regarding the future leadership of the business.”
Shire Plc, the British speciality pharmaceutical company, reported 46% rise in fourth quarter 2007 revenues, bringing the overall gain in turnover for the year to 36%.
Ardana Plc is restructuring its business to reduce its cash commitments while looking to sell or merge the company, according to company announcements on 19 February 2008.
Pharmexa A/S, a Danish company that is developing immunotherapy vaccines for treatment of serious cancers, is reducing its development programmes, cutting staff numbers by 20% and moving to smaller premises in an effort to conserve cash while it looks for a buyer for all or part of its assets.
Pharming Group NV of the Netherlands said its cash position improved in 2007 following a successful convertible bond issue in October which raised €70 million. Cash on 31 December was €65.3 million compared with €31.3 million a year earlier.