Pharming Group NV said that the results of its Phase 3 North American trial of the recombinant human protein, Rhucin, were positive enabling it to proceed with regulatory filings in both the US and Europe.
Novartis Vaccines and Diagnostics, a unit of Novartis, has told the European Medicines Agency (EMEA) that it is withdrawing its marketing authorisation application for Aflunov, a pre-pandemic vaccine.
SYGNIS Pharma AG is acquiring the closely-held US biopharmaceutical company, Amnestix Inc, for €4 million, paying a combination of cash and shares.
Genmab A/S, which develops therapies based on fully human antibodies, expects to report revenue of 1 billion Danish Krone (DKK) in 2008. However, it is projecting an operating loss of DKK 900 to 1,000 million and a net loss in the range of DKK 800 to 900 million.
Jerini AG expects to launch its treatment for acute attacks of hereditary angioedema (HAE), Icatibant, in Europe in the third quarter of 2008 following a positive opinion from the main scientific committee of the European Medicine Agency in April. The company expects to receive a marketing authorisation from the European Commission in late June or early July, a spokeswoman told MedNous.
Ablynx NV of Ghent, Belgium, which is developing a new class of antibody-derived therapeutic proteins called Nanobodies, said that revenues for the first quarter of 2008 were €3.3 million, up by 53% compared with €2.1 million a year earlier.
Protherics Plc, which focuses on specialist products for critical care and cancer, reported trading revenues of £23.5 million for the year ended 31 March 2008, up by 27% from the previous period.
There has been a gradual, but fundamental shift in the way regulatory agencies interact with the pharmaceutical industry, so that it is now commonplace for companies to meet with regulators before drug development gets into full swing.
Ipsen SA has announced three separate deals to acquire assets in the US relating to the fields of endocrinology, neuromuscular disorders and haematology.
Novartis has acquired rights to a new broad-spectrum antibiotic currently in Phase 2 development in connection with its takeover of the product’s owner, Protez Pharmaceuticals of Malvern, Pennsylvania.