Shire Plc said that it has received approval from the US Food and Drug Administration to market its treatment for children and adolescents with attention-deficit, hyperactivity disorder (ADHD), strengthening its franchise in this area.
Algeta ASA is to receive $61 million upfront from Bayer Schering Pharma AG in a deal worth up to $800 million to develop and commercialise a radiopharmaceutical for bone metastases in patients with hormone-refractory prostate cancer.
The Roche Group said its therapeutic antibody, MabThera ( rituximab), has been approved in Europe for the treatment of relapsed or refractory chronic lymphocytic leukaemia. The drug is already authorised for three other treatments.
Pharming Group NV said that it has submitted a new marketing authorisation application for its recombinant human C1 inhibitor, Rhucin, to the European Medicines Agency which addresses the agency’s concerns about the size of its database.
Affitech A/S has recruited two senior biopharmaceutical company executives from outside the company to lead its management team following the company’s merger in May 2009 with Pharmexa A/S.
The Food and Drug Administration has asked SkyePharma Plc to provide more clinical data for its asthma treatment, Flutiform, thereby extending its review of the Flutiform new drug application (NDA) into 2011, the UK company said.
Innate Pharma SA said that it has sufficient cash to finance its clinical programmes into 2011 even as it steps up development of its candidate products for cancer. A Phase 2a trial of a monoclonal antibody for multiple myeloma is set to start soon.
The Norwegian government has awarded Clavis Pharma ASA up to $1.1 million to accelerate its early clinical-stage treatment for pancreatic cancer, intravenous CP-4126. The grant was made by Innovation Norway, a state-owned company.
Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, has been reported to show an improvement in lung function in patients with chronic obstructive pulmonary disease in four Phase 3 trials published in The Lancet. The drug is produced by Nycomed.
Ablynx NV nearly doubled its revenues to €11.9 million in the first half of 2009 following milestone payments from its research collaborators, Novartis, Wyeth, Boehringer Ingelheim and Merck Serono.