FDA accelerates review of Shire product
The US Food and Drug Administration has accelerated its review of a new product for Fabry disease produced by Shire Plc as supply shortages of the only currently marketed treatment for the disease continue.
News
Addex plans Phase 2b trial of Parkinson’s treatment
Following the failure of its lead compound for migraine, Addex Pharmaceuticals Ltd is refocusing its clinical development and partnering efforts on a candidate treatment for patients with Parkinson’s disease.
Shire predicts growth in sales and earnings in 2010
Shire Plc, the British specialty pharma company, produced 2009 revenues of $3 billion, little changed from the previous year. This was an accomplishment because sales of its best-selling drug fell 43% after it lost its US patent protection in the 2009 first quarter.
CellCentric out-licenses epigenetic discovery programme
In a boost for the emerging field of epigenetics, privately-owned CellCentric Ltd of Cambridge, UK has negotiated access to one of its cancer discovery programmes to Takeda Pharmaceutical Company Ltd. The deal is valued at about $200 million.
ReNeuron raises £4.7 million in share placement
The ReNeuron Group Plc has raised £4.7 million, before expenses, from a private share placement with existing and new institutional investors in order to finance its ground-breaking, first-in-man study of a stem cell therapy for stroke.
FDA gives Novartis MS drug priority review status
The US Food and Drug Administration has given Novartis AG’s investigational drug for multiple sclerosis, fingolimod, priority review status, a speedier regulatory pathway for drugs that promise major advances in treatment.
EMA recommends conditional approval of GSK cancer drug
The European Medicines Agency (EMA) has recommended approval of GlaxoSmithKline’s new angiogenesis inhibitor for renal cell cancer, Votrient (pazopanib), conditional on further proof of the drug’s effectiveness.
EMA rejects antibiotic for breaches of GCP
The European Medicines Agency has taken the unusual step of rejecting a marketing authorisation application for an antibiotic because the human studies supporting the drug did not comply with good clinical practice.
FDA approves MabThera for leukaemia
The US Food and Drug Administration has approved MabThera ( rituximab), plus chemotherapy, for people with previously untreated or previously treated CD20-positive chronic lymphocytic leukaemia, the Roche group announced.
Ablynx receives €1.2 million grant for autoimmune therapy
Ablynx NV has been awarded €1.2 million by an agency of the regional government of Flanders in Belgium to accelerate development of a preclinical antibody therapeutic for autoimmune and inflammatory diseases.