Swedish Orphan Biovitrum (Sobi) has told analysts that its recombinant clotting factor product for haemophilia B achieved positive results in a Phase 3 trial, paving the way for a regulatory filing in the US in the first half of 2013.
Noxxon Pharma AG of Germany has started a Phase 2a study of an oligonucleotide-based drug in patients with multiple myeloma, a disease that accounts for about 1% of all cancers. The 28-patient, multi-center study is being conducted in Europe.
MorphoSys AG said its candidate antibody for rheumatoid arthritis targeting granulocyte macrophage-colony stimulating factor (GM-CSF) has shown an unusually high efficacy score at four weeks in a Phase 1b/2a clinical study.
In what is being described as the largest initiative of its kind, 10 large pharmaceutical companies have announced the setting up a non-profit organisation through which they will collaborate to accelerate and improve clinical research.
Venture-capital backed Immune Targeting Systems Ltd has reported the results of its first clinical test of a new synthetic peptide vaccine for influenza A. It has also announced changes in top management ahead of a new funding round.
Eli Lilly and Company said that a Phase 3 trial (Pointbreak) of a combination treatment for patients with nonsquamous non-small cell lung cancer has failed to meet its primary endpoint of improved overall survival.
On the heels of a successful share placement in July, Oxford BioMedica Plc is moving its gene therapy and cancer vaccine programmes ahead with a near-term focus on completing the dosing of patients in a Phase 1 study of a gene therapy for ‘wet’ age-related macular degeneration (AMD).
Eli Lilly and Company has announced a decision to stop Phase 3 development of pomaglumetad methionil for schizophrenia after a futility analysis showed that the second of two studies was unlikely to reach its primary endpoint.
Eli Lilly and Company is to seek advice from regulators about the possible next step for its investigative Alzheimer’s treatment, solanezumab, following the failure of two Phase 3 trials in patients with mild-to-moderate forms of the disease.
Mologen AG of Germany is expediting discussions with potential pharmaceutical company partners with a view towards starting a Phase 3 study of its lead product for colorectal cancer next year. The product, MGN1703, is a toll-like receptor 9 agonist.