Tolerx Inc and GlaxoSmithKline Plc announced that a Phase 3 trial of otelixizumab for patients with new-onset Type 1 diabetes did not meet the primary efficacy endpoint of change in C-peptide, a marker of beta cell function, at 12 months.
Sanofi-Aventis SA and its partner, Regeneron Pharmaceuticals Inc, have announced that their Phase 3 trial of the candidate drug, aflibercept, for second-line treatment of non-small cell lung cancer, combined with docetaxel, did not extend overall survival.
The US Food and Drug Administration announced that it has taken action against the Johnson & Johnson subsidiary, McNeil-PPC, for failing to comply with current good manufacturing practice requirements at three sites.
Bavarian Nordic A/S is considering a rights issue to help finance a Phase 3 trial of its therapeutic vaccine for prostate cancer, Prostvac. The Danish company earlier reached an agreement with the FDA on the design and endpoints for a pivotal study.
Evotec AG has announced the establishment of a research collaboration with Harvard University and the Howard Hughes Medical Institute in the US to discover and develop new treatments for diabetes. Financial terms were not disclosed.
The US Food and Drug Administration has announced the approval of Benlysta (belimumab) to treat patients with systemic lupus erythematosus. It is the first new drug to be approved for this disease since 1955. The developers are GSK and Human Genome Sciences.
An advisory panel of the US Food and Drug Administration has recommended approval of Novartis’s indacaterol as the first once-daily, long-term maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease.
Topotarget A/S of Denmark reported revenue of DKK 129 million (€17.3 million) in 2010, up from DKK 44 million a year earlier, boosted by an upfront payment from its co-development partner for its lead cancer drug, belinostat.
UCB SA of Belgium has completed the placement of €300 million in perpetual subordinated bonds as part of an ongoing effort to restructure its balance sheet. The new bonds will qualify as equity, the company said.
The European Court of Justice (ECJ) has struck down a proposal from member states of the European Union to create a new, unified jurisdiction for the litigation of patent disputes saying the proposal is incompatible with the EU treaties.