Swiss drug maker Roche Holding AG said that the Food and Drug Administration has delayed even further the approval of the potential blockbuster rheumatoid arthritis drug Actemra by asking for more non-clinical data concerning fertility issues. Actemra is an anti-interleukin-6 receptor antibody.

The Food and Drug Administration delayed the approval of AstraZeneca’s Motavizumab, a drug to treat respiratory syncytial virus (RSV) and a successor Synagis. Further details.

The Food and Drug Administration (FDA) announced it has extended the review period for Eli Lilly & Co and Daiichi Sankyo´s new blood-thinning drug Effient (prasugrel), delaying a decision on approval by another three months, one of the possibilities within the announced deadline review date of June 26th. Further details.

The FDA has extended the priority review period for Glaxo’s and Ligand Pharmaceuticals’ Promacta for short-term treatment of chronic ITP for another 90 days. If approved, the compound would be the first oral platelet growth factor therapy for this condition

Merck & Co. provided an update on the U.S. regulatory status of its experimental drugs MK-0524A and MK-0524B for the treatment of primary hypercholesterolemia or mixed dyslipidemia at a meeting with market analysts, saying it may have to wait until 2013 to complete the data required by the Food and Drug Administration (FDA).