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The FDA has approved an sNDA for Novartis’ Promacta for the treatment of children six years and older with the chronic immune thrombocytopenia who have had a poor response to corticosteroids, immunoglobulins or spleen removal. Read More
Sponsors of new drugs to treat cardiovascular and metabolic diseases should use a composite of all major cardiovascular events as the primary endpoint in studies to establish CV risk, the European Medicines Agency says. Read More
An FDA associate commissioner and five associates are pushing for greater transparency around complete response letters issued to drugmakers when marketing applications are denied. Read More
A citizens advocacy group is accusing the FDA of wrongly expanding the indication of Vanda Pharmaceuticals’ sleep disorder drug Hetlioz by labeling it for use in sighted people. Read More
The FDA wants drugmakers to assess the risks of active pharmaceutical ingredients taken by men on the development of embryos and fetuses of their female partners. Read More
Because cellular and gene therapy products can have more severe effects than other types of drug products, potentially leading to organ failure, tumors or death, sponsors should include these as primary safety objectives when designing early-phase clinical trials, the FDA says. Read More
Drugmakers under consent decrees with the FDA may be able to deduct some payments made as part of their settlement with the agency when they file their tax returns, according to an informal opinion by the Internal Revenue Service’s chief counsel. Read More
Merck and Samsung Bioepis said Wednesday that their biosimilars for Enbrel and Remicade both met primary endpoints in pivotal Phase 3 clinical trials, putting them on the path to filing regulatory submissions. Read More
For the second time in two days, the FDA has recommended approval of a PCSK9 inhibitor as an effective and relatively safe means of lowering bad LDL cholesterol. Read More
The Goldwater Institute is suing the FDA after it denied the group’s Freedom of Information Act request for information on the process the agency used in allowing two Americans to be treated with an investigational anti-Ebola drug. Read More