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Takeda Pharmaceutical announced that its European R&D subsidiary has submitted a marketing authorization application to the European Medicines Agency for the company's insomnia medication, ramelteon.
Siga Technologies announced that a toddler who contracted eczema vaccinatum has been treated with ST-246, the company's lead smallpox drug candidate, pursuant to an emergency investigational new drug application granted by the FDA, and the child is now improving.
Nektar Therapeutics has initiated a Phase I clinical trial program to evaluate the safety, tolerability and pharmacokinetics of NKTR-102 (PEG-irinotecan), an innovative new oncology therapy with the potential to treat patients with refractory solid tumors, the company announced.
Avexa has announced highly successful results from its Phase IIb trial for apricitabine (ATC), the company's novel nucleoside reverse transcriptase inhibitor (NRTI) being developed for the treatment of HIV infection in patients with drug-resistant HIV.
Napo Pharmaceuticals has received independent review board (IRB) approval to begin the pivotal, Phase III ADVENT study of crofelemer for diarrhea in people living with HIV/AIDS, the company announced.
MGI Pharma announced that a randomized, double-blind, multicenter, pivotal Phase III trial of Aquavan for sedation of patients undergoing bronchoscopy successfully met its primary endpoint of sedation success as well as all secondary endpoints.
Corcept Therapeutics announced that Study 06, the last of three Phase III trials evaluating Corlux for treating the psychotic features of psychotic major depression, did not achieve statistical significance with respect to its primary endpoint.
The FDA has granted tentative approval to two generic combination HIV treatments made by Strides Acrolab under the expedited review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).