Access program opened for investigational AIDS drug
Tibotec Pharmaceuticals has announced the opening of an expanded-access program for TMC125, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1.
Tibotec Pharmaceuticals has announced the opening of an expanded-access program for TMC125, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1. The compound is currently in phase III trials and is active against NNRTI-resistant strains of the virus. The program is available to patients with HIV-1 who are at least 18 years old, have a history of virological failure or intolerance to previous regimens, and have received treatment from each of the three major oral classes of drugs (nucleoside reverse transcriptase inhibitor, NNRTIs, and protease inhibitors), with at least two being protease inhibitor-based regimens. For more information about the program, call 1-(866) 889-2074.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
