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8 September 2019 Tablets & Capsules will assess what patients did with their unused opioids. Briefly noted… The FDA approved Turalio (pex- idartinib) to treat adult patients with symptomatic tenosynovial giant cell tumors that are associated with severe morbidity or functional lim- itations and have not been respon- sive to improvement with surgery. It is manufactured by Daiichi Sankyo, Basking Ridge, NJ. T h e a g e n c y a l s o a p p r o v e d Nubeqa (darolutamide) an andro- gen receptor inhibitor that treats patients with non-metastatic cas- tration-resistant prostate cancer. It is manufactured by Bayer, Leverku- sen, Germany. Janssen Pharmaceutical, Titus- ville, NJ, a pharmaceutical subsidiary of Johnson & Johnson, announced that the FDA approved its Sir- turo (bedaquiline) tablets as part of a combination therapy to treat pedi- atric patients with pulmonary multi- drug-resistant tuberculosis. opment. The program is scheduled to start in Fall 2020. FDA awards Yale, Mayo Clinic $5.3 million opioid research grant S I LV E R S P R I N G , M D — T h e FDA awarded Yale University, New Haven, Connecticut, and Mayo Clinic, Rochester, MN, a grant for up to $5.3 million over 2 years to study patients' experiences with pain and use of opioids prescribed for acute pain. The project is part of the Cen- ter of Excellence in Regulatory Sci- ence and Innovation (CERSI)—a joint effort between Yale, Mayo Clinic, and the FDA—and will be conducted in collaboration with Regional Health of Rapid City, SD, and the Univer- sity of Alabama at Birmingham. The Yale-Mayo Clinic CERSI will enroll 1,200 patients who have been pre- scribed short-acting opioids for pain after receiving care and will follow the patients for 180 days, collecting information on pain control and opi- oid use through survey questionnaires. At the end of follow-up, the CERSI isation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and provides recommenda- tions for the appropriate use of a selective approach to safety data col- lection in some late-stage, pre-, or postmarketing studies of drugs. The agency intends for the draft guidance to advance clinical research ques- tions through clinical investigations that collect relevant patient data and enable an adequate benefit-risk assessment of the drug, while reduc- ing patient burden. VCU launches first pharmaceutical engineering doctoral program R I C H M O N D , VA — Vi r g i n i a Commonwealth University (VCU) has created the first pharmaceutical engineering PhD program in the US. The doctoral program is a collabora- tion between VCU's School of Phar- macy and College of Engineering and will focus on research as well as train- ing students in continuous manufac- turing, drug-containing nanomaterials, and other areas of drug product devel- Compacta II MiniPress Piccola Touch Adamus One Piccola Bilayer