Antibiotics (PDF file)
Report from the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR), which said FDA and EMA will discuss using the same clinical trials to support approvals of antibiotics in both territories (see BioCentury Extra, Tuesday, May 13).
Biosimilars (PDF file)
FDA draft guidance on clinical pharmacology data needed to support approval of biosimilars, which said the extent of data requirements for a biosimilar product will depend on the agency's confidence in the level of similarity to the reference product (see BioCentury Extra, Tuesday, May 13).
FDA blog post on an initiative to exchange information with EMA and the European Commission on foreign facility inspections (see BioCentury Extra, Monday, May 12).
FDA and EMA draft joint plan to develop products to treat Gaucher's disease in children (see BioCentury Extra, Wednesday, May 14).
Innovation (PDF file)
The U.S. House of Representative's House Energy and Commerce Committee white paper, which was released through its 21st Century Cures initiative, asking for feedback on proposals put forth by President's Council of Advisors on Science and Technology (PCAST) to help development of innovative treatments.
NIH's National Center for Advancing Translational Sciences (NCATS) funding announcement for its New Therapeutic Uses program, which for the first time included pediatric agents (see BioCentury Extra, Monday, May 12).
— Draft report from an advisory council from the NIH's National Center for Advancing Translational Sciences (NCATS) on ways to formalize and standardize the evaluation processes in the NCATS's Clinical and Translational Science Award (CTSA) program. (PDF file)
— Text of a bill that the U.S. Senate failed to pass which would have extended for two years tax breaks that expired at the end of 2013, including the R&D credit (see BioCentury Extra, Thursday, May 15).
— Zytiga: The U.K.'s NICE draft guidance recommending against the use of Zytiga abiraterone to treat metastatic castration-resistant prostate cancer (CRPC) in chemotherapy-naïve patients; from BTG plc (LSE:BTG) and Johnson & Johnson (NYSE:JNJ) (see BioCentury Extra, Tuesday, May 13).