FDA opens door to multiarm, multicompany clinical trials
December 19, 2017
By Neozene

The FDA has outlined how developers of drugs targeting rare pediatric diseases can streamline their clinical development programs by collaborating. Officials want drug developers to consider multicompany clinical trials to test multiple candidates in single trials, thereby cutting the number of patients who need to receive placebos. Using Gaucher disease as an example, the FDA’s draft guidance (PDF) shows how companies can team up and run multidrug clinical trials. These studies would enable multiple experimental candidates to be compared against a single control group, increasing the proportion of patients in active arms.

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Takeda pushes U.S.-backed Zika vaccine into the clinic
December 12, 2017
By Neozene

Even after the Biomedical Advanced Research and Development Authority suspended funding to its Sanofi-partnered Zika vaccine project, the agency continued its financial commitment to Takeda’s project. Now, Takeda has advanced its candidate into human testing. The purified, inactivated, alum-adjuvanted vaccine, dubbed TAK-426, contains whole Zika virus. For the phase 1 trial, Takeda aims to enroll 240 flavivirus-naïve healthy adult subjects in Florida, Kansas, New York State and Puerto Rico. No pregnant women will be admitted into the study, according to information posted on clinicaltrials.gov. Investigators plan to examine the safety

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