Two more Phase III studies for the hypoactive sexual desire disorder therapy is the firm’s best financial investment, CEO Simes says, because the revised design is expected to eliminate the greater-than-expected placebo response that derailed the previous studies.
BioSante Pharmaceuticals Inc. is doubling down on its investment on LibiGel, its testosterone gel for hypoactive sexual desire disorder in menopausal women, with a decision to conduct two new Phase III trials in the face of the failure of the last two studies.
The firm believes it can design the trials to minimize the greater-than-expected placebo response that thwarted the statistical significance of...
Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.
The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.
