Bristol-Backed Program May Spur Immunotherapy Use In Community Setting

Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.

US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.