Allos reaches SPA contract with FDA for FOLOTYN Stage 3 trial in PTCL Allos Therapeutics.

Allos reaches SPA contract with FDA for FOLOTYN Stage 3 trial in PTCL Allos Therapeutics, Inc. today announced that the Company has reached contract with the U .S. The analysis will seek to enroll newly diagnosed individuals with PTCL who have achieved a response following initial treatment with a CHOP-centered therapy. The SPA provides FDA agreement that the analysis design and planned analysis of this Phase 3 trial adequately address the objectives necessary to support a regulatory submission. ‘We are pleased to have reached agreement with the FDA on the design of this pivotal Phase 3 trial of FOLOTYN as part of the first line treatment of individuals with PTCL,’ said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics.

Michelle Mello’s work is supported by the Greenwall Faculty Scholars Program. ‘Confidentiality Laws and regulations and Secrecy In Medical Analysis: Improving Public Access to Data On Drug Safety,’ Aaron S. Kesselheim, Michelle M. Mello, Wellness Affairs, Volume 26, #2 2.. Allowing greater access to drug safety data might enable researchers to better evaluate risks For years, pharmaceutical companies have sought to restrict public usage of drug safety data collected in medical trials on the basis that it’s proprietary information, arguing that competitors might use that given information in the development of their own items. However, several recent cases of medicines found to have dangerous side effects after arriving at market, like the anti-inflammatory medication rofecoxib , have elevated concerns about basic safety data being treated as confidential.