CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.
CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.
The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access (“compassionate use”) program”, states the release.
The tragedy may become a talking point in the debate surrounding risk companies take on by allowing access to drugs in expanded access programs.
The news serves as an update to an October PharmExec blogpost, from a panel discussion at the Rare Diseases and Orphan Products Breakthrough Summit held by the National Organization for Rare Disease (NORD).
In the post entitled Expanded Access: Myths, Truth and Behavior, PharmExec quoted Kay Holcombe, Senior Vice President, Science Policy at Biotechnology Industry Organization (BIO) who said, “Not all companies are big, small companies are scared, and myths drive behavior.”
The debate at NORD’s summit highlighted Chimerix’s very public exchange surrounding Josh Hardy, an 8-year-old boy and pressure to allow expanded access to anti-viral drug, brincidofovir (CMX001).
Two FDA officials said that they had put to rest the myth that AEs in expanded access had affected the approvability of any product they had seen in their time at FDA.
Thanks to a tipster who commented on CytRx’s announcement.
The Weight-Loss Gold Rush: Legal and Regulatory Implications
July 11th 2024Jim Shehan, chair of the FDA Regulatory practice, Lowenstein Sandler, discusses how the FDA and other regulators likely to respond to the increased public interest and potential off-label use of GLP-1 drugs, what needs to be done for GLP-1s to be covered, advice for investors and financiers considering entering the weight-loss medication market and more.
Healthcare Marketing Strategies for Reaching Diverse Audiences
May 14th 2024Amanda Powers-Han, Chief Marketing Officer, Greater Than One, and Pharmaceutical Executive Editorial Advisory Board member, discusses how improved DE&I in healthcare marketing strategies can not only reach diverse audiences more effectively but also contribute to improved patient care outcomes, challenges faced in crafting culturally sensitive messages, and much more.