Category: In the News

Stakeholders prepare for the U.S. Food and Drug Administration’s (“FDA”) rulemaking effort to “make explicit” that laboratory developed tests (“LDTs”) are devices subject to the agency’s oversight, reigniting outstanding questions of jurisdiction and authority. The Office of Management and Budget’s Office of Information and Regulatory Affairs (“OIRA”) recently received a proposed rulemaking from FDA to regulate LDTs…

GODFREY, Ill., Aug. 21, 2023 /PRNewswire/ — Theresa’s Research Foundation is excited to announce a new White Paper titled “Continuing to Improve the Odds Together: Next Steps for Engaging Researchers and Advocates.” An appreciation for the value of including the patient advocate voice in cancer research has increased in recent years, however, research scientists and patient advocates are often uncertain…

An oncology drug “strategic reserve” could be a long-term solution to chronic shortages of critical cancer medicines in the US, FDA Oncology Center of Excellence Director Richard Pazdur suggested during a Friends of Cancer Research workshop last month. While carefully noting that he cannot advocate for legislative changes, Pazdur described the stockpile as an idea…

Lobbyists from both sides of a debate over whether laboratory developed tests should be regulated as medical devices are making a last-minute push to influence an FDA proposal under review at the White House. Laboratory, diagnostic manufacturer and pathologist trade lobbies are ramping up efforts to influence the agency proposal that is likely to explicitly…

The House Energy and Commerce Committee Republican leadership is asking the US Food and Drug Administration for a wealth of information about its approach to inspections in India and China coming out of the COVID shutdown period. A July 18 letter to Commissioner Robert Califf focuses squarely on a key vulnerability for the agency: how to assure…

Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company that aims to develop the world’s most potent vaccines, today announced that the company has joined the ctMoniTR Project, a collaborative research initiative providing foundational evidence to inform future use of change in circulating tumor DNA (ctDNA) as an early indicator of long-term clinical benefit from therapeutics…

The Centers for Medicare and Medicaid Services has established a precedent regarding Medicare Part B coverage for accelerated approvals with its decision triggered by Biogen, Inc.’s Aduhelm to only cover that class of Alzheimer’s treatments when patients are enrolled in a clinical trial, according to former US Food and Drug Administration Commissioner Scott Gottlieb. But the…

The evolution of clinical trial enrollment criteria to more accurately represent real-world lung cancer populations will be contingent on cooperation and innovation from members of the entire oncology community, including researchers, community oncologists, and trial sponsors, according to Edward S. Kim, MD, MBA. “If you’re investing [resources] and putting trials in the community, let’s make…

With work ongoing in the oncology community to develop the evidence needed to support circulating tumor DNA as a regulatory efficacy endpoint, one US Food and Drug Administration official is making a plea for standardization. Developing the evidence needed to support use of a novel endpoint is a “heavy lift” requiring many stakeholders and pooling…

A recent workshop summed up the state of play for circulating tumor DNA. Although evidence is building of its utility as a biomarker in many oncology settings, its prognostic value has yet to be proven, limiting any current utility as an endpoint for regulatory use for cancer therapeutics. Oncology endpoints: The growing pains of an…