In The News
AACR – RACE Act Increased the Number of Cancer Drugs with Required Studies for Use in Pediatric Patients
NEW ORLEANS – In its first year of implementation, the RACE Act has resulted in increased requirements for more recently approved cancer drugs to be
GlobeNewswire – Bionano Genomics Announces Release of Version 6.2 of its NxClinical Software with Significant New Capabilities for Cancer Research Applications Including HRD Analysis
SAN DIEGO, April 07, 2022 (GLOBE NEWSWIRE) — Bionano Genomics, Inc. (BNGO), pioneer of optical genome mapping (OGM) solutions on the Saphyr® system and provider of
Oncology Times – Biomarker-Driven Development of Diagnostics for Rare Diseases
Biomarker-driven cancer care relies on precision companion diagnostics co-developed with targeted therapies in clinical trials. A one-drug/one-test strategy has been the norm in such co-development.
BioSpace – Accelerated Approval Integrity Act Could Remove Therapies Before They Prove Merit
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the Food and Drug Administration‘s accelerated approval pathway. The bill, however, fails to adequately
The Washington Post – National Cancer Institute Director Sharpless stepping down
Norman “Ned” Sharpless, the director of the National Cancer Institute who had a short stint leading the Food and Drug Administration, announced Monday that he is stepping down
Bloomberg Law – National Cancer Institute Director Sharpless Steps Down (1)
Ned Sharpless, one of the last presidential appointees from the Trump administration to be held over by President Joe Biden’s White House, will step down
Dr. Ned Sharpless Stepping Down as National Cancer Institute Director
Friends of Cancer Research (Friends) would like to thank Dr. Ned Sharpless for his tireless public service and scientific leadership as Director of the National
Regulatory Focus – FDA says IT modernization came at right time for COVID
While the US Food and Drug Administration (FDA) began the process of modernizing its IT systems before the COVID-19 pandemic, the crisis accelerated much of
Regulatory Focus – White paper: RWD can support multi-cancer early detection screening test submissions
Real-world data (RWD) potentially could be used to supplement data from clinical screening studies to support regulatory decision making for multi-cancer early detection (MCED) screening
Stat News – Lawmakers and a Pelosi aide turn lobbyist to push for new health agency’s independence
WASHINGTON — Health secretary Xavier Becerra is suddenly the target of a frenzied lobbying campaign aimed at ensuring the independence of ARPA-H, the new high-stakes
