Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that three new scientific abstracts will be presented as part of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting including a poster presented by Friends of Cancer Research (FoCR) featuring genomic data contributed by Biodesix…
Recruiting cancer patients for clinical trials is challenging due to lack of awareness, geographical and socioeconomic limitations, and strict eligibility criteria. As it relates to eligibility criteria, one of the most commonly used is the Eastern Cooperative Oncology Group (ECOG) performance status (PS), which was developed and published in 1982 by the Eastern Cooperative Oncology…
Today’s critical shortage of cisplatin and carboplatin occurred because manufacturers failed to invest in enhancing production capacity and grew excessively dependent upon a single supplier of raw materials, Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, said to The Cancer Letter. In a wide-ranging…
NEW YORK–(BUSINESS WIRE)–Flatiron Health today announced that the company and its collaborators will present a total of 12 abstracts accepted for poster discussion, presentation, and online publication at this year’s American Society of Clinical Oncology (ASCO) Annual meeting, to be held in Chicago this June. “As demonstrated by our presence at ASCO this year, Flatiron…
Regulators, industry players, and academic researchers see a need to streamline and better define the regulatory path for cell and gene therapies as they traverse from the lab to the commercial market. To date, there’s been little consensus on what a streamlined regulatory pathway might look like for cell and gene therapies, but in two…
The context: Marks on tour to discuss CGT Products CBER Director Peter Marks was among several FDA staffers who made the rounds at conferences last week, appearing on several panels to discuss accelerated approval, the promise of gene therapies, and the general operations of CBER’s new Office of Therapeutic Products (OTP) as it continues to work…
Diagnostic regulatory reform: A (very compressed) background In Vitro Diagnostics (IVDs) are regulated as medical devices in the U.S. The FDA’s medical device framework was established under the Medical Device Amendments of 1976, which define a medical device as “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, diagnose disease in…
Today, President Biden announced his intention to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health. Bertagnolli – who currently serves as Director of the National Cancer Institute – is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader. In a statement, President Biden said, “Dr. Bertagnolli has spent her career pioneering…
The US Centers for Medicare & Medicaid Services is reassuring oncology patient advocates that it is not changing its historic approach to coverage of medicines approved via the Accelerated Approval pathway. CMS is facing bipartisan criticism for its restrictive coverage policy for beta amyloid targeted therapies to treat Alzheimer’s, which deems drugs approved via the…
President Biden nominated Monica Bertagnolli to head the National Institutes of Health and steer the federal government’s pursuit of cutting-edge medical research. The Wall Street Journal in April first reported the White House’s pick. Monday’s nomination would end a 17-month search to find a scientist to head an agency, with a $47 billion yearly budget, that plays an…
