In The News

June 5, 2023

News Medical – Fred Hutch experts highlight research on cancer treatment advances, survivorship and precision oncology at ASCO

At the 2023 American Society for Clinical Oncology Annual Meeting—to be held June 2-6 in Chicago, Illinois—Fred Hutchinson Cancer Center experts will present research spanning survivorship, advances in treatments and clinical trials, how access to cancer care affects outcomes, integrative medicine and more. Featured Fred Hutch presentations and poster sessions are listed below; for a…

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June 1, 2023

Business Wire – Biodesix Announces Three Abstracts to Be Presented at ASCO 2023 Annual Meeting

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…

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May 31, 2023

Applied Clinical Trials Online – Rethinking ECOG Scores to Improve Patient Access and Clinical Trials Eligibility

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…

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May 30, 2023

The Cancer Letter – Richard Pazdur discusses root causes of cisplatin and carboplatin shortage and what can be done to alleviate it

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…

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May 25, 2023

Business Wire – Flatiron Health Announces Research to be Presented at American Society of Clinical Oncology 2023 Annual Meeting

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…

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May 24, 2023

Precision Medicine Online – FDA, Industry Taking Steps to Streamline Cell Therapy Regulation, Though Uncertainty Remains

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…

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May 23, 2023

AgencyIQ – CBER’s Peter Marks on advancing gene therapy, using AI, pushing accelerated approval and bespoke platforms

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…

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May 19, 2023

AgencyIQ – What’s next for diagnostics reform in the US?

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…

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May 16, 2023

The White House – WHAT THEY ARE SAYING: Leading Doctors, Researchers, Advocates, and More Applaud President Biden’s Nomination of Dr. Monica Bertagnolli as NIH Director

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…

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May 16, 2023

Pink Sheet – US Medicare Agency Clarifies View Of Accelerated Approval

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…

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