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Category: In the News

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…

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…

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…

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…

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…

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…

The Wall Street Journal – Biden Nominates Monica Bertagnolli to Run National Institutes of Health

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…

Endpoints News – President Biden nominates NCI director Monica Bertagnolli to lead NIH

President Joe Biden announced Monday that he intends to nominate Monica Bertagnolli, who’s currently leading the National Cancer Institute, as the head of the National Institutes of Health. If confirmed by the Senate, Bertagnolli would be the second woman to serve as NIH director since Bernadine Healy in the early 1990s under President George H.W.…

Politico Pro – Biden chooses cancer surgeon to lead NIH

Monica Bertagnolli, the Boston cancer surgeon President Biden picked on Monday to lead the National Institutes of Health, faces a daunting job at the nation’s premier health research agency: restoring faith in science. Before she gets that chance, she will have to face Republican senators who are deeply skeptical of the NIH following its politicization…

Bloomberg – Biden to Nominate Cancer Chief Monica Bertagnolli to Lead US NIH

President Joe Biden will nominate National Cancer Institute head Monica Bertagnolli to lead the full National Institutes of Health, the White House said Monday. If confirmed, Bertagnolli would be only the second woman to lead the science agency as permanent director since the position was created in 1887. Bloomberg News earlier reported that Biden would announce the nomination…