In The News

December 9, 2024

Pink Sheet — US FDA Wants More ‘Rigor’ In Assessing Survival As An Oncology Safety Endpoint

Clinical trial simulations and predictive modeling will be important for improving regulatory decisions about oncology drugs showing strong efficacy on early endpoints but with uncertain overall survival benefits. Panelists at the recent Friends of Cancer Research Annual Meeting discussed a new white paper on the use of interim overall survival data in oncology trials. The FOCR project…

December 6, 2024

Stat+ — Trump’s win puts future oversight of lab-made tests in jeopardy

WASHINGTON — The Food and Drug Administration has always believed it has the power to regulate tests made in labs. But it was only under President Biden that it began actively exercising that authority, releasing a policy in April telling labs they have four years to comply with regulatory requirements. It was a move that sought to…

December 5, 2024

Bloomberg Government — Health Care Brief: FDA Chief to Talk Diabetes, Obesity Epidemics at Senate Today

Rob Califf will likely make his final appearance as FDA commissioner on Capitol Hill today to talk about the nation’s obesity and diabetes epidemics—issues Robert F. Kennedy Jr. said he’ll prioritize if he’s confirmed as Donald Trump’s health secretary. Sen. Bernie Sanders (I-Vt.), chair of the Senate Health, Education, Labor, and Pensions Committee, convened today’s hearing…

November 23, 2024

Fierce Pharma — Trump selects surgeon and author Martin Makary for FDA commissioner post

President-elect Donald Trump has put forward a formal pick for the top spot at the U.S. Food and Drug Administration. As recently projected, Trump has named Johns Hopkins surgeon and author Martin Makary, M.D., as his choice for FDA commissioner during his upcoming term. In a statement Friday, Trump said the FDA “has lost the trust…

November 22, 2024

The Washington Post — Trump picks Marty Makary to lead FDA, Dave Weldon to run CDC

President-elect Donald Trump on Friday night named three doctors to oversee the nation’s vaccine supply, disease response and other responsibilities central to America’s public health, plucking physicians who bring a mix of conservative credentials and Fox News appearances. The flurry of announcements included one long-expected decision: Trump picked Marty Makary, a Johns Hopkins surgeon, to lead…

November 21, 2024

Fierce Pharma — Biopharma status quo ‘likely to persist’ under Trump 2.0, though changes to IRA, FTC and more could be on the way: analyst

As the biopharma industry braces for a second term under President-elect Donald Trump, speculation is swirling around the returning administration’s effect on issues like Medicaid spending, the future of drug price negotiations and, of course, the great Robert F. Kennedy Jr. “wildcard.” Still, given Trump’s focus on matters beyond healthcare and a more hands-off approach…

November 20, 2024

Regulatory Focus — Stakeholders seek changes to FDA’s oncology multiregional trial guideline

Stakeholders want the US Food and Drug Administration (FDA) to consider the logistical and legal challenges when researchers conduct trials across different regulatory jurisdictions in its guidance on multiregional clinical trials (MRCTs) for oncology drugs. They also want more clarification on the statistical methods researchers may use, including Bayesian methods. Friends of Cancer Research (FoCR)…

November 14, 2024

AgencyIQ — Friends of Cancer Research annual meeting tackles endpoints and efficiency

At the Nov. 12 Friends of Cancer Research (FOCR) annual meeting, regulators, clinical trialists and industry convened to address ways to boost efficiency in oncology clinical trials and make regulatory processes more efficient. The day was organized around three foundational white papers published by FOCR; AgencyIQ has highlights and takeaways here. The Friends of Cancer…

November 14, 2024

FirstWord PHARMA — Trump taps RFK Jr. for HHS role, rattling vaccine stocks

US President-elect Donald Trump has chosen Robert F. Kennedy Jr., known for his critical stance on vaccines and federal health bodies, as his nominee for Secretary of Health and Human Services (HHS). The news triggered a selloff in vaccine stocks. As the announcement circulated in the final half hour of trading on Thursday, Sanofi saw…

November 14, 2024

AgencyIQ — The Trump Transition: What does Commissioner Robert Califf think about the election’s impact on FDA?

In one of the first appearances since the election of DONALD TRUMP, current FDA Commissioner ROBERT CALIFF weighed in on issues from staffing to final policy priorities at a cancer-focused workshop. AgencyIQ has the highlights. What Califf said at the Friends of Cancer Research annual meeting For now, current FDA Commissioner ROBERT CALIFF will be…

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