United States
The motive for the shocking murder of Brian Thompson in New York City was still unknown Wednesday afternoon.
The December calendar features nearly 20 user fee goal dates, from Novo Nordisk’s Alhemo to Lexicon’s Zynquista.
The manufacturer dispute with hospitals and US agency tasked with overseeing the outpatient drug discount program is entering a new phase.
Scant evidence has emerged proving that carving out retail pharmacy benefit management from Medicaid managed care organization contracts helps limit costs.
The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.
The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.
The US FDA seeks to better understand and predict insertional mutagenesis in gene therapies like bluebird bio's Skysona, which use integrating viral vectors, but a workshop on integration site analysis highlighted the approach's complexity and limitations.
The pharma industry arguably suffered none of the possible downside risks during the first Trump Administration, but its relationship with Biden could not have been much worse. And while sponsors may hope a Trump return could improve their fortunes, having Robert F. Kennedy Jr. supervising the FDA is likely not the prescription they prefer.
The expected nominee for FDA commissioner has not been very kind to the agency in his public statements and President-elect Donald Trump appears to be urging him to shake things up.
The company said its financial viability is in jeopardy, along with patient access to Lyfgenia, if US FDA Commissioner Robert Califf does not reverse the denial of a rare pediatric disease priority review voucher.
US President-elect Donald Trump’s second term is seen in general as “bad news” for Asia, especially China, by some analysts. But the outlook for India pharma appears upbeat, says a cross-section of experts.
Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.
The agency will focus less on new capabilities and more on meeting explicit mandates for the Sentinel active surveillance system, in part due to budgetary realities.
Proposed rule on GLP-1s sets up an expensive benefit that would need to be implemented (or rejected) by the incoming Trump administration. Move suggests the next round of drugs subject to Medicare price-setting will include Novo’s semaglutide – and could be announced by the Biden team before they leave.
Martin Makary’s ties to a compounder and telehealth company offering compounded GLP-1s may concern the drug industry and raise questions about his fundamental beliefs in the FDA’s role regulating drug manufacturing.
Numerous staff positions at the US FDA could be the target of incoming administration efforts to remake the federal bureaucracy.
The FDA Commissioner wants sponsors to incorporate diversity into their development programs prior to Phase III.
The US FDA’s Peter Marks told the Jefferies meeting that scientific leadership will be protected and that the agency wants to do more to help the sector accelerate innovation.
The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.
Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.