United States

Amgen, BMS, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis and Sanofi will reduce prices of some drugs for Medicaid and offer cheaper prices through direct-to-patient platforms, among other concessions, and receive tariff exemptions.

The US FDA’s cell and gene therapy group has “scores” of active INDs using AI, and is eager to see it grow, but challenges remain with employing AI for decision-support tools, including the lack of good quality datasets to train models.

After conducting more than 30 meetings for drugs, biologics and related issues in 2023 and 2024, less than half as many were held in 2025.

The US Centers for Medicare and Medicaid Services argued gender affirming care is not health care to help justify the new proposed rules. The argument could create a new opening for the federal government to go after other pharmaceuticals.

The FDA’s policies on analgesic labeling appear to be limiting the potential for novel non-opioid pain medicines to qualify for separate payments in Medicare after CMS said the indication must be for post-operative use.

The FDA outlined its plans for “Sentinel 3.0,” including a data hub that would speed queries, during PDUFA VIII negotiations as industry questions whether user fee revenue should continue funding the program.

Regulators in the US and Canada are working together to streamline approval timelines for generic drugs through a voluntary information sharing program.

“We are not going back to Pasteur,” Pfizer CEO Albert Bourla said, criticizing the US government’s current anti-vaccine rhetoric.

The ‘day of reckoning’ for the outpatient drug discount program has arrived as annual spending continues its 20%-plus annual growth rate, Drug Channels’ Adam Fein said.

Medical device sponsors can use real-world evidence without submitting identifiable patient-level data under a new guidance that is expected to expand to drugs and biologics.

Limited visibility into the FDA’s use of remote regulatory assessments and the lack of a clearly defined closeout process leave companies uncertain about outcomes and expectations, industry experts say.

CBER will strive to respond to post-meeting clarification requests within three business days rather than the usual 20 calendar days, according to an updated policy reflecting the expansion of a pilot program that began in the drugs center.

Martin Makary’s photo-op and videos promoting the groundbreaking of a new Novartis US-based manufacturing facility create an appearance of favoritism, President George W. Bush’s former chief ethics lawyer told the Pink Sheet.

A Friends of Cancer Research working group believes “seamless” trial designs could be used more frequently for rare cancer drug development, but advanced planning is key.

The FDA previously rejected AstraZeneca’s bid to convert the Factor Xa inhibitor reversal agent from accelerated to regular approval amid concerns about adverse events and the clinical meaningfulness of benefits seen in the confirmatory trial.

As differences emerged between FDA staff and senior political leaders over its COVID-19 safety review, CBER Director Vinay Prasad added an old colleague and critic of US COVID-19 policy to the center.

A Teva official suggested the increasing reliance on analytical characterizations rather than clinical studies to show biosimilarity should warrant user fee structure changes.

Former agency officials who now represent industry worry that a deregulatory bent could be driving the "Simple Reform" plan to merge all medical product and clinical research inspectorates and that the specialist expertise gained in the 2017 "Program Alignment" initiative will be reversed.

“Section viii cannot function as Congress intended,” if a Federal Circuit Court ruling stands, the US solicitor general argued in urging the Supreme Court to review and reverse the closely-watched Hikma Vascepa skinny-label case.

An IQVIA analysis is the first published investigation of the financial impact of 340B rebates on covered entity-owned pharmacies and supports the manufacturers’ position that the rebate model is workable for providers.