Pink Sheet
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.
Alternatives to animal testing can replace lengthy, resource-intensive studies for drug developers, helping to lower costs for companies, but a lack of regulatory global alignment can be a barrier to reducing animal testing, an expert says.
Achieving the EU Biotech Act’s clinical trial efficiency goals hinges on deeper collaboration and stronger integration across Europe’s regulatory authorities.
A modified version of the BIOSECURE Act is finally signed into law in the US under cover of the annual defense bill, but views on its likely impact on Chinese biopharma contractors remain mixed and unclear until watchlists are drawn up.
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.
The version of the Critical Medicines Act adopted by a key committee of the European Parliament could mean uncertainty for the manufacturers of orphan drugs, warns industry.
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.
The UK’s roadmap for reducing animal testing is a positive starting point, but greater transparency from the drug regulator and a more detailed workplan from government will be required to make the plans a reality, an expert from Cruelty Free International says.
The EU’s draft Biotech Act promises faster clinical trial approvals and innovation incentives, but the industry warns that intellectual property provisions have limited appeal.
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.
Manufacturers are responding to a convergence of factors, but plans will miss the rebate dollars they have relied on in the current pricing model.
Deputy chief Jonathan Benger moves up to become NICE’s fourth-ever CEO. While the face may be familiar, the challenges are anything but as the HTA body has launched a new joint scientific advice process with the MHRA and will implement new cost-effectiveness thresholds driven by a US trade deal.
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.