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Good morning. Today, the Senate Finance Committee will vote on whether to advance RFK Jr.’s nomination for a vote on the Senate floor. Stay tuned for that.
In the meantime, let’s get into the rest of the biotech news of the day.
The need-to-know this morning
Merck’s 2025 guidance hit by Gardasil pause in China
Merck shares fell sharply in pre-market trading this morning after forecasting 2025 revenue in the range of $64.1-$65.6 billion — lower than analysts’ consensus sales forecast of $67 billion, as tabulated by Visible Alpha.
The pharma giant’s 2025 sales guidance reflects a decision to “temporarily pause” shipments of its HPV vaccine Gardasil to China, starting this month through “at least mid year” in order to draw down excess inventory, Merck said.
Gardasil is Merck’s second largest product behind the cancer drug Keytruda, but “macroeconomic factors,” including a broader China crackdown on corruption has hit Merck hard since last summer. Sales of Gardasil in the fourth quarter were $1.6 billion, down 17% from the same quarter in 2023.
Who is the man who could soon lead CMS?
Amid the hearings and news surrounding RFK Jr.’s nomination to lead HHS, there’s been much less commotion around Mehmet Oz, President Trump’s nominee to run CMS. Though some consumer advocacy groups have called Oz unqualified for the role, his Senate confirmation is generally viewed on Capitol Hill as all but assured.
So who is the man who could soon lead CMS? My colleague Tara Bannow brings us an in-depth profile of the surgeon turned TV host.
Oz has lately kept a low profile and hasn’t given any clues about his plans for the agency he’ll likely run. But what is clear is that, like most Republicans, he’s all in on privatized Medicare — he once called for Medicare Advantage For All.
He also has financial ties that could complicate his position. This past August, Oz’s YouTube channel featured a video urging viewers to buy private Medicare plans from his insurance agency sponsor, a company accused of misleading older adults and making repeated, unsolicited phone calls. And as of 2022, Oz owned hundreds of thousands of dollars worth of stock in major insurers he’d oversee in his government role.
Fact-checking claims about senators’ pharma ties
And to bring up RFK Jr. again — last week, he accused Sens. Bernie Sanders and Elizabeth Warren of being bought and paid for by Big Pharma. But it’s actually not true that those lawmakers have received tons of money from pharma companies, my colleagues Lev Facher and Rachel Cohrs Zhang report.
RFK Jr.’s supporters are using data from the website OpenSecrets to back up these claims.
But there’s a nuance to this data. OpenSecrets measures corporate donations by combining PAC spending with any contribution of $200 or more from any company employee. In other words: If an entry-level human resources officer at a pharmaceutical company wrote Sanders or Warren even a modest check, the website would count that sum toward the company’s total giving, no differently than a check written by the company’s PAC.
FDA OKs first xenotransplantation trial to start
United Therapeutics said the FDA has allowed it to begin the first clinical trial testing whether organs from gene-edited pigs could provide a viable option for patients in dire need of a transplant.
Over the last three years, United and a rival company, eGenesis, have transplanted genetically modified pig hearts or kidneys into several patients, but those procedures were done through compassionate use waivers from the FDA that allow doctors to treat individual patients with no viable alternatives. Those patients were already near death and died soon after the xenotransplants.
United’s new trial will focus on patients in need of kidney transplants. Researchers will first dose six patients with end-stage renal disease, and once those patients have all been followed for at least 12 weeks, United plans to expand its trial to up to 50 patients — enough, it hopes, to then file for FDA approval.
Read more from STAT’s Jason Mast.
Taxpayers should stop funding trials of industry cancer drugs
Nearly 70 years ago, National Cancer Institute launched a taxpayer-funded drug development program at a time when there was no private investment in oncology drugs. But now, as global oncology sales grow faster than any other therapeutic area, U.S. taxpayers should stop funding clinical trials of industry-owned drugs and the NCI should overhaul this program, argues University of Chicago professor Mark Ratain in a new opinion piece.
(An unnamed U.S. government employee also contributed to this piece. STAT agreed not to identify the person because of the freeze on federal workers communicating with the public.)
The current trials funded by the NCI are almost exclusively focused on drugs owned by private industry, Ratain and his co-author say. The government should instead focus on trials studying quality of life, financial sustainability and efficiency of cancer care, and comparative effectiveness, they argue.