What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs.
Of all the U.S. SEC’s recent proposed rules to make going, and staying, public more attractive, perhaps the most beneficial for biopharma and med-tech startups is the amendment that would give public companies the flexibility to file semi-annual rather than quarterly reports, Ben Bradford, head of external affairs at Massbio, told BioWorld.
Ready or not, the future has arrived. Novel AI and brain-computer interface (BCI) systems are no longer confined to the realm of science fiction. As an increasingly intertwined human-machine model moves closer to adoption in real-world clinical and military practice, technological advances are sparking concerns over public health, ethics and national security.
For the second time this year, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) canceled a scheduled meeting due to a federal judge’s stay that keeps the panel from meeting with its current membership. Typically, ACIP meets three times a year – in February, June and October. The 2026 June meeting was slated for June 23-25. Whether the adcom meets in October will be up to the courts and how far Health and Human Services Secretary Robert Kennedy digs in his heels to maintain a hand-picked committee tilted toward his view of vaccines.
In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration.
The Centers for Medicare & Medicaid Services (CMS) proposed a rule June 12 that would codify the Inflation Reduction Act of 2022’s Medicare Drug Price Negotiation Program, establish new negotiation and drug benefit policies, and modify the fixed combination drug policy – the latter of which would negatively impact biopharmas attempting to extend lifecycles of blockbuster products.
The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
Nearly a year after Health and Human Services Secretary Robert Kennedy announced the U.S. was cutting off funding for Gavi, a global vaccine alliance, Secretary of State Marco Rubio said his department is reengaging with the organization in light of the ongoing Ebola outbreak in central Africa. In testifying before a June 2 Senate Foreign Relations Committee hearing, Rubio said the State Department made the decision to reengage a few weeks earlier with Gavi. He provided no detail of what that engagement looks like.
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance.
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