U.S. Food and Drug Administration Pushes Sweeping Reforms to Speed Trials and Expand Authority
Summary:
Under Commissioner Marty Makary, the FDA has proposed a broad legislative agenda for 2027 that includes a faster, risk-based alternative to the traditional IND pathway, expanded transparency in regulatory decisions, and stronger enforcement powers over drug safety, manufacturing, and misleading advertising. The plan also aims to boost U.S. competitiveness by supporting domestic generic production, streamlining biosimilar approvals, and permanently extending incentives like the rare pediatric disease voucher program.
President Donald Trump Reinstates Pharma Tariffs with Broad Exemptions
Summary:
The Trump administration has reintroduced 100% tariffs on imported pharmaceuticals under national security provisions, but carved out major exemptions for generics, biosimilars, and companies complying with U.S. pricing and manufacturing expectations, limiting the immediate impact on the industry.
White House Proposes Major Cuts to U.S. Department of Health and Human Services Budget
Summary:
The White House has proposed a 12.5% cut to HHS discretionary funding for 2027, reducing the budget to $111 billion and targeting major reductions at agencies like the National Institutes of Health alongside the elimination of several research programs.
Gilead Sciences Acquires Tubulis to Expand ADC Pipeline
Summary:
Gilead Sciences will acquire Tubulis for $3.15 billion upfront plus up to $1.85 billion in milestones, strengthening its position in the fast-growing antibody-drug conjugate (ADC) space with a promising late-stage candidate. The deal centers on TUB-040, an ADC showing strong early efficacy in ovarian and lung cancers, as Gilead continues an aggressive strategy to build its oncology pipeline and ADC capabilities.
Novavax Shifts to Partnership Model to Scale Vaccine Platform
Summary:
Novavax is pivoting to an “amplification strategy,” focusing on licensing its Matrix-M adjuvant through partnerships with major players like Sanofi and Pfizer instead of maintaining costly commercial operations. This leaner model aims to expand the reach of its vaccine technology, reduce expenses, and generate long-term value through partnerships, milestones, and future royalties.
