An FDA advisory panel recommended approval for a cancer blood test despite the test failing to meet its suboptimal surrogate endpoint in a randomized trial of 140,000 people. This decision paves the way for potential Medicare coverage under the recently passed Multi-Cancer Early Detection Screening Coverage Act.
Sources: STAT Biotech
A 100% Section 232 tariff on imported pharmaceuticals and active ingredients has officially taken effect, sparking widespread confusion across the biopharma sector. While major drugmakers managed to secure delays via most-favored nation agreements, smaller biotech firms are left directly exposed to the heavy financial levies as they try to navigate complex exemption pathways.
Sources: STAT Pharma
The Pharmaceutical Research and Manufacturers of America has filed a lawsuit challenging the Trump administration's Medicare Part B 'GLOBE' pilot program, arguing it exceeds statutory authority by tying US drug prices to lower international rates. Separately, federal health officials are drafting plans to allow compounding pharmacies to temporarily sell certain restricted peptides.
Sources: STAT Pharma
A Dutch court ruled that Merck infringed on a patent for the subcutaneous formulation of Keytruda, ordering a halt to its manufacturing and marketing in several European countries. The decision is part of a broader patent dispute with Halozyme Therapeutics, though the intravenous version of Keytruda remains unaffected.
Sources: STAT Pharma
Only the lower of two tested doses of admilparant met the main objective in an idiopathic pulmonary fibrosis trial, creating uncertainty regarding the drug's future prospects.
Sources: BioPharma Dive
Researcher Nick Desnoyer is engineering petunias with inducible genes that activate specific pigmentation pathways when exposed to dexamethasone, creating a living canvas for botanical art.
Sources: Asimov Press
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