Remibrutinib clears pivotal multiple sclerosis tests with no liver safety signal as Novartis eyes approvals
Remibrutinib wins two Phase III multiple sclerosis trials as Novartis prepares global filings. See what the results mean for the BTK race.
Pharma & Biotech
Medical Devices & Diagnostics
Could Alzheimer’s testing move out of specialist centers? Roche’s pTau217 blood test just cleared a major hurdle
Roche has secured FDA clearance for Elecsys pTau217, a single-biomarker blood test capable of supporting both rule-in and rule-out assessment of Alzheimer’s-associated amyloid pathology across primary and specialty care.
Medical Devices & Diagnostics
FDA expands Roche HER2 companion diagnostics for ZIIHERA in gastroesophageal cancer
Roche has secured expanded FDA approval for two HER2 companion diagnostics used to identify gastroesophageal adenocarcinoma patients who may be eligible for Jazz Pharmaceuticals’ ZIIHERA.
Pharma & Biotech
Genentech signs $1bn-plus DualityBio deal to develop next-generation ADCs
Genentech has entered a global collaboration with DualityBio to develop antibody-drug conjugates using novel payloads designed to address tumors resistant to widely used topoisomerase inhibitor ADCs.
Pharma & Biotech
Hanmi lands up to $2.3bn Genentech deal as non-incretin obesity drug HM17321 reaches its first human test
Genentech has licensed HM17321 outside South Korea for $190 million upfront and up to about $2.3 billion in total potential payments, betting on a UCN2 mechanism designed to reduce fat while preserving lean mass.
Pharma & Biotech
Why Roche is spending $750m on the part of biologics manufacturing patients rarely see
Genentech will spend about $750 million to add end-to-end device fill-finish capabilities in Oregon, doubling its Hillsboro site and targeting commercial operations in 2031.
Pharma & Biotech
Genentech’s $2bn Holly Springs bet is taking shape, but the hardest manufacturing work is still ahead
Genentech’s $2 billion Holly Springs plant reaches a key milestone as Roche builds U.S. manufacturing capacity for future metabolic medicines.
Pharma & Biotech
What Rohan Palekar’s appointment means for Newleos and its anxiety drug pipeline
Newleos names Rohan Palekar board chairman as three neuropsychiatry programs move through clinical proof-of-concept. Read the analysis.
Pharma & Biotech
What IDEAYA Biosciences’ IDE892 expansion means for MTAP-deleted cancers
IDEAYA advances IDE892 into expansion after reaching target exposure, but clinical response and safety data remain the decisive test.
Medical Devices & Diagnostics
Roche’s new vaginitis PCR test is FDA-cleared, but the real commercial test starts inside laboratories
Roche’s cobas BV/CV assay gains FDA clearance for combined BV and Candida testing, setting up a 2026 U.S. laboratory launch.