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Dermatomyositis—Roivant’s brepocitinib becomes the first oral option
The FDA approved Roivant and Priovant’s brepocitinib for dermatomyositis, with the medicine marketed as Lisraya. It is the first major regulatory step for the oral drug and could expand Roivant’s...
Immunotherapy safety—first-dose tumor lysis syndrome reported with tarlatamab
A case report described a fatal tumor lysis syndrome episode after a single 1-mg starter dose of tarlatamab in a patient with relapsed small cell lung cancer. The complication emerged six days...
Regulatory and diagnostics—Roche expands FDA-cleared HER2 companion testing for Ziihera access
Roche received an expanded FDA clearance for diagnostic tests tied to Jazz Pharmaceuticals’ Ziihera, extending HER2 status assessment into additional gastric and gastroesophageal cancer settings....
Deals—McKesson to buy Precision Medicine Group to strengthen oncology services
McKesson agreed to acquire Precision Medicine Group for about $2.25 billion in an all-cash transaction, aiming to deepen clinical research and biopharma commercialization capabilities. The deal...
Oncology diagnostics commercialization—neoGenomics’ RaDar ST gains expanded MolDX coverage
NeoGenomics said its RaDar ST molecular residual disease (MRD) assay received expanded coverage from CMS’s MolDX program for immunotherapy response monitoring in late-stage solid tumors. The test...
Oncology companion biomarker testing in ADC trials—Natera and Angiex adopt Signatera MRD
Natera partnered with Angiex to use its Signatera MRD assay in Angiex’s Phase 1 trial of AGX101, a nuclear-delivered TM4SF1-directed antibody-drug conjugate. The collaboration includes...
Neuro—Micot’s TrkB agonist hits Phase 2 endpoints in acute ischemic stroke
Shaanxi Micot Pharmaceutical Technology reported that injectable TrkB agonist MT-200605 met Phase 2 endpoints in acute ischemic stroke. The program targets the BDNF/TrkB pathway, aiming to...
Maternal health R&D—Gates Foundation funds ProFound to discover preeclampsia biomarkers and targets
The Gates Foundation will invest up to $35 million in ProFound Therapeutics to identify biomarkers, drug targets, and candidate therapies for preeclampsia and eclampsia. The initial tranche is $20...
Epilepsy—SK Biopharmaceuticals buys Biohaven’s opakalim (BHV-7000) in $795M deal
SK Biopharmaceuticals agreed to acquire Biohaven’s epilepsy drug opakalim (BHV-7000) in a deal valued at up to $795 million, including $350 million at closing and $50 million due in 2027. The...
Regulatory approvals in rare autoimmune disease
The FDA has approved Roivant’s oral JAK inhibitor brepocitinib for dermatomyositis, launching the drug as Lisraya for the rare autoimmune condition. The approval marks Roivant’s first major U.S....
FDA approval for RAS-driven pancreatic cancer
Revolution Medicines won FDA approval for daraxonrasib (Rasonque), a once-daily oral pan-RAS inhibitor, in advanced pancreatic ductal adenocarcinoma. The agency’s decision covers patients who have...
Phase 3 progress for EoE immune therapy to challenge Dupixent
AstraZeneca and Amgen’s tezepelumab competitor Tezspire moved closer to expanding into eosinophilic esophagitis (EoE) after meeting Phase 3 goals. An eventual approval would give the therapy a...
Diagnostic coverage expansion for immunotherapy monitoring via MRD
NeoGenomics’ RaDar ST molecular residual disease assay received expanded coverage from CMS under MolDX for immunotherapy response monitoring in late-stage solid tumors. The update expands...
Oncology diagnostics: Roche expands FDA authorization tied to Jazz’s Ziihera
Roche secured expanded FDA authorization for companion diagnostic tests used to identify patients eligible for Jazz Pharmaceuticals’ Ziihera (zon). The additional clearance allows Roche’s PATHWAY...
AI-enabled clinical trial support and site governance
A new industry position highlights a growing disconnect in AI use across clinical trials: sponsors and CROs push algorithmic tools to sites, while sites often lack governance, transparency, and...
Gates Foundation funding accelerates biomarker target discovery for preeclampsia
ProFound Therapeutics said the Gates Foundation will invest up to $35 million to identify proteins, drug targets, and drug candidates for preeclampsia and eclampsia. The program uses ProFoundry...
Biopharma dealmaking: McKesson to acquire Precision Medicine Group for $2.25B
McKesson agreed to acquire Precision Medicine Group in an all-cash transaction valued at about $2.25 billion to expand oncology and biopharma services across the drug lifecycle. Precision brings...
Clinical-stage innovation platform: NGS MRD test adopted into ADC trial monitoring
Natera and Angiex announced they will use Natera’s Signatera minimal residual disease test in a Phase 1 trial of AGX101, a nuclear-delivered antibody-drug conjugate targeting TM4SF1. The companies...
Med-tech safety and FDA action: Abiomed removes Impella device over reported deaths and injuries
Abiomed, a Johnson & Johnson unit, is removing Automated Impella Controllers after an FDA alert tied the devices to 37 serious injuries and three deaths. The company attributed the issue to purge...
FDA approval for RAS-inhibitor in pancreatic cancer
The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for patients with advanced pancreatic ductal adenocarcinoma (PDAC) whose disease has progressed after chemotherapy. The approval...