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FDA approval reshapes cardiovascular risk and epilepsy portfolios
Eli Lilly’s Mounjaro (tirzepatide) won FDA approval to reduce cardiovascular risk, adding a new label that could extend the blockbuster’s reach in cardiometabolic care. In parallel, Teva agreed to...
AstraZeneca heart gene-silencer setback at ESC
A surprise trial failure involving AstraZeneca and Ionis’ Wainua (eplontersen) has put pressure on RNA-targeting “silencer” therapies for TTR cardiomyopathy. Data discussed in connection with the...
Oncology: breakthrough FDA approval in pancreatic cancer and label expansion via diagnostics
Revolution Medicines secured a landmark FDA approval for daraxonrasib (Rasonque), a once-daily oral pan-RAS inhibitor for pancreatic ductal adenocarcinoma. Analysts characterized the regulatory...
Dealmaking: Genentech bets on DualityBio’s ADC payload platform
Genentech, part of Roche, agreed to pay DualityBio $45 million upfront to develop antibody-drug conjugates built around the company’s DUPAC payload platform, with milestone potential exceeding $1...
Early-stage portfolio: gene editing push at ESC and durable expansion plans
At ESC26, CRISPR Therapeutics said it will pursue the highest dose of its lipid-lowering gene editing therapy after presenting mixed durability results from early-stage data around a year after...
Biomarkers and real-world diagnostics: MRD coverage and workflows
NeoGenomics said its RaDar ST MRD assay received expanded coverage from CMS’s MolDX program to add immunotherapy response monitoring for late-stage solid tumors. The tumor-informed test uses...
Manufacturing and precision services consolidation
McKesson agreed to acquire Precision Medicine Group in a deal valued at about $2.25 billion, strengthening its oncology and clinical research services footprint. Precision Medicine Group...
Hospital and ecosystem: new deals to operationalize pharmacogenomics and infection control
Children’s Hospital Colorado signed a multi-phase agreement with GenXys Health Care Systems to integrate pharmacogenomic data into clinical workflows. The first phase focuses on processing genomic...
Immunotherapy risk signal: Fatal tumor lysis syndrome after starter dose
A case report in Respirology Case Reports described an initial 1-milligram dose of tarlatamab followed by fatal tumor lysis syndrome in a woman with relapsed small-cell lung cancer. The...
Pancreatic cancer breakthrough approval
The FDA has approved Revolution Medicines’ daraxonrasib (Rasonque) for advanced pancreatic ductal adenocarcinoma, marking the first approval of a drug specifically targeting a genetic driver in...
Antibody-drug conjugate licensing stakes rise
Genentech has expanded its ADC ambitions with a major licensing deal centered on DualityBio’s topoisomerase inhibitor payload platform. DualityBio said it will receive $45 million upfront and...
Regulatory: Roivant dermatomyositis drug clears FDA
The FDA approved Roivant’s brepocitinib, branded as Lisraya, for dermatomyositis—an oral therapy Roivant’s unit Priovant licensed from Pfizer. The approval provides a new steroid-sparing option...
AstraZeneca–Ionis heart drug fails after surprise setback
A high-profile heart drug program involving AstraZeneca and Ionis suffered a surprise failure, according to results discussed around the European Society of Cardiology meeting. The setback affects...
Cell therapy manufacturing dispute erupts at Cellares
Cellares said it is facing a major financial and operational blow after Bristol Myers Squibb terminated their manufacturing collaboration tied to Breyanzi (lisocabtagene maraleucel). The...
Epilepsy deals: Biohaven’s Kv7 asset gets commercial partner
SK Biopharmaceuticals agreed to acquire Biohaven’s opakalim (BHV-7000) epilepsy drug through a deal structured with $400 million at closing and up to $795 million total depending on milestones and...
Diverse regulatory and diagnostic progress in companion testing
Roche received FDA clearance expanding the use of its HER2 diagnostic tests tied to Jazz Pharmaceuticals’ Ziihera, extending patient identification beyond earlier approved stomach-cancer...
Biomanufacturing services deal: McKesson to acquire Precision Medicine Group
McKesson signed a definitive agreement to acquire Precision Medicine Group for about $2.25 billion in an all-cash transaction, aiming to expand clinical research and biopharma commercialization...
FDA / rare disease: Priovant’s Lisraya approval plus Roivant’s pipeline relevance
The FDA approval of Roivant’s brepocitinib for dermatomyositis reinforces how the agency’s decisions in rare autoimmune disease are continuing to shape commercial planning for “spoke” programs...
Clinical trial setback: Severe malnutrition therapies miss endpoints
An international Phase 3 trial testing pancreatic digestive enzymes and ursodeoxycholic acid in severely malnourished acutely ill children stopped early after interim analyses indicated neither...
Cardiovascular drug development: Cytokinetics’ nHCM pivotal data and regulatory pathway
Cytokinetics disclosed full pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy (nHCM), showing improvements in how patients felt and in exercise capacity. The...