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Pancreatic cancer clinical breakthroughs with RAS-pathway drug daraxonrasib
Revolution Medicines escalated its daraxonrasib momentum at AACR, reporting updated first-line metastatic pancreatic ductal adenocarcinoma (PDAC) data across monotherapy and combination cohorts....
Autoimmune CAR-T moves toward FDA review after registrational stiff-person syndrome results
Kyverna Therapeutics disclosed full registrational trial results for mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome (SPS), strengthening the case for what could become the...
Regulatory approval reshapes HIV treatment options with Merck’s once-daily Idvynso
The FDA approved Merck & Co.’s once-daily HIV regimen Idvynso (doravirine/islatravir), giving patients a new option and increasing competitive pressure on existing standard therapies. The approval...
Medicare coverage decision pressures obesity drug access via BALANCE delay
CMS indefinitely delayed its Medicare BALANCE model—intended to open Medicare Part D coverage pathways for obesity drugs—after a lack of participation by insurers. Instead, the agency extended its...
Next-wave anti-inflammation drug claims large hs-CRP reduction in early human data
BioAge reported Phase 1 results for BGE-102, describing an 86% reduction in hs-CRP after three weeks at a 60 mg dose in people with obesity and elevated inflammation. The company said 87% of...
Soleno exits Europe for discount after thin approval path for genetic obesity drug
Soleno Therapeutics sold at a discount to Neurocrine amid dwindling European prospects for its genetic obesity program, underscoring how regulatory risk outside the U.S. can compress valuations...
CGT manufacturing quality risk remains dominated by viral contamination challenges
A new analysis says the cell and gene therapy (CGT) industry still relies primarily on robust raw-material testing and screening because current viral inactivation methods can be too harsh for...
Clinical-grade manufacturing automation speeds monoclonal cell line development
Sartorius launched the CellCelector CLD, an automated imaging and cell isolation platform designed to compress monoclonal cell line development timelines. The system is built to scan and track...
Gene therapy for deafness adds new long-term efficacy evidence
Researchers published updated long-term outcomes from a multicentre gene therapy trial targeting DFNB9, a hereditary deafness caused by OTOF mutations. The report in Nature (2026) describes...
Biopharma portfolio reshuffle: BridgeBio oncology spinoff changes leadership to push KRAS work
BridgeBio’s oncology spinoff, BridgeBio Oncology Therapeutics, announced an executive reshuffle aimed at accelerating its KRAS strategy. The company is replacing CEO Eli Wallace with CSO Pedro...
Pancreatic cancer therapies and early-detection push
Revolution Medicines presented updated first-line pancreatic ductal adenocarcinoma (PDAC) data alongside earlier late-stage results, reinforcing its push to build a RAS-targeting franchise in one...
AI-based trial planning to shorten clinical operations timelines
Ryght AI launched a clinical trial site “search engine” aimed at compressing site selection timelines by ranking research centers using disease expertise and other study-fit inputs. The company...
CAR T for autoimmune disease moves toward FDA review
Kyverna Therapeutics reported updated registrational Phase II results for its CAR T candidate mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome, strengthening the case for a...
FDA action expands HIV treatment options for Merck
The FDA approved Merck’s once-daily HIV regimen Idvynso, adding a two-drug option for adults with HIV-1 who are virologically suppressed. The approval comes as Merck targets a market long...
U.S. Medicare coverage delay hits obesity-drug access experiment
CMS indefinitely delayed the Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model for Medicare coverage of obesity drugs, after insurers did not sign up for the...
CGT manufacturing: dual-hemisphere partnership to speed gene-therapy scale-up
Andelyn Biosciences and South Korea-based ENCell signed a collaboration to create a manufacturing bridge between the U.S. and Asia-Pacific. The companies positioned the agreement as a...
Drugmakers exit and reset RIPK1 and TIGIT strategies
Eli Lilly and Rigel Pharmaceuticals broke the remainder of their RIPK1 alliance, extending a pattern of large-deal pullbacks in a crowded inflammation and oncology target space. The separation...
Inflammation and cardiovascular risk drug early data
BioAge reported early Phase 1 data for its inflammation-targeting candidate BGE-102, showing a rapid reduction in high-sensitivity C-reactive protein (hs-CRP) in people with obesity and elevated...
Company finance and pipeline acceleration via major takeouts
Biogen consolidated felzartamab rights with an $850 million deal with TJ Biopharma, closing the loop on a multi-year license arrangement and expanding the company’s control of the CD38-directed...
Adaptive patient risk stratification using PET metabolic volume after CAR T
Researchers reported that a PET-derived metabolic tumor volume (MTV) biomarker outperformed traditional risk scoring in predicting progression-free survival for patients with large B-cell lymphoma...