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Precision oncology at AACR: KRAS targeting in NSCLC
Early-phase AACR 2026 data showed zoldonrasib producing objective responses in previously treated KRAS G12D–mutant non-small cell lung cancer (NSCLC), a population with no approved RAS-targeted...
Next-gen CAR T moves toward solid tumors
University of Pennsylvania researchers presented first-in-human phase I data for SynKIR-110, a “KIR-CAR” T cell therapy designed to reduce exhaustion risk in solid tumors. The approach uses a...
AACR 2026: Protein degradation and DNA repair inhibition
AstraZeneca researchers at AACR 2026 highlighted AZD-4956, a POLθ inhibitor designed to target microhomology-mediated end joining (MMEJ) in HRR-deficient tumors. By suppressing POLθ-driven backup...
Regulatory and payer policy: faster Medicare coverage for breakthrough devices
The FDA and CMS announced the RAPID coverage pathway to align regulatory review with Medicare coverage decisions for FDA-designated breakthrough medical devices. The program is designed to reduce...
Drug pricing and transparency: FDA rejection letters face legal pushback
An unnamed pharmaceutical company filed a citizen petition challenging the FDA’s practice of publicly releasing complete response letters (CRLs). The petition, dated April 20, argues the...
Diagnostics market and platform strategy: Roche absorbs MRD via SAGA deal and faces China headwinds
Roche reported a 7% year-over-year decline in diagnostics sales in Q1 2026, attributing headwinds primarily to ongoing healthcare pricing reforms in China. At constant exchange rates, diagnostics...
Neuroscience and gene therapy: long-term hearing outcomes emerge in DFNB9
A multicentre gene therapy trial targeting autosomal recessive deafness 9 (DFNB9) reported long-term success, with sustained safety and efficacy outcomes described in Nature in 2026. The treatment...
Company finance: Amneal expands with a $375M biosimilar acquisition
Amneal Pharmaceuticals is set to acquire a biosimilar company for $375 million upfront, a move positioned to expand its biosimilars footprint. The reported transaction value underscores continued...
Clinical trial signals in pancreatic cancer: first-line daraxonrasib and early combination data
Revolution Medicines presented updated phase I/II data at AACR 2026 showing daraxonrasib, its oral RAS(ON) multi-selective inhibitor, with tumor control signals in previously untreated metastatic...
Funding and platform infrastructure: AI-powered clinical site selection
Ryght AI launched a clinical trial site “search engine” aimed at compressing site selection cycles for sponsors and CROs. The tool ranks sites using disease expertise and program fit, drawing from...
FDA approval and competition in HIV
The FDA approved Merck’s Idvynso (doravirine/islatravir), a two-drug regimen for adults with HIV-1 who are virologically suppressed, expanding treatment options beyond Gilead’s Biktarvy. The...
Medicare coverage delay for obesity drugs
The U.S. Centers for Medicare and Medicaid Services indefinitely delayed the Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model for covering obesity drugs under...
Revolution Medicines expands pancreatic cancer dataset with first-line and combo data
Revolution Medicines reported updated phase I/II results for daraxonrasib in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) at AACR, adding first-line monotherapy and...
Autoimmune CAR-T nears FDA filing after stiff-person syndrome phase 2 results
Kyverna Therapeutics disclosed positive primary analysis results from its registrational phase II KYSA-8 trial of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome (SPS). The...
Pancreatic cancer chemo-resistance tackled via netrin-1 inhibition
Netris Pharma presented positive phase Ib data for NP-137, its first-in-class netrin-1 inhibitor, aimed at reducing chemotherapy resistance in pancreatic cancer. The results suggest the drug can...
CAR T and immunotherapy execution risk: trial terminations in TIGIT collaboration
Gilead Sciences and Arcus Biosciences ended parts of their TIGIT collaboration after a phase 3 setback. The partners discontinued the STAR-121 late-stage study of domvanalimab in metastatic NSCLC...
Diagnostics performance and clinical validation in pancreatic cancer screening
ClearNote Health advanced commercialization steps for its pancreatic cancer early detection test, Avantect Pancreatic Cancer, presenting updated performance after adding a glycan biomarker CA19-9...
Regulatory and device momentum in dialysis access
Xeltis received CE mark approval for its Axess restorative vascular access conduit for hemodialysis. The company also released 12-month durability data from an EU pivotal trial, reporting...
Biogen consolidates rights to felzartamab in Greater China
Biogen secured full felzartamab rights in Greater China through an $850 million deal with TJ Biopharma, including a $100 million upfront payment and milestones. The transaction consolidates...
CGT quality-control focus: viral contamination remains a manufacturing gap
A new analysis highlights that viral contamination continues to pose a bottleneck for cell and gene therapy (CGT) quality control, with raw material testing still the foundation because existing...