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FDA approval expands first-line targeted therapy in CLL/SLL
FDA approved pirtobrutinib (Jaypirca) for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma in adults without del(17p), expanding the noncovalent BTK inhibitor into...
GE HealthCare builds U.S. radiopharma capacity via Sofie Biosciences acquisition
GE HealthCare agreed to acquire Sofie Biosciences for $945 million in cash to expand its U.S. radiopharmaceutical manufacturing and distribution footprint. The deal is aimed at strengthening...
Shionogi doubles down on rare disease with $2B IntraBio buy
Shionogi agreed to acquire IntraBio for $2 billion upfront, extending its rare disease strategy with a commercially approved therapy for two inherited conditions. The deal also adds Aqneursa,...
CAR-T pathway safety guidance incorporates oral health practices
Hematologists are urging adoption of routine dental preventive care and oral health assessment as part of the CAR-T therapy pathway. The argument centers on infection-risk mitigation during the...
Vaxcyte’s pneumococcal vaccine clears Phase 3 endpoints and lifts shares
Vaxcyte reported that its 31-valent pneumococcal conjugate vaccine (VAX-31) met key endpoints in a Phase 3 trial in adults, setting up competitive positioning against established vaccines. The...
New oncology trial evidence reshapes bladder cancer chemo sensitivity
Preclinical research suggests BH3 mimetic drugs that target antiapoptotic Bcl-2 family proteins can resensitize bladder cancer cells to cisplatin. The work reported sensitization in both...
FDA expedites IND reviews to reduce barriers for trial entry
The FDA rolled out an expedited Investigational New Drug (IND) pilot program designed to address bottlenecks in early clinical trial entry. The initiative, part of HHS’s effort to onshore clinical...
Corporate financing accelerates next-gen mRNA manufacturing platform
Sensible Biotechnologies raised $47 million in a financing round to scale its integrated mRNA technology, including Series A funding and up to $20 million in non-dilutive support from the...
Clinical data and real-world evidence reinforce immunotherapy timing in breast cancer
Real-world data from Tokyo confirm that pembrolizumab combined with chemotherapy before and after surgery delivers event-free survival outcomes close to those reported in the KEYNOTE-522 trial...
Biotech VC and IPO activity highlights continued capital interest in targeted oncology assets
New funding and public-market activity underscored continued investor appetite for targeted oncology and platform-driven drug development. KymaThera raised $80 million in Series B to develop...
FDA approval expands targeted therapy for untreated CLL
The FDA has approved pirtobrutinib (Jaypirca) for adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) lacking del(17p), based on results from...
Phase 3 win lifts Vaxcyte’s pneumococcal vaccine—shares surge
Vaxcyte reported that its 31-valent pneumococcal conjugate vaccine, VAX-31, met key primary immunogenicity endpoints in a Phase 3 trial in adults 50 and older, triggering a sharp market reaction....
Company strategy: Shionogi expands rare-disease footprint with $2B IntraBio deal
Shionogi agreed to pay $2 billion upfront to acquire IntraBio, adding a marketed treatment for two inherited conditions—an expansion of its rare-disease strategy. The purchase underscores how big...
New biotech financing: RougeTx launches with $58M Series A for once-daily HHT
RougeTx raised $58 million in a Series A to advance an oral, once-daily therapeutic candidate for hereditary hemorrhagic telangiectasia (HHT). The funding supports early clinical progression and...
Regulatory acceleration: FDA launches expedited IND pilot tied to clinical bottleneck reduction
The FDA rolled out an expedited Investigational New Drug (IND) pilot program intended to reduce bottlenecks in early development submissions. The IND pilot is framed as part of HHS efforts to...
Payer/policy and access: Medicaid patients abandon GLP-1 weight-loss therapy quickly
A claims-based study of nearly 4,000 Mississippi Medicaid members found that adherence to GLP-1 weight-loss drugs falls sharply within months, with the steepest declines linked to younger age,...
Clinical evidence: PSMA PET/CT improves detection before biopsy in MRI-negative men
A prospective study found that PSMA PET/CT-guided targeted biopsy detects clinically significant prostate cancer in 37% of men with negative or inconclusive MRI—nearly doubling detection when...
Trial data realism: clinical risk scores cannot replace neurofilament biomarkers in ALS
A reanalysis of the MIROCALS trial concluded that while the TRICALS clinical risk score provides useful prognostic information in ALS, it cannot substitute for cerebrospinal fluid neurofilament...
New therapy evidence: GLP-1 receptor agonists linked to survival after traumatic brain injury surgery
A brief communication reports an association between GLP-1 receptor agonist use and improved survival among patients undergoing surgery for traumatic brain injury, drawing on clinical data from...
Health systems and operations: Mount Sinai deploys real-time EHR-to-EDC to cut trial data entry
Mount Sinai’s Tisch Cancer Center deployed real-time EHR-to-EDC technology across all 16 cancer disease groups, cutting clinical trial data-entry time by more than half while reporting 100% data...