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Regulatory decision risk: melanoma oncolytic therapy
The FDA twice declined to approve Replimune Group’s RP1, an oncolytic immunotherapy for melanoma previously granted breakthrough therapy status, raising fresh concerns for developers relying on...
M&A and corporate strategy
UCB moved to expand its autoimmune pipeline by backing Ken Song’s T cell engager ambitions with a reported $2 billion bet on Candid, a company advancing T cell engager programs designed for...
Early oncology signals and trial risk transparency
Erasca’s shares sank 53% amid disclosure around a death connected to ERAS-0015’s treatment-related adverse event timeline in earlier data. The precision oncology company developing an oral pan-RAS...
Translational oncology: molecular engineering with AI
Researchers used AI-guided design to partially eliminate isoleucine from proteins in an engineered Escherichia coli system by proposing structurally similar replacements across dozens of bacterial...
Immunology and neonatal lung disease biology
A study identifying CD44+ monocytes as drivers of inflammation in very premature infants advances mechanistic understanding of bronchopulmonary dysplasia (BPD), according to the report. The...
Biomarkers and diagnostics in critical neonatal care
Work on bridging biomarker gaps for very low birth weight (VLBW) sepsis tests highlights ongoing unmet needs in neonatal diagnostics. Sepsis remains a leading cause of morbidity and mortality in...
Neurobiology pathways linked to disease and development
A Nature Communications multicohort analysis links small-for-gestational-age constraints to long-term pulmonary impairments via axon guidance pathways. Investigators say the study provides “first...
Clinically oriented oncology dosing/response innovation
A Karolinska Institutet-led study reported that low-dose endoxifen, an active metabolite of tamoxifen, can significantly reduce mammographic breast density with fewer side effects, with results...
Oncology: T-cell engager economics and UCB’s $2B bet
UCB has committed $2 billion toward expanding Candid’s T-cell engager platform, signaling a major push into engineered cell-engaging therapies for autoimmune disease. The investment underscores...
Oncology: Longer-term RET inhibitor data published
Rigel Pharmaceuticals published final results from the Phase 1/2 ARROW study of pralsetinib (Gavreto) for RET fusion-positive metastatic NSCLC in the Journal of Clinical Oncology, adding 42 months...
Regulatory: FDA again declines approval for melanoma oncolytic virus
The FDA has twice opted not to approve Replimune’s oncolytic immunotherapy RP1 for melanoma despite breakthrough therapy designation and fast-track expectations, according to the account provided....
Clinical risk and market impact: Erasca shares tumble after reported death
Erasca’s shares fell sharply after the company disclosed a fatal adverse event connected to ERAS-0015, its oral pan-RAS molecular glue in early trials. The disclosure accompanied preliminary...
Neonatology immunology: CD44+ monocytes implicated in BPD hyperinflammation
Researchers have identified CD44+ monocytes as key drivers of inflammation in bronchopulmonary dysplasia (BPD) in very premature infants, tying a specific immune cell phenotype to the...
Clinical diagnostics and biomarker science: micro-histotripsy for better FNA
A new method combining shock-scattering micro-histotripsy with fine needle aspiration (FNA) aims to improve how much cellular material is retrieved for downstream biomarker profiling and...
Synthetic biology and protein engineering: removing isoleucine from E. coli proteins
Scientists report progress toward organisms with fewer amino-acid building blocks by partially eliminating isoleucine usage in Escherichia coli ribosome proteins, with the research published in...
Neuroimmunology and genetics: cGAS–STING hyperactivation in Down syndrome liver inflammation
A study identifies cGAS–STING hyperactivation as a mechanism that may help explain the elevated risk of liver inflammation seen in individuals with Down syndrome. By linking innate immune sensing...
Public health policy meets oncology screening economics: AI in UK breast screening
A study in the British Journal of Cancer assesses the cost-effectiveness of integrating AI into the UK breast cancer screening program alongside traditional mammography. The analysis evaluates the...
Foodborne/antiviral mechanism: African swine fever virus targets p300 for degradation
Researchers report that African swine fever virus (ASFV) uses an MGF505-1R protein to degrade the host factor p300, helping the virus manipulate cellular machinery to support replication and...
Oncology regulatory and clinical readouts
The FDA rejected RP1, an engineered oncolytic herpesvirus therapy by Replimune Group, despite earlier “breakthrough therapy” designation tied to promising melanoma trial results. The agency has...
Biotech funding and IPO momentum
Biotech capital markets remain active, with April bringing the biggest month for IPO proceeds in more than five years. Four new biotech companies priced upsized offerings, raising $1.5 billion,...