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Protein degradation partnerships expand in cancer pipelines
Gilead exercised an option to license Kymera Therapeutics’ preclinical molecular glue degrader targeting CDK2, injecting another candidate into a rapidly expanding oncology pipeline. Under the...
R&D platform funding: Stipple Bio emerges with $100M Series A for ADC epitope selection
Stipple Bio came out of stealth with a $100 million Series A focused on advancing an ADC program and scaling its epitope-selection platform. The company’s lead asset, STP-100, is an antibody-drug...
Biopharma commercialization data: Tempus expands Gilead real-world AI collaboration
Tempus expanded its data-and-AI collaboration with Gilead, adding access to broader multimodal datasets and Tempus’ AI platform for oncology drug development. Tempus said the expanded deal builds...
CAR-T response in autoimmune disease with a long-running clinical case
A five-year follow-up narrative highlights how CAR-T therapy continues to surprise investigators in autoimmune disease, centered on a case treated around Georg Schett’s research program. The story...
FDA payment and policy pressure: Shift to reward-based America First PDUFA rules
A policy update described by BioCentury says the FDA is moving from a punitive approach to a reward-based “America First” framework under PDUFA. The reauthorization is framed as reducing fees by...
Single-cell toxicity startup DeepCyte launches with seed funding
DeepCyte launched with $1.5 million in seed funding to commercialize single-cell drug toxicity prediction tools. The company said its MetaCore platform pairs laser-based single-cell sampling with...
Neurodegeneration biomarker: Plasma p-tau217 links to amyloid-β in synuclein disease
Researchers reported in npj Parkinson’s Disease that plasma phosphorylated tau 217 (p-tau217) can detect amyloid-β accumulation in neurodegenerative diseases marked by synuclein pathology. The...
Women’s health evidence gap and market imbalance in menopause care
A new report argues that menopause remains underserved by evidence-based therapeutics despite growing consumer attention and a rapidly expanding menopause market. The piece highlights structural...
CAR-T financing and pipeline expansion ahead of IPO
Oricell Therapeutics said it raised more than $100 million in a pre-IPO round to support development of Ori-C101, a GPC3-targeted autologous CAR-T aimed at hepatocellular carcinoma. The company...
ADC and degrader-antibody conjugate partnerships
Roche is expanding its cancer modality bets with a new pact that merges antibody-drug conjugation and targeted protein degradation. In a collaboration with C4 Therapeutics, Roche agreed to pay $20...
Regulatory and FDA posture shifts for innovation programs
BIOCENTURY reported that FDA is shifting away from a punitive structure under the “America First” PDUFA framework and toward a reward-based model. The change would reduce first-in-human-related...
Company exits and M&A momentum signals renewed dealmaking
Biopharma deal activity surged as March closed with a flurry of large transactions, according to Jefferies’ M&A scorecard coverage. The report said biopharma companies completed seven deals of...
GLP-1 market and competitive launch dynamics
Lilly said it launched Foundayo, its oral obesity pill, pushing the oral GLP-1 race into a new phase against Novo Nordisk’s Wegovy tablet. The company won FDA approval for Foundayo last week, and...
Diagnostics and regulatory clearance for home HPV screening
Waters said its BD Onclarity HPV Self-Collection Kit and BD Onclarity HPV Assay received 510(k) clearance from the FDA. The company positioned at-home self-collection as a way to improve access to...
FDA device-related enforcement actions and removals risk
The FDA issued a warning letter to Medline over issues with its Namic brand angiographic control syringes and manifolds used for radiographic contrast media administration. The agency identified...
Oncology immunology and targeted molecular mechanisms
Researchers reported mechanistic cancer biology implicating NAT10 in both chemotherapy resistance and immune evasion in gastric cancer. The findings, published in Cell Death Discovery, describe...
Biotech early-stage funding and platforms for ADC differentiation
Stipple Bio emerged from stealth with a $100 million Series A round to advance STP-100, an antibody-drug conjugate designed to prevent off-target toxicity. The company says STP-100 uses...
Cell-free DNA methylome profiling for prostate cancer prognosis
Researchers reported that genome-wide methylome profiling of circulating cell-free DNA can predict outcomes in castration-resistant prostate cancer. The study described a new approach designed to...
CAR-T funding and clinical push in China
Oricell Therapeutics, the Shanghai-based cell therapy developer, raised $100 million in its final pre-IPO financing round as it advances a GPC3-targeted autologous CAR-T for hepatocellular...
Big Pharma expands into protein degradation via molecular glue
Gilead exercised an option to license Kymera Therapeutics’ preclinical protein degrader KT-200, paying $45 million as the drugmaker builds out an oncology pipeline focused on targeted protein...