INTENT Biologics secures FDA pediatric waiver, clears path to late-stage DFU trial for PEP Biologic

By on    Pharma & Biotech  

INTENT Biologics secures FDA pediatric waiver, clears path to late-stage DFU trial for PEP Biologic

The U.S. Food and Drug Administration (FDA) has granted INTENT Biologics a full pediatric study waiver for its lead candidate, PEP Biologic, under IND 019567. The waiver, part of an agreed Initial Pediatric Study Plan (iPSP), applies to the product’s adult-focused development for diabetic foot ulcers (DFUs), a serious chronic wound indication preparing for pivotal […]

Can GSK’s $2.2bn acquisition of RAPT Therapeutics reshape the food allergy treatment landscape with ozureprubart?

By on    Pharma & Biotech  

Can GSK’s $2.2bn acquisition of RAPT Therapeutics reshape the food allergy treatment landscape with ozureprubart?

GSK plc has signed a definitive agreement to acquire RAPT Therapeutics Inc., a clinical-stage biopharmaceutical company based in California, in a transaction valued at approximately $2.2 billion. The centerpiece of the deal is ozureprubart, a long-acting anti-IgE monoclonal antibody currently undergoing Phase IIb evaluation for the prophylactic treatment of food allergies. With topline data from […]

Is insitro’s TherML platform finally delivering on the AI-native promise for biologics and small molecules?

By on    Pharma & Biotech  

Is insitro’s TherML platform finally delivering on the AI-native promise for biologics and small molecules?

insitro has announced the acquisition of CombinAbleAI and launched its new TherML platform, a modality-agnostic, AI-powered system that integrates small molecules, oligonucleotides, and biologics into a unified therapeutic design stack. The move signals a strategic attempt to industrialize AI-native drug discovery across modalities while reducing late-stage attrition risks. What makes this acquisition different from typical […]

1 2 3 4