BioStem acquires Neox and Clarix as BioTissue refocuses on eye care therapies
BioTissue exits surgical wound care to refocus on eye care innovation, selling Neox and Clarix lines to BioStem. Find out what this deal changes in MedTech.
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?
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 […]
Akeso’s gumokimab advances to NMPA review in ankylosing spondylitis: Is China’s IL-17 race entering a new phase?
Akeso’s gumokimab enters NMPA review for ankylosing spondylitis after Phase 3 success. Find out what this could mean for IL-17 therapies in China.
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 […]
Eli Lilly taps Chai Discovery to accelerate biologics with AI-generated candidates
Eli Lilly partners with Chai Discovery to deploy AI for antibody drug design. Find out what this means for the future of biologics R&D.
Ustekinumab biosimilar approved in Japan: Can Samsung Bioepis expand its global autoimmune footprint?
Samsung Bioepis secures Japan approval for its ustekinumab biosimilar with Nipro, marking a key step in Asia’s biosimilar adoption. Find out what this means.
Elanco wins USDA approval for Befrena, expanding mAb options in canine dermatitis
USDA approves Elanco’s Befrena for canine allergic dermatitis. Find out what it means for vets, pet owners, and the mAb dermatology race.
Can Mabwell’s anti-IL-11 antibody redefine scarring treatment through fibrosis reversal?
Mabwell doses first patient in Phase II trial of IL-11 antibody for pathological scarring. Find out what this means for fibrosis drug development.
Mabwell’s anti-ST2 antibody 9MW1911 cleared for U.S. Phase IIa trial: Could this reshape COPD biologics?
Mabwell Biopharmaceuticals has received Investigational New Drug (IND) clearance from the United States Food and Drug Administration to initiate a Phase IIa clinical study for its anti-ST2 monoclonal antibody, 9MW1911, in patients with moderate-to-severe chronic obstructive pulmonary disease. This regulatory milestone comes on the heels of a completed Phase IIa study in China, where Mabwell […]