Gastrointestinal

The payout will bring GSK closer to resolving lawsuits which have occupied it for years – though investors are now likely to focus on new product growth concerns at the UK firm.

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Exosome-based treatments hold promise, but their reality has not yet materialized in the form of compelling clinical data. Belgian biotech Exo Biologics’ CEO Hugues Wallemacq believes his company can help move the field forward, both through its own clinical programs and by offering high-quality exosomes to others in the field.   

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

The company will file a new drug application with the US FDA by the end of the year for tradipitant in a different indication, motion sickness.

The IL-23 inhibitor was approved by the US FDA for ulcerative colitis, joining AbbVie’s Skyrizi and Lilly’s Omvoh.

Supergut brand owner Uplifting Results Labs makes Gut Healthy GLP-1 Booster prebiotic fiber mix along with its snack bars and meal-replacement shakes available through GNC. IHerb launches supplements addressing side GLP-1 effects including nausea and pain, loss of muscle mass and changing blood sugar levels.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.    

GE HealthCare announced it will team up with AWS to build new generative AI models and applications that can help doctors find key patient information faster and help with diagnosing and treating patients.

Already abandoned for psoriasis and psoriatic arthritis, the failure of Ventyx's TYK2 inhibitor for Crohn’s disease signals the end of the project, leaving Takeda and Alumis as BMS's principal rivals in the field.