Gastrointestinal

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.

Biologic treatments for inflammatory bowel disease, Crohn’s disease and ulcerative colitis, are growing apace in Europe, buoyed by biosimilar competition for the first wave of treatments like infliximab and adalimumab. Generics Bulletin looks at what is on the horizon in the growing, multi-billion-dollar IBD space.

Deal snapshot: The German pain-management specialist is acquiring Valinor to gain additional geographic rights to the gastrointestinal drug Movantik and add to its US product portfolio.

The acid reducer was approved by the US FDA for a substantially larger indication in non-erosive gastroesophageal reflux disease but will have to prove itself commercially against PPIs.

In this week's podcast edition of Five Must-Know Things: Q1’s top 10 drugs; Pfizer’s R&D leadership succession; Lilly bolsters IBD pipeline; first half deal volume up but value down; and EU firms’ China sentiment plummets.

With only one inflammatory bowel disease product, Lilly is betting big on Morphic and its Phase II oral integrin MORF-057, which would directly compete with Takeda blockbuster Entyvio.

Ensho Therapeutics is raising series A cash to develop Phase II-ready NSHO-101 (EA1080), a third oral ɑ4β7 integrin inhibitor attempting to take on Takeda’s blockbuster injectable Entyvio.

Phase IIb data for Auxora in an acute pancreatitis subpopulation is expected to set up the CRAC channel inhibitor for Phase III in that indication while suggesting positive read-through for AKI.

Andrew Trister, Verily’s chief medical and scientific officer, discusses Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Plus, the Google health tech spinout's plans for the Study Watch, the Alzheimer’s research landscape, and AI development and regulation in a new era of uncertainty.

Andrew Trister, Verily’s chief medical and scientific officer, spoke with Medtech Insight at the HLTH Europe conference about Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Trister also talked about plans for the Study Watch and offered views on the Alzheimer’s research landscape and AI development and regulation in a new era of uncertainty.

AbbVie's rival interleukin-23 drug Skyrizi is now approved in the US for both principal types of inflammatory bowel disease – ulcerative colitis and Crohn’s disease. Tremfya may not be too far behind.

Implantica AG continues European rollout of RefluxStop, a non-active, laparoscopically implanted device for treating gastroesophageal reflux disease (GERD) that offers key advantages over other surgical interventions and drug therapy, according to the company. CEO Peter Forsell discusses global market opportunity and the firm’s growing body of research to support reimbursement.

The US major's blockbuster is already well established as a treatment for Crohn’s disease but the latest thumbs-up from the US FDA means Skyrizi is the first interleukin-23 inhibitor approved for both principal types of inflammatory bowel disease.

Deal snapshot: AbbVie joins peers Merck & Co., Roche and Pfizer with a TL1A-targeted antibody for potential therapy in inflammatory bowel disease, paying $150m up front.

In the emerging field of therapeutic endoscopy, Creo Medical’s Speedboat devices are advancing minimally invasive treatment by combining advanced bipolar radiofrequency and super high frequency microwave energy in a single device, says CTO and founder Chris Hancock.

In the emerging field of therapeutic endoscopy, Creo Medical’s Speedboat devices are advancing minimally invasive treatment by combining advanced bipolar radiofrequency and super high frequency microwave energy in a single device, says CTO and founder Chris Hancock.

Amended complaint filed 21 May after US Attorney General in March said the federal and state governments, named as co-plaintiffs, wouldn’t intervene and the court ordered the complaint unsealed. Complaint, initially filed in 2019, is critical of FDA, generally alleging agency failed to conduct sufficient oversight and evaluation of GSK’s testing data for ranitidine.

Johnson & Johnson tested Tremfya against its established Stelara as the “benchmark” in IBD. Tremfya, already up for approval in ulcerative colitis, is planned for filing in Crohn’s later in 2024.