Tag Archive for: ulcerative colitis

The approval marks a significant milestone for the American pharmaceutical company in the field of UC, following the approval by the FDA in October 2023 and the EMA approval in February 2024.

The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.

The agency’s decision will help Lilly enter a sector, where drugs from rivals such as Abbvie, Pfizer, and Johnson & Johnson are already jostling for a share of the multi-billion dollar market.

Zymfentra is the first FDA-authorized subcutaneous formulation of infliximab, according to Celltrion’s announcement. The therapy is indicated for patients who had previously undergone intravenous infliximab treatment.

Today Pfizer announced the FDA’s approval of VELSIPITY, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC), a condition that produces debilitating symptoms such as chronic diarrhea with blood and mucus, abdominal pain, and urgency and affects approximately 1.25 million people in the United States. 

Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.

The sale of the drug could be announced in the coming days, the report said, citing people familiar with the matter. The talks could still fall apart and another suitor could swoop in, it added.

Merck finalized its acquisition of immune-focused Prometheus Biosciences for approximately $10.8 billion, scoring five clinical and pre-clinical candidates for inflammatory bowel and immune-mediated diseases on Friday.

British drugmaker AstraZeneca (AZN.L) said on Thursday it would stop developing its drug brazikumab to treat inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.

Merck will acquire immune-focused Prometheus Biosciences for approximately $10.8 billion, scoring five clinical and pre-clinical candidates for inflammatory bowel and immune-mediated diseases.