Tag Archive for: inflammatory bowel disease

The company forecasted revenue growth of 5-6% for the next year, as it banks on strong demand for cancer treatments Darzalex and Carvykti and resilient sales of blockbuster drug Stelara.

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. 

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.

AstraZeneca said on Friday it had signed an agreement with Quell Therapeutics potentially worth more than $2 billion to develop cell therapies that could cure autoimmune diseases.

The agency’s decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie, Pfizer, and Johnson & Johnson.

Sanofi licensed CytoReason’s inflammatory bowel disease model in a multi-million dollar bid to identify new therapies for IBD and Crohn’s and colitis.

Last year CDER approved 37 new drugs never before approved or marketed in the U.S., known as “novel” drugs, as noted in its annual New Drug Therapy Approvals report. The agency also approved drugs in new settings, such as for new uses and patient populations.

Nimbus Therapeutics scored a $496 million payday through a collaboration and licensing deal with pharma giant Eli Lilly for potential therapeutics for metabolic diseases, the companies announced Tuesday.

Nearly one third of patients with ulcerative colitis who received an experimental Pfizer Inc. medicine in a clinical trial were in remission after a year of treatment, the drugmaker said on Tuesday.