CHMP meeting highlights – March 2023
In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
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In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.
AMJEVITA™, the first biosimilar to Humira® is now available in the US, based on four years of real-world experience in over 300,000 patients.
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
The US biosimilars market experienced dramatic growth in 2022, particularly for therapies helping to treat oncological and inflammatory conditions, Amgen suggested in a recent report.
MIT researchers have developed a robotic capsule that tunnels through mucus in the GI tract to deliver large oral protein-based drugs like insulin.
NICE has recommended the drug Zeposia® (ozanimod) for moderate to severe cases of ulcerative colitis.
Phase III study results show ulcerative colitis patients treated with etrasimod achieved statistically significant improvements in clinical remission compared to placebo.
The European Commission (EC) has granted Zeposia® (ozanimod) a marketing authorisation to treat people with ulcerative colitis.
Two new analyses displayed positive data supporting Stelara for the treatment of Crohn's disease and ulcerative colitis.
Janssen has released abstracts for four studies evaluating Stelara® (ustekinumab) in Crohn's disease (CD) and ulcerative colitis (UC).
In the trial, 74 percent of participants responded to upadacitinib and 33 percent of patients achieved clinical remission.
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
A Phase I clinical trial of remestemcel-L delivered by an endoscope to patients with Crohn’s disease and ulcerative colitis has commenced.