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FDA approves first Stelara biosimilar, Wezlana
The US FDA has approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).
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Ulcerative colitis (UC)
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Alfasigma to acquire Jyseleca from Galapagos
31 October 2023 | By
Italy-based Alfasigma has agreed to acquire the Jyseleca (filgotinib) business from Belgian biotech Galapagos for €170 million.
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Roche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
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Sanofi and Teva to develop novel IBD treatment
Under a new agreement with Sanofi, Teva could receive up to $1.5 billion for its novel anti-TL1A therapy, a potential best-in-class option for inflammatory bowel disease (IBD).
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Takeda ulcerative colitis biologic receives FDA approval
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
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NICE recommends Eli Lilly ulcerative colitis biologic
The first IL-23p19 targeted biologic recommended by the National Institute for Health and Care Excellence (NICE) for moderately to severely active ulcerative colitis (UC) in adults in Great Britain is based on Phase III evidence of sustained clinical remission.
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Sandoz to commercialise mAb biosimilar candidate
A new commercialisation agreement between Sandoz and Samsung Bioepis’ for its ustekinumab biosimilar candidate, means Sandoz now has five potential high-value biosimilars anticipated to launch over the next two years.
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
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Microbiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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Merck to develop mAb through $10.8b acquisition
Through a $10.8 billion acquisition, Merck has agreed to buy Prometheus Biosciences to advance development of a novel monoclonal antibody for immune conditions.
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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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First biosimilar to HUMIRA® available in US
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.
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Citrate-free HCF of adalimumab biosimilar gets positive opinion
A positive opinion has been adopted by the CHMP for a citrate-free high concentration formulation of its biosimilar Hyrimoz® (adalimumab).
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Clinical trials authorised for 3D-printed ulcerative colitis drug
The FDA gives clinical trial clearance to 3D-printed colon-targeted oral drug for ulcerative colitis, to help improve safety of the dosage release.
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JAK inhibitors increase risk of cardiovascular problems and cancer, warns PRAC
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
