Gastrointestinal

Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab

Johnson & Johnson has submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) to extend the use of the human interleukin (IL)-12 and IL-23 antagonist, Stelara (ustekinumab), for paediatric patients aged two and above with moderately to severely active Crohn's disease (CD).

Zealand Pharma submits glepaglutide MAA for short bowel syndrome

Zealand Pharma has made a marketing authorisation application (MAA) submission to the European Medicines Agency (EMA) for its long-acting GLP-2 analogue, glepaglutide, to treat adults with short bowel syndrome (SBS).

Bio-Thera and Tabuk partner for Stelara biosimilar in Saudi Arabia

Bio-Thera Solutions has entered into a partnership with Astra Industrial Group subsidiary, Tabuk Pharmaceutical Manufacturing Company, to bring BAT2206, Jansen's Stelara (ustekinumab) biosimilar, to the Saudi Arabian market.

Hong Kong regulator accepts Everest’s ulcerative colitis therapy NDA

The Department of Health of the Hong Kong Special Administrative Region, China, has accepted the new drug application (NDA) for oral VELSIPITY (etrasimod) submitted by Everest Medicines, for treating adults with moderately to severely active ulcerative colitis (UC).

Johnson & Johnson files sBLA for ulcerative colitis treatment

Johnson & Johnson has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) seeking approval for TREMFYA (guselkumab)to treat moderately to severely active ulcerative colitis (UC).

GENESIS and Deciphera enter distribution agreement for Ripretinib

GENESIS Pharma has entered into an exclusive distribution agreement with Deciphera Pharmaceuticals for the marketing of Ripretinib in 14 European Union (EU) markets in Central and Eastern Europe.

Alfasigma to acquire Galapagos’ Jyseleca business

Alfasigma has entered into an agreement to take over the Jyseleca (filgotinib) business of Galapagos.

Palisade Bio receives milestone payment for PALI-2108 development

Biopharmaceutical company Palisade Bio has received a milestone payment from the US Crohn's and Colitis Foundation for the development of its lead programme, PALI-2108.

Everest gets Chinese approval for Xerava to treat cIAI

Biopharmaceutical company Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for its new drug application (NDA) related to Xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI) in adults.