Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Theravance Biopharma Inc.’s phase IIb fizzle with izencitinib in ulcerative colitis (UC) put a dent in shares, as Wall Street mulled the ongoing phase II study in Crohn’s disease (CD) as well as prospects regarding the deal with Johnson & Johnson.
DUBLIN – Abivax SA has started planning for a pivotal phase III program for its inflammatory bowel disease drug candidate, ABX-464, following a readout of top-line data from a phase IIb induction study in ulcerative colitis, in which the molecule attained the primary endpoint at all three dose levels tested. It demonstrated efficacy on a range of secondary endpoints, too, while its safety profile also appeared to be favorable.
Shanghai and New Jersey-based Lianbio Co. Ltd. has made its second in-licensing deal in a week. This time, it obtained rights for omilancor and NX-13, both under development by Landos Biopharma Inc. for the potential treatment of ulcerative colitis (UC) and Crohn’s disease (CD) – plus eosinophilic esophagitis, for omilancor – in greater China, South Korea and seven ASEAN countries as part of a $218 million deal.
Shanghai and New Jersey-based Lianbio Co. Ltd. has made its second in-licensing deal in a week. This time, it obtained rights for omilancor and NX-13, both under development by Landos Biopharma Inc. for the potential treatment of ulcerative colitis (UC) and Crohn’s disease (CD) – plus eosinophilic esophagitis, for omilancor – in greater China, South Korea and seven ASEAN countries as part of a $218 million deal.
HONG KONG –Celltrion Group is partnering with Intract Pharma Ltd. to jointly develop an oral tablet form of infliximab. “Celltrion will supply the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies,” Bill Lindsay, the CEO of Intract, told BioWorld.
LONDON – Enterome SA has raised €46.3 million (US$52.6 million) in a mixture of debt and equity, enabling it to take a new type of cancer vaccine, based on microbiome-derived antigens that mimic neoantigens expressed on tumor cells, into the clinic.
Despite Provention Bio Inc.'s phase IIa top-line data showing PRV-6527 in Crohn's disease did not differentiate from placebo, the company's stock was bumped back less than 1% on Tuesday as it continued to ride high after June's massive leap on heartening data about the company's type 1 diabetes trial of teplizumab.
