ExeGi Pharma gets FDA orphan drug status for EXE-346 in pouchitis
ExeGi Pharma said that EXE-346 has been granted an orphan drug designation from the US Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. EXE-346 is a live biotherapeutic (LBP) that contains a fixed-proportion of eight strains of live probiotic bacteria which are intended to be administered orally. Pouchitis is a […]
Seres Therapeutics begins phase 1b trial of SER-301 in ulcerative colitis
November 8, 2020 No Comment
Seres Therapeutics has dosed the first patient in a phase 1b clinical trial, which is assessing SER-301 for the treatment of active mild-to-moderate ulcerative colitis (UC). According to the US-based biotech company, SER-301 is an oral fermented microbiome therapeutic designed for dampening the unusual gastrointestinal inflammation central to ulcerative colitis and promote clinical remission in […]
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Bristol Myers Squibb (BMS) said that the phase 3 True North clinical trial evaluating Zeposia (ozanimod) in adult patients with moderate to severe ulcerative colitis (UC) met both primary endpoints. The placebo-controlled late stage trial featuring 645 patients assessed oral Zeposia as an induction and maintenance therapy for the chronic inflammatory bowel disease (IBD). ZEPOSIA […]
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Allergan has agreed to sell IL-23 inhibitor brazikumab to AstraZeneca and gastrointestinal medication Zenpep (pancrelipase) to Nestle in separate agreements, as per the latest pharma acquisition news. Financial details of the two deals have not been disclosed. The divestments are being taken up in an effort to wrap up the $63 billion AbbVie acquisition of […]
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Stelara FDA approval for ulcerative colitis treatment : The Janssen Pharmaceutical Companies of Johnson & Johnson has bagged approval from the US Food and Drug Administration (FDA) for Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis. Considered to be a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, […]
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Landos Biopharma, a US clinical-stage pharma company focused on the discovery and development of oral therapeutics for autoimmune diseases, has closed a $60 million Series B financing round. The financing round was co-led by RTW Investments and Perceptive Advisors (Perceptive Xontogeny Venture Fund and Perceptive Life Sciences Fund). Osage University Partners and PBM Capital were […]
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Israeli pharma company Teva Pharmaceuticals has launched a generic version of Delzicol (mesalamine) 400mg delayed-release capsules in the US. Mesalamine Delayed-Release capsules are an aminosalicylate, approved for the treatment of mild to moderate ulcerative colitis in patients aged five years and above, and also for maintenance of remission of ulcerative colitis in adult patients. Brendan […]
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Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). ABP 710 is being studied as a biosimilar candidate to infliximab, which is an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab has approval in several regions […]
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Hyrimoz EC approval : Novartis’ Sandoz has bagged approval for Hyrimoz (adalimumab), a biosimilar of AbbVie’s Humira (adalimumab), in Europe for all indications of the reference drug including rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis and ulcerative colitis. The approval of Hyrimoz by European Commission (EC) was driven by analytical, preclinical and clinical research that […]
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