Merck has agreed to acquire Pandion Therapeutics, a Massachusetts-based clinical-stage biotech company, for about $1.85 billion in an all-cash deal. Pandion Therapeutics is engaged in developing therapeutics for addressing the unmet needs of patients suffering from autoimmune diseases. The US biotech company is being acquired by Merck for $60 per share. Commenting on Merck acquisition […]
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 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 […]
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 […]
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 […]
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, […]
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 […]
Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). This submission marks a significant milestone in Amgen’s efforts to expand its biosimilar portfolio. ABP 710: A Biosimilar to Infliximab ABP 710 is being developed […]
In a significant advancement for biopharmaceuticals, Novartis’ division Sandoz has secured approval from the European Commission (EC) for Hyrimoz (adalimumab), a biosimilar to AbbVie’s Humira. This approval encompasses all indications of the reference drug, including treatment for rheumatoid arthritis, Crohn’s disease, plaque psoriasis, uveitis, and ulcerative colitis, marking a pivotal step in broadening access to […]