Otezla

Failed IBD trial dents confidence in BMS’ deucravacitinib

Bristol-Myers Squibb’s hopes of extending the use of its highly-anticipated psoriasis pill deucravacitinib into inflammatory bowel disease (IBD) have been hit by a mid-stage failure in ulcerative colitis. Confidence in the first-in-class tyrosine kinase 2 inhibitor has been riding high after a pair of phase 3 trials hit the mark in psoriasis, setting up regulatory …

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Dermavant raises $200m to ease launch of Otezla rival tapinarof

Dermavant is in line to make some big payments to GlaxoSmithKline if its topical psoriasis drug tapinarof reaches the market, and it has just cut a deal to defray those costs. The Roivant group company has raised $160 million from investors plus a $40 million credit facility that it can draw on if – and …

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Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis

Shots: The acceptance is based on a P-III ADVANCE trial assessing the efficacy of Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis for the first 16wks. All patients then received Otezla during an OLE phase through week 32. Results: @16wks., improvement in its 1EPs of sPGA …

Amgen Reports the US FDA’s Acceptance of sNDA for Review of Otezla (apremilast) to Treat Mild-To-Moderate Plaque Psoriasis Read More »

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots: The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score Otezla is …

Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis Read More »

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.