Shots: The approval is based on two clinical trials (P-III FINCH and P-II DARWIN) programs assessing Jyseleca in 3,500+ patients across a range of RA patient populations, including patients new to treatment and those who have demonstrated inadequate response to treatment with SOC including biologic DMARDs. Gilead and Eisai will jointly commercialize Jyseleca across Japan […]Read More
Shots: The CHMP’s positive opinion is based on P-III FINCH and P-II DARWIN programs that included 4,544 RA patient-years of experience with filgotinib. All three FINCH trials involve a broad range of patients that met their 1EPs In the trials, the drug achieved ACR20/50/70 and DAS28(CRP)<2.6. Moreover, Filgotinib inhibited the progression of structural joint damage […]Read More
Shots: Lilly to present results from a long-term study that evaluated the efficacy of Olumiant (4mg, qd) in patients with mod. to sev. RA for 3yrs. of treatment. The study measured LDA as measured by SDAI ≤11, in DMARD-naïve patients and patients with an inadequate response to MTX from treatment initiation to 3yrs. The study […]Read More
Shots: Mycenax to get $5M upfront and will get $16.5M as total deal value in four installments. Richter to get exclusive WW rights to develop, manufacture and commercialize biosimilar tocilizumab The focus of the agreement is to bolster its rheumatology portfolio with addition of Mycenax’s candidate. The biosimilar tocilizumab assets comprise the cell lines, intellectual […]Read More
Shots: The KFDA has approved Celltrion’s Remsima SC for RA while the company is planning to seek approval for IBD within the year through the change permit procedure and is expected to be available to the Korean patients following the completion of the permit for the addition of IBD indications Additionally, Celltrion has filed an […]Read More
Shots: The approval is based on five P-III studies of SELECT program, assessing Rinvoq in ~4,400 patients, including in Brazil The studies resulted in meeting its 1EPs & 2EPs. In SELECT COMPARE study, @12wks, 29% of patients receiving Rinvoq + MTX (methotrexate) achieved remission assessed by the DAS28 – PCR index Rinvoq (PO, qd) is […]Read More
Shots: The filling of NDA is based on P-III FINCH clinical program assessing Filgotinib in 3,452 patients with moderate to severely active RA in people with prior inadequate response to MTX, those who were intolerant to one or more biologic treatments and those who were MTX treatment-naïve The study demonstrated meeting all 1EPs with durable […]Read More
Shots: The approval of RediTrex is done post no. of communications with the FDA and several amendments to the NDA submitted to the FDA in late 2018 Cumberland to launch two injectable methotrexate product lines within the US targeted to treat active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriasis RediTrex (methotrexate) Injection is targeted […]Read More
Shots: The US FDA approval is based on the clinical study assessing Abrilada (adalimumab-afzb) vs reference product, AbbVie’s Humira in 597 biologic-naïve patients with rheumatoid arthritis for 78 wks. Result: @26wks. patients achieved ACR20 (68.7% vs 72.7%) with a treatment difference of −3.98%, ACR20, 50, and 70 rates were similar with both groups The approval […]Read More
Shots: The CHMP positive opinion is based on P-III SELECT program including SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY assessing Rinvoq in 4,400+ patients with mod. to sev. active RA In P-III studies, Rinvoq improved signs and symptoms of RA, inhibited radiographic progression and improved physical function, both as a monothx. and in combination with conventional […]Read More
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