Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]Read More
Shots: Imcyse to receive up front, ~$180M as milestones along with royalties. Pfizer to purchase an equity stake in Imcyse Initially, the companies will collaborate to develop existing lead candidates and further optimize potential molecules. Later, Pfizer will lead clinical development and commercialization activities for the program The Imotope platform is a curative approach to […]Read More
Shots: The Health Canada has granted a NOC which is based on clinical evidence for Remsima/CT-P13 SC vs CT-P13 IV up to 1year in patients with RA. The results demonstrated that switching patients from Remsima IV to its SC formulation @30wks. is comparable to maintaining Remsima SC up to 54wks. The therapy has shown similar […]Read More
Shots: The post marketing Oral Surveillance involves assessing the safety of tofacitinib at two doses (5 mg, bid and 10mg, bid) vs TNFi in 4362 patients in subjects with RA aged ≥ 50yrs. and had at least one additional CV risk factor The primary analyses include 135 subjects with MACE and 164 subjects with malignancies. […]Read More
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
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