Other Hematology/Oncology – key highlights
Momentum is strong behind the U.S. launch of Monjuvi (tafasitamab-cxix), with good uptake in both academic and community settings and illustrated by the market share gained in the first several months since launch.
The Phase 3 inMIND trial evaluating tafasitamab plus lenalidomide and rituximab (R-squared) versus R-squared in patients with relapsed or refractory follicular or marginal zone lymphoma is open for recruitment, and the Phase 3 frontMIND trial of tafasitamab plus lenalidomide and R-CHOP versus R-CHOP as a first-line treatment in patients with DLBCL is expected to open in the coming months.
The U.S. launch of Pemazyre (pemigatinib) has been successful and, in January, Incyte announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally
Search jobs 10-Feb-2021 Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn’s Disease
Takeda Submits New Drug Application to Manufacture and Market Darvadstrocel
In Japan for Treatment of Complex Perianal Fistulas in Adult Patients with Crohn’s Disease
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Who Do Not Respond to Conventional or Biologic Therapies for Complex Perianal Fistulas in Crohn’s Disease[i]
Osaka, JAPAN, February 10, 2021 –Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD).
Protalix BioTherapeutics and Chiesi Global Rare Diseases Present Key Clinical Data of Pegunigalsidase Alfa for the Treatment of Fabry Disease at the 17th Annual WORLDSymposium™ 2021
USA - English
Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy
Mean overall annualized change in estimated Glomerular Filtration Rate (eGFR slope) improved from -5.9 to -1.2 mL/min/1.73 m2/year
12-months on-treatment Phase III BRIDGE study final results suggest a potential benefit of pegunigalsidase alfa on renal function for Fabry patients who were previously treated with agalsidase alfa
The number of patients with moderately progressing or fast progressing kidney disease decreased and the majority of patients achieved a stable kidney disease status post-switch
Press release content from Business Wire. The AP news staff was not involved in its creation.
Exelixis Announces Positive Findings at ASCO GU for CABOMETYX® (cabozantinib) in Patients with Brain Metastases from Renal Cell Carcinoma
February 8, 2021 GMT
ALAMEDA, Calif. (BUSINESS WIRE) Feb 8, 2021
Exelixis, Inc. (NASDAQ: EXEL) today announced results from a retrospective analysis evaluating CABOMETYX ® (cabozantinib) activity in brain metastases in patients with renal cell carcinoma (RCC). The findings will be presented as part of the Poster Session: Renal Cell Cancer at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), which is being held virtually, February 11-13, 2021. All posters will be available on demand beginning at 5:00 a.m. PT on Thursday, February 11.
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