th Annual Meeting of the EBMT
ZUG, Switzerland
15 March, 2021 bluebird bio, Inc. (Nasdaq: BLUE) announced new data from the clinical development programme for its investigational elivaldogene autotemcel (eli-cel, Lenti-D™) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including updated results from the pivotal Phase 2/3 Starbeam study (ALD-102) and the long-term follow-up study LTF-304, as well as safety outcomes from the Phase 3 ALD-104 study. These data were presented today in an oral presentation during the Presidential Symposium at the 47
th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2021), taking place virtually from March 14–17, 2021.
“The progression of CALD may occur rapidly, leading to severe neurological decline, and often death, of boys with this disease. The results presented today show that at 24 months of follow-up, 90% of patients (27/30) in our pivotal study of eli-cel (ALD-102) were ali
Redirecting to Subgroup Analysis from Phase 3 Clinical Trial Supports Efficacy of Maribavir Over Conventional Therapies in Transplant Recipients With Cytomegalovirus Infection (Refractory, With or Without Resistance)
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Ipsen Receives Positive CHMP Opinion Recommending Cabometyx in Combination With Opdivo as First-line Treatment for Patients Living With Advanced Renal Cell Carcinoma
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Patients treated with Cabometyx in combination with Opdivo reported significantly better health-related quality of life and a lower rate of discontinuation versus sunitinib
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Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Cabometyx (cabozantinib) in combination with Bristol Myers Squibb s Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). The European Commission, which has the authority to approve medicines for the European Union (E.U.), will now review the CHMP recommendation and a final decision on the application in the E.U. is expected in the coming months.
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THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.
The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.
Psyence Group Completes First Cultivation Cycle of Medical Psilocybin Mushrooms at Its Commercially Licensed Facility
TORONTO, Jan. 29, 2021
Psyence Group Inc. (“Psyence” or the “Company”) is pleased to announce that it has concluded its first cultivation and harvest cycle of natural medical psilocybin mushrooms. The mushrooms were grown, harvested, processed, and packed at its premium production facility in Lesotho which has been designed and built to the highest international standards.
Jody Aufrichtig, Chief Executive Officer and Director of Psyence commented: “
This is an important milestone in Psyence’s journey to becoming one of the first federally licensed producers of high quality, medicinal-grade mushrooms for the legal medical and research markets. Market research has shown that there is a significant shortage of Good Manufacturing Practice certified and legally produced psilocybin products and we are able to supply and service the global research marke
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