BC Extra | Sep 17, 2019
Company News

Sept. 17 Company Quick Takes: Priority Review for Merck Ebola vaccine; plus Edgewise’s debut, Adaptive, AskBio and Acceleron

Merck Ebola vaccine granted Priority Review  FDA accepted and granted Priority Review to a BLA from Merck & Co. Inc. (NYSE:MRK) for its Ebola vaccine V920 (rVSV-ZEBOV). The candidate has a PDUFA date of March...
BC Extra | Aug 2, 2019
Company News

Aug. 1 Company Quick Takes: Nektar gains on breakthrough for NKTR-214; plus Adaptive's MRD test, Acadia, Vanda and more

Nektar gains after FDA breakthrough therapy designation  Nektar Therapeutics Inc. (NASDAQ:NKTR) was up $2.73 (10%) to $31.19 after FDA granted breakthrough designation for bempegaldesleukin (NKTR-214) in combination with Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY)...
BC Extra | Jul 31, 2019
Company News

July 31 Company Quick Takes: Bayer, Orion win approval in prostate cancer; plus Keytruda, Roche-Spark, UC v. Broad and more

Bayer, Orion androgen receptor inhibitor approved for prostate cancer  FDA approved an NDA for Nubeqa darolutamide from Bayer AG (Xetra:BAYN) and Orion Corp. (HSE:ORNAV; HSE:ORNBV) to treat non-metastatic castration-resistant prostate cancer. The oral androgen receptor...
BC Extra | Oct 15, 2018
Politics & Policy

FDA guides on minimal residual disease endpoint in hematologic cancer trials

FDA Commissioner Scott Gottlieb highlighted minimal residual disease (MRD)'s potential as a surrogate endpoint in clinical trials when he unveiled FDA's draft guidance on using MRD in hematologic malignancy drug development in a statement Monday....
BC Week In Review | Oct 5, 2018
Clinical News

FDA approves minimal residual disease diagnostic

FDA approved clonoSEQ Assay from Adaptive Biotechnologies Corp. (Seattle, Wash.) to detect minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). The agency said clonoSEQ Assay is the first...
BC Extra | Sep 28, 2018
Company News

FDA approves minimal residual disease diagnostic

FDA approved clonoSEQ Assay from Adaptive Biotechnologies Corp. (Seattle, Wash.) to detect minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma (MM). The agency said clonoSEQ Assay is the first...
BC Week In Review | May 25, 2015
Company News

Multiple Myeloma Research Foundation (MMRF), Amgen, Adaptive Biotechnologies, University of Turin deal

The partners will perform sequencing-based assessment of minimal residual disease (MRD) on more than 400 patients with multiple myeloma (MM) enrolled in the open-label Phase II INSIDE MM-1 trial of Kyprolis carfilzomib from Amgen and...
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