BioCentury | Dec 30, 2019
Company News

FDA approves Lynparza as first PARP inhibitor for pancreatic cancer

...pancreatic cancer in patients who have not progressed on platinum chemotherapy. The agency also approved BRACAnalysis CDx...
BioCentury | Feb 28, 2019
Clinical News

Lynparza notches first in POLO trial of pancreatic cancer

...breast cancer. Myriad Genetics Inc. (NASDAQ:MYGN) also said it will seek FDA approval of its BRACAnalysis CDx...
...said the test successfully identified BRCA-positive patients in POLO who benefited from treatment with Lynparza. BRACAnalysis CDx...
BioCentury | Oct 25, 2018
Translation in Brief

Classifying BRCA1 mutations

...to a subset of variants in one gene, which limits clinical applicability. Myriad markets the BRACAnalysis CDx...
BioCentury | Oct 19, 2018
Clinical News

After three deals, FDA approval, talazoparib joins PARP party

...the indication. The approval comes well ahead of Talzenna's December PDUFA date. FDA concurrently approved BRACAnalysis CDx...
...with chemotherapy. Lynparza has a WAC of $13,886.46 per month, or $166,637.52 per year. Myriad's BRACAnalysis CDx...
...New York, N.Y. Product: Talzenna talazoparib Business: Cancer Elizabeth S. Eaton talazoparib (MDV3800, bmn 673, bmn-673, lt-673) Tumor BRACAnalysis CDx (BRACAnalysis CDx) BioMarin...
BioCentury | Oct 16, 2018
Company News

After three deals, FDA approval talazoparib joins PARP party

...the indication. The approval comes well ahead of Talzenna's December PDUFA date. FDA concurrently approved BRACAnalysis CDx...
...with chemotherapy. Lynparza has a WAC of $13,886.46 per month, or $166,637.52 per year. Myriad's BRACAnalysis CDx...
BioCentury | Jan 19, 2018
Clinical News

FDA approves AZ's Lynparza for breast cancer

...of discontinuations in the chemotherapy arm. Concurrent with Lynparza's approval, FDA approved Lynparza's companion diagnostic BRACAnalysis CDx...
...U.K. Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Lynparza olaparib (AZD2281, KU-0059436) Business: Cancer Allison Johnson BRACAnalysis CDx talazoparib veliparib Zejula AbbVie...
BioCentury | Jan 12, 2018
Company News

FDA approves AZ's PARP inhibitor for breast cancer

...number of discontinuations in the chemotherapy arm. Also on Friday, FDA approved Lynparza's companion diagnostic BRACAnalysis CDx...
...onset (BRCA1) and BRCA2 genes from whole blood. Myriad gained $0.52 to $36.05 on Friday. Allison Johnson BRACAnalysis CDx talazoparib veliparib Zejula AbbVie...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...Keytruda pembrolizumab Primary mediastinal B cell lymphoma (PMBCL) PDUFA date 4/3/18 Myriad Genetics Inc. (NASDAQ:MYGN) BRACAnalysis CDx...
BioCentury | Oct 20, 2017
Clinical News

AZ's Lynparza gets Priority Review for breast cancer

...to treat ovarian cancer. Concurrently, FDA accepted for review an sPMA for Lynparza companion diagnostic BRACAnalysis CDx...
...& Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Lynparza olaparib ( AZD2281 , KU-0059436) Business: Cancer Allison Johnson BRACAnalysis CDx Lynparza Olaparib AstraZeneca...
BioCentury | Oct 18, 2017
Company News

Priority Review for Lynparza to treat breast cancer

...approved to treat ovarian cancer. Concurrently, FDA accepted for review an sPMA for companion diagnostic BRACAnalysis CDx...
...onset (BRCA1) and BRCA2 genes from whole blood. Myriad slipped $1.40 to $34.44 on Wednesday. Allison Johnson BRACAnalysis CDx Lynparza niraparib Olaparib veliparib AbbVie...
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