16:04 , Oct 25, 2018 |  BC Innovations  |  Translation in Brief

Classifying BRCA1 mutations

University of Washington researchers have characterized the clinical consequences of nearly 4,000 variants in the tumor suppressor gene BRCA1 using saturation genome editing. The results provide interpretation of variants with previously uncertain significance and will...
18:10 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

After three deals, FDA approval, talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
22:50 , Oct 16, 2018 |  BC Extra  |  Company News

After three deals, FDA approval talazoparib joins PARP party

FDA approved Talzenna talazoparib from Pfizer Inc. (NYSE:PFE) to treat germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, making it the second PARP inhibitor approved for the indication. The approval comes well ahead of...
06:22 , Jan 19, 2018 |  BC Week In Review  |  Clinical News

FDA approves AZ's Lynparza for breast cancer

FDA approved an sNDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) for ovarian cancer drug Lynparza olaparib to treat patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously...
20:19 , Jan 12, 2018 |  BC Extra  |  Company News

FDA approves AZ's PARP inhibitor for breast cancer

FDA approved an sNDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) for ovarian cancer drug Lynparza olaparib to treat patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
00:29 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

AZ's Lynparza gets Priority Review for breast cancer

FDA accepted and granted Priority Review to an sNDA for Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) to treat patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who...
23:07 , Oct 18, 2017 |  BC Extra  |  Company News

Priority Review for Lynparza to treat breast cancer

FDA granted Priority Review to an sNDA for Lynparza olaparib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) to treat patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have previously...
23:13 , Apr 13, 2017 |  BC Week In Review  |  Company News

Myriad, BeiGene deal

BeiGene and Myriad Genetics will develop a companion diagnostic to support development of BeiGene's BGB-290 using Myriad's myChoice Homologous Recombination Deficiency (HRD) and BRACAnalysis CDx tests. BGB-290, a PARP-1 and PARP-2 inhibitor, is in multiple...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Lynparza olaparib: Phase III data

Top-line data from the double-blind, international Phase III SOLO-2 trial in 295 patients with platinum-sensitive, relapsed or recurrent BRCA-mutant ovarian cancer showed that maintenance treatment with twice-daily 300 mg oral Lynparza met the primary endpoint...