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 a...
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...
07:00 , Oct 17, 2016 |  BC Week In Review  |  Clinical News

Niraparib: Additional Phase III data

Tesaro Inc. (NASDAQ:TSRO), Waltham, Mass.   Zai Lab Ltd., Shanghai, China   Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.   Product: Niraparib (MK-4827)   Business: Cancer   Molecular target: Poly(ADP-ribose) polymerase (PARP)   Description: Oral poly(ADP-ribose) polymerase (PARP) inhibitor   Indication: Treat...
07:00 , Oct 10, 2016 |  BC Extra  |  Clinical News

New data point to broad label for Tesaro's niraparib

Tesaro Inc. (NASDAQ:TSRO) rose $18.64 (19%) to $117.90 on Monday after it revealed full data from the Phase III NOVA study of niraparib ( MK-4827) that could support the candidate's approval to treat ovarian cancer...
07:00 , Jul 11, 2016 |  BC Week In Review  |  Clinical News

Niraparib: Phase III data

Top-line data from the double-blind, international Phase III NOVA trial in about 597 platinum-sensitive ovarian cancer patients who received >=2 prior platinum chemotherapy lines showed that once-daily 300 mg oral niraparib met the primary endpoint...