BC Extra | Dec 30, 2019
Company News

FDA approves Lynparza as first PARP inhibitor for pancreatic cancer

FDA’s approval of Lynparza for pancreatic cancer notches a trio of firsts: the first drug approved for the indication based on PFS rather than OS, the first PARP inhibitor approved to treat the disease, and...
BC Extra | Jun 19, 2019
Company News

June 19 Company Quick Takes: Catalent takes over manufacturing site from BMS; plus Lynparza, Myriad, Amgen and more

Catalent buys Italian facility from BMS  Catalent Inc. (NYSE:CTLT) will buy an Italian manufacturing facility from Bristol-Myers Squibb Co. (NYSE:BMY) for an undisclosed amount. Catalent will manufacture oral solid, biologics and sterile products at the...
BC Week In Review | Feb 28, 2019
Clinical News

Lynparza notches first in POLO trial of pancreatic cancer

AstraZeneca plc (LSE:AZN; NYSE:AZN) and partner Merck & Co. Inc. (NYSE:MRK) announced the first positive data for a targeted agent in a molecularly defined subgroup of patients with metastatic pancreatic cancer. On Feb. 26, the...
BC Innovations | Oct 25, 2018
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...
BC Week In Review | Oct 19, 2018
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...
BC Extra | Oct 16, 2018
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...
BC Week In Review | Jan 19, 2018
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...
BC Extra | Jan 12, 2018
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...
BioCentury | Jan 6, 2018
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...
BC Week In Review | Oct 20, 2017
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...
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