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FDA grants priority review to AstraZeneca, Merck & Co.'s filing for Lynparza in first-line maintenance setting for ovarian cancer
firstwordpharma
November 13, 2018
AstraZeneca and Merck & Co. said Monday that the FDA granted priority review to a filing seeking approval of Lynparza (olaparib) as a maintenance treatment for patients with newly diagnosed, BRCA-mutated advanced ovarian cancer who are in complete or part
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AstraZeneca, Merck's Lynparza scores speedy review in blockbuster ovarian cancer market
fiercepharma
November 13, 2018
Last month, AstraZeneca and Merck’s Lynparza posted big-time ovarian cancer data, and regulators are taking note.
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NICE says no to expanding use of AZ’ Lynparza
pharmatimes
November 12, 2018
The National Institute for Health and Care Excellence has ruled against expanding use of AstraZeneca’s Lynparza to a wider patient population with ovarian cancer.
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AZ and MSD’s Lynparza shows significant results in ovarian cancer
pharmatimes
October 25, 2018
AstraZeneca and MSD’s Lynparza improved progression-free survival by 70% compared to placebo in BRCA-mutated ovarian cancer patients who were in complete or partial response...
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Carrick bags ex-Onyx cancer drug, plans pivotal trials
fiercebiotech
October 12, 2018
Carrick revealed details of the licensing agreement alongside news that it has appointed George Golumbeski as chairman.
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Evidence mounts linking aspirin to lower risk of ovarian cancer
worldpharmanews
October 08, 2018
Taking a low-dose aspirin daily may help women lower their risk of developing ovarian cancer.
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Glythera rebrands as Iksuda, pledging to solve ADC problems
fiercebiotech
September 11, 2018
Despite their promise, antibody-drug conjugates (ADCs) have been tricky to bring to market, but the U.K. biotech formerly known as Glythera wants to change that.
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EU reviews first PARP inhibitor for breast cancer
pharmatimes
July 18, 2018
MSD and AstraZeneca’s Lynparza will be the first PARP inhibitor to be reviewed in Europe for the treatment of breast cancer, after the European Medicines Agency validated the drug’s marketing application in this setting.
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Clovis’ PARP inhibitor Rubraca under EU review in maintenance setting
pharmatimes
July 10, 2018
European regulators have agreed to review Clovis’ application to expand the use of its PARP inhibitor Rubraca in the region.
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EU regulators widen Lynparza’s reach
pharmatimes
July 09, 2018
European regulators have approved a tablet formulation and new dosing regimen for AstraZeneca and MSD’s Lynparza to treat a wider range of patients with ovarian cancer.