Drug Approval | March 17, 2022
Lynparza reduced risk of death by 32% in the adjuvant treatment of patients with breast cancer
First PARP inhibitor to demonstrate overall survival benefit in early breast cancer
First PARP inhibitor to demonstrate overall survival benefit in early breast cancer
Career achievement for contributions in Physiologically based pharmacokinetic (PBPK) and biologically based does response (BBDR) modelling tools
This is the sixth successful USFDA audit for this facility
Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial
Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
The audit is a PAI for two of its product applications filed from this facility
The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period
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