Astellas Pharma, Inc.
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Latest From Astellas Pharma, Inc.
Third Time Is Not A Charm: KEYLYNK-006 Is Latest Keytruda/Lynparza Study To Fail
Merck said the Phase III study of the combination in non-small cell lung cancer did not meet its dual primary endpoint of overall survival and progression-free survival.
Bayer Ready To File Elinzanetant After It Clears Third Phase III Hurdle
Bayer will submit its non-hormonal treatment for vasomotor symptoms associated with menopause for approvals this year, still eyeing €1bn-plus in peak sales despite a rival’s slow start.
Japan Drug Price Revision: Cuts, Increases Aim To Balance National Healthcare Costs
Japan will raise reimbursement prices for selected essential and clinically valuable drugs in April, while cutting back prices for a higher than usual number of other products through the broad application of market expansion repricing rules. The overall regular revision will see prices cut by 4.7% on average.
Quality Officers Call For New Approaches To Reduce Global Manufacturing Change Complexity
Pharmaceutical quality leadership proposes eight-step “dance” with complex global regulatory system for allowing manufacturing processes to improve more quickly. The data showed many authorities take more than the recommended six months to decide on post-approval changes, with assessments taking almost eight years in some cases.
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