One of two PARP inhibitors approved in breast cancer, Lynparza may have the adjuvant breast indication all to itself for a while. One analyst projects a $1.5bn revenue opportunity for the indication.
AstraZeneca PLC and partner Merck & Co., Inc. have added a first-in-class indication to PARP inhibitor Lynparza’s (olaparib) US label, making the drug the first approved adjuvant therapy for early, high-risk breast cancer patients with BRCA mutations.
One of two PARP inhibitors approved in breast cancer – along with Pfizer Inc.’s Talzenna (talazoparib) – Lynparza is...
The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.
Coartem Baby to be rolled out in eight African countries in the autumn.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.
The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.
Joshi joins the parent company of Citeline, which houses flagship publications Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.
The UK firm's chronic obstructive pulmonary drug Ohtuvayre has been enjoying a stellar launch.
