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Aurinia Pharmaceuticals Inc.

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Latest From Aurinia Pharmaceuticals Inc.

Pfizer’s Talzenna Takes On Top Dog Lynparza In Prostate Cancer

Top-line Phase III results for Talzenna/Xtandi showed improved PFS in mCRPC patients regardless of HRR mutation status, where AstraZeneca/Merck have developed fellow PARP inhibitor Lynparza.

Clinical Trials Business Strategies

Stock Watch: Digging Holes And Clutching At Straws In Biotech R&D

Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.

Stock Watch Complete Response Letters

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

Clinical Trials Cancer

Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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