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Approvals

AstraZeneca's Imfinzi Scores First Early Lung Cancer Approval

Unlike other indications PD-1/L1 inhibitors are shooting for, Stage III non-small cell lung cancer is an untapped market and AstraZeneca will have the space to itself for a while.
ImmunoOncology Cancer Approvals
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Pipeline Watch: Phase III Starts With Atezolizumab, CNTX-4975 And WTX101

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

EU Delays For Portola As CHMP Trend Votes Go Good And Bad

Portola will have to rein in its European sales ambitions as the CHMP gives early verdicts on its Factor Xa inhibitor betrixaban and its reversal agent andexanet. 

Approvals Policy & Regulation

Think Positive: Clovis Confident Of CHMP Okay For Rubraca

The US biotech expects to finally get its PARP inhibitor for ovarian cancer onto the European market in the next few months to compete with rivals AstraZeneca and Tesaro after the CHMP "communicated a positive trend vote" ahead of an opinion being issued next month.

Cancer Drug Review

Pipeline Watch: Phase III Progress With Avelumab, Ixekizumab And Eravacycline

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Celltrion's Trastuzumab Biosimilar Gets EC Nod

With the latest EC approval, Celltrion's trastuzumab biosimilar Herzuma is set to compete with Samsung's Ontruzant, which received approval late last year.

Commercial Approvals

A First For Prostate Cancer: Janssen's Erleada Approved For Non-Metastatic Patients

J&J subsidiary Janssen's Erleada (apalutamide) is the first therapy approved for non-metastatic castration-resistant prostate cancer (nmCRPC). The US FDA decision came about two months early, but the drug – priced at $10,920 per month, or $131,040 annually – may soon face competition.
Approvals Cancer
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