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Approvals

Sanofi/Regeneron Choose Access Over Price With Dupixent Launch

The FDA approved the IL-4/IL-13 inhibitor March 28 in a win for Sanofi and Regeneron. The companies set the biologic's price at $37,000 per year, which is lower than many biologics on the market for psoriasis.

Launches Approvals Pricing Strategies
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Broad Label Gives Tesaro's Niraparib A Head Start In Ovarian Cancer

Tesaro takes opportunity of broad approval for Zejula (niraparib) in recurrent ovarian cancer to highlight franchise expansion opportunities in other tumor types, including PD-1 inhibitor combination studies.

Approvals Clinical Trials

Purdue Highlights Convenience Of New Opioid Induced Constipation Drug Symproic

With oral naldemedine joining Purdue's pain portfolio, the company will look for ways to foster communication between patients and doctors about treatment for opioid-induced constipation.

Approvals Clinical Trials

CHMP Opinions: Opdivo Sees Keytruda's Hodgkin's And Raises It Head & Neck

Merck & Co and Bristol Myers Squibb's rival anti-PD1 products continue their game of one-upmanship with each gaining a new indication in the latest round of EU CHMP opinions.

Approvals Drug Review

Pipeline Watch: Phase III Data For Abemaciclib, JZP-110 And NKTR-181

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

Pfizer's Avelumab Makes Its Debut, In Rare Form Of Skin Cancer

Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.

Approvals ImmunoOncology

Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month

First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.

Approvals Regulation
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