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Novartis AG

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Latest From Novartis AG

Zolgensma Fall-Out: Is Threat To Novartis – Or US FDA Climate Overall?

FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.

Legislation Compliance

AstraZeneca Buys Priority Review Voucher With Two Big Filings On The Horizon

AstraZeneca paid $95m to Swedish Orphan Biovitrum for the voucher, which it could use to expedite the FDA review of roxadustat or trastuzumab deruxtecan.

Drug Review Launches

Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation

Glenmark appears close to sewing up a deal for its biosimilar version of Novartis/Genentech's Xolair amid the firm's ongoing focus on partnering out some key assets. It also expects to kick off plans to raise capital in the US for its innovation business in Q4 of fiscal 2019-20.

Commercial Strategy

2018 Completed Clinical Trials: Change Is The New Constant

Trialtrove’s annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, while there are patterns of consistency in many aspects of the trial landscape, changes are in the wind – particularly as companies outside the pharma top 20 now contribute more completed trials than any other type of sponsor.

Clinical Trials Market Intelligence
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