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Fines & Regulatory Issues

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March 29, 2021

Uniqure tries to restore gene therapy calm

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January 20, 2021

Glaxo joins the Covid-19 delay queue

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January 15, 2021

The biotech resurrection continues

Positive surprises with Lexicon’s Zynquista and DBV’s Viaskin Peanut show that you can never entirely write biotech off.

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October 07, 2020

Thinking the unthinkable on Covid vaccine approvals

With the EU regulator already reviewing two coronavirus vaccines, could it beat the US FDA to the punch?

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August 04, 2020

DBV confirms the inevitable

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May 18, 2020

Covid-19 excitement masks Sorrento’s disastrous capital structure

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March 17, 2020

Crisis, what crisis? Curevac denies everything

As a Covid-19 vaccine exclusivity and senior management storm engulfs Curevac, the German mRNA specialist insists it’s just conjecture and coincidence.

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January 22, 2020

Internal FDA documents reveal a familiar story for Sarepta

The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.

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August 22, 2019

Astra could use a voucher to cement roxadustat’s head start

Spending $95m to speed up the anaemia project’s path to approval could be worth the investment for Astrazeneca.

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August 02, 2019

A recap on the past few months of data digging and analysis

Using EvaluatePharma data Vantage explored investment trends in biopharma and medtech, sales per employee at big drug makers, and the declining number of late-stage…

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July 11, 2019

Indivior fights off generic challenges but the threat of litigation remains

Weaker than expected generic erosion of its key Suboxone film product has allowed Indivior to raise full-year guidance.

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