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Priority Review

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April 14, 2022

Is biopharma getting better at accelerated approval conversions?

Amid ongoing pressure to reform the FDA’s fast-track pathway, signs emerge that the criticism is being heard.

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June 24, 2021

Lilly rushes through wide-open US Alzheimer’s floodgates

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January 18, 2021

Aducanumab tops 2021’s biggest potential launches

Blockbuster sales are predicted for several projects nearing approval, from Biogen, Argenx, Fibrogen and others.

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May 06, 2020

The Celgene contingent value right comes down to the wire

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March 27, 2020

Holding a contingent value right in uncertain times

Though the stage is apparently set for Bristol’s contingent value right to pay out, the instrument trades at depressed levels.

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February 18, 2020

FDA keeps the faith in surrogate endpoints

The US regulator granted 14 accelerated approvals in 2019, fewer than in the previous two years, and the sector remains slow at conversions.

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February 17, 2020

Solving the mystery of Vifor’s new voucher

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November 16, 2018

Upcoming events – Vertex awaits triplet data and GBT seeks approval for approval

Vertex is due the first pivotal data on its cystic fibrosis triplets, while Global Blood Therapeutics will soon find out whether it can take a shortcut on voxelotor’s…

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August 01, 2018

Pharma’s fastest followers revealed

Analysis of me-too drug approvals over time shows trends across therapy areas.

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July 27, 2018

Upcoming events – FDA decisions loom for Alnylam and Pfizer

The companies hope that the US regulator approves patisiran and lorlatinib.

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July 17, 2018

Roche tries again with a new pill for flu

A new influenza antiviral from Roche and Shionogi could become an important new medicine for both groups, if payers can be convinced.

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