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Filing & Registration

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March 17, 2023

Sarepta investors fear a panel beating

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March 14, 2023

Amylyx aces launch as tofersen’s big date approaches

Breakeven beckons for Amylyx.

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February 28, 2023

Go or no go? Vaccines and neurology up for discussion

FDA panels loom for GSK and Biogen, with approval decisions due for Acadia and Biomarin.

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January 19, 2023

Sun hopes to make Concert’s alopecia project shine

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December 30, 2022

Regulatory developments over the Christmas period

The FDA and Biogen come in for fierce Congressional criticism, and a handful of new cancer drugs are approved in Japan.

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December 22, 2022

Go or no go? Lecanemab’s destiny approaches

2023 begins with FDA decisions for Eisai’s Alzheimer’s project and Pfizer’s zavegepant, with an adcom for Cidara’s rezafungin.

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November 30, 2022

CTAD 2022 – lecanemab data hold up, with a big but

Keenly awaited results reveal no smoking gun, but lecanemab’s modest activity appears not that different from Aduhelm’s.

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November 30, 2022

Go or no go? Mirati heads to the FDA

TG Therapeutics and Gilead also await a verdict, and Cytokinetics is set for a panel.

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November 08, 2022

AHA 2022 – History repeats for Medtronic

The company’s renal denervation system has failed in a crucial late-stage trial, just as an earlier version did eight years ago.

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November 04, 2022

Apellis delay raises eyebrows, but Iveric cannot celebrate yet

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November 04, 2022

Abeona takes on Amryt – and more importantly, Krystal

Three new epidermolysis bullosa therapies are approaching the US, and expectations vary wildly.

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Latest Reports

February 17, 2023

PD(L)anner – February 2023

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Editor's Picks

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March 13, 2023

Silicon Valley Bank: biopharma’s latest crisis

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March 13, 2023

Pfizer rescues biotech

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February 28, 2023

Why Pfizer (and others) will be interested in Seagen

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March 04, 2023

ACC 2023 – Esperion’s outcomes win looks lacklustre

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March 06, 2023

T-cell receptor behemoths consolidate? Not quite

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