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Amylyx changes its mind about an early filing
The group hopes phase 2 data will back approval for its amyotrophic lateral sclerosis project AMX0035 after all.
Breakthrough device reimbursement rule on the rocks
Despite industry outcry, new data question how relevant the rule would have been anyway.
Astellas readies roxadustat for launch
But winning EU approval for the novel anaemia pill was not straightforward, the Japanese firm says.
Medtech
Breakthrough device reimbursement rule on the rocks
Despite industry outcry, new data question how relevant the rule would have been anyway.
Company Events
Go or no go? A first for Nefecon
Calliditas is hoping for its first approval, while Abbvie is gearing up to enter the crowded migraine space with an oral anti-CGRP project.
Nektar again looks to bempeg to sweeten its valuation
The depressed company’s bempegaldesleukin, which underwhelmed in melanoma, now faces two key near-term clinical data readouts.
Mirati fiddles as its share price burns
Speedy US approval for Amgen’s Lumakras was an embarrassment for Mirati, which has gone quiet as its share price has drifted downwards.
Interviews
Amylyx changes its mind about an early filing
The group hopes phase 2 data will back approval for its amyotrophic lateral sclerosis project AMX0035 after all.
Astellas readies roxadustat for launch
But winning EU approval for the novel anaemia pill was not straightforward, the Japanese firm says.
