Phase-III tests indicate patients may be able to switch from injectable enzyme-replacement therapies, like Fabrazyme, to the firm’s oral drug.
A $225-million deal with US biotech ArmaGen gives Shire worldwide commercialization rights to an experimental enzyme replacement therapy.
An advocacy group alleges that Shire’s decision to ignore the US Fabry disease market was the result of a backroom deal with Sanofi.
Analyst reaction to this week’s quarterly news reflected a need to woo investors, adding to some negative carryover from the previous year.
The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.
The Thousand Oaks, Calif. company says its cholesterol-lowering antibody hit its clinical trial endpoint among rare disease patients.
The UK watchdog wants to know what’s behind the rare-disease drug’s high price.
Kynamro’s slow start, coupled with competition, has prompted Sanofi to add sales reps.
Regulatory Focus discusses how the expanding US population may make it harder for a condition to qualify as rare.
The FDA granted priority review for the experimental, all-oral Gaucher’s disease treatment.
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