
CHMP recommends OK for Alnylam's patisiran; Amgen scraps a BCMA ADC
→ Alnylam $ALNY took another big step toward getting a European approval for patisiran. The biotech says that the CHMP recommended an OK for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. A formal OK is likely. The drug is facing an August 11 PDUFA date at the FDA.
→ Portola $PTLA, though, isn’t making any headway with betrixaban. The CHMP batted back the company’s appeal of its earlier rejection. Here’s a summary of all the action at the EMA today.
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