U.S. FDA has approved a new indication for Japan-based Eisai's Aloxi (palonosetron hydrochloride) for post-operative nausea and vomiting in the first 24 hours after surgery. The drug maker announced approval of the expanded indication March 3 for the drug it obtained through the acquisition of MGI Pharma earlier this year (PharmAsia News, Jan. 24, 2008).
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Celltrion is set to acquire a US biologics manufacturing facility that will "eliminate" its US tariff risks and provide a ready-made production base for future expansion.
PAH drug Winrevair generated more than $1bn in sales in its first year on the US market, but the company plans to cut $3bn in costs through 2027 that it will reinvest in additional growth drivers.
PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.
