Europe tees up Bluebird's first gene therapy approval by Arlene Weintraub Friday, March 29, 2019 The likely EU approval of Bluebird's gene therapy to treat transfusion-dependent β-thalassemia has renewed speculation about pricing.
EMA picks up Xeljanz safety signal, puts Pfizer med under review by Angus Liu Friday, March 1, 2019 The EMA initially rejected Xeljanz's application in 2013 out of safety concerns, only to change its mind in 2017.
Roche yanks Tecentriq kidney cancer apps in U.S., EU by Carly Helfand Tuesday, November 20, 2018 Roche’s I-O rivals are hurtling toward a showdown in kidney cancer. But the Swiss drugmaker has decided to pull its horse out of the race.
Seqirus' cell-based Flucelvax nears first-ever EU approval by Eric Sagonowsky Tuesday, October 23, 2018 While Seqirus works to boost manufacturing for its cell-based flu vaccine in the U.S., the shot is nearing an approval in Europe.
Sanofi's Dengvaxia set for EU approval with CHMP nod by Eric Sagonowsky Friday, October 19, 2018 Sanofi's beleaguered dengue vaccine is expected to win European approval in December following a committee's vote in favor of the shot this week.
CHMP endorses Lilly's CGRP Emgality, Spark's Luxturna and more by Angus Liu Friday, September 21, 2018 Emgality will likely chase Amgen and Novartis’ first-in-class Aimovig and Teva's Ajovy in the CGRP migraine field.
European Keytruda backing rubs salt in BMS' wounds by Carly Helfand Monday, July 30, 2018 Merck’s Keytruda is one step closer to extending its dominance in the all-important previously untreated lung cancer market.
Gilead, Novartis CAR-T drugs score CHMP backing by Eric Sagonowsky Friday, June 29, 2018 Gilead and Novartis CAR-T cancer drugs Yescarta and Kymriah won an EMA committee backing for marketing approval.
Sanofi’s first product from the Ablynx deal wins CHMP backing by Angus Liu Friday, June 29, 2018 Analysts previously predicted Cablivi (caplacizumab) could be the standard of care for aTTP, with peak global sales at $500 million.
GSK's Juluca, Amgen's Repatha and more score EU backing by Carly Helfand Friday, March 23, 2018 Thursday was a busy day for Europe’s regulators—and their whirl of activity will send several drugmakers into the weekend happy.
