US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
Merck announces that it has reallocated Gardasil from the US CDC stockpiles, as a surge in demand sees revenues from the vaccine rise 26% year-on-year.
Bavarian Nordic buys vaccines against rabies and tick-borne encephalitis from GlaxoSmithKline for €301m, with up to €495m more in milestones payments to follow.
Modifications on the regulatory framework and focus on funding schemes are the first steps on the path for healthcare systems to adapt to ATMPs’ ‘new ground’, says ARM head for Europe.
Novartis announces its third quarter results that show Zolgensma is outperforming sales expectations, but company notes approval in EU and Japan pushed back over manufacturing queries.
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
Though the utilization of biosimilars in Europe is high, a report on the practices of eight countries suggests that more can be done to foster competition and remove barriers to entry.
The gene therapy space is a rapidly developing areas in the industry, as a result those with expertise are finding their knowledge is invaluable to companies looking to advance in the space.
