Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung function and health-related quality of life for children Data reinforce well-established safety profile […]
The European Medicines Agency on March 25 recommended the use of Johnson & Johnson and partner Legend Biotech Corp.’s CAR-T therapy Carvykti to treat multiple myeloma, nearly a month after the treatment was cleared in the United States.
Pfizer Inc. and BioNTech SE said on Jan. 25 they started a clinical trial to test a new version of their vaccine specifically designed to target the COVID-19 Omicron variant, which has eluded some of the protection provided by the original two-dose vaccine regimen.
Belgium’s UCB is acquiring California-based Zogenix, a company focused on rare diseases, in a deal valued up to €1.7 billion ($1.9 billion).
A safety panel of the European drug regulator on January 14 recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s COVID-19 vaccine.
The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
Europe’s medicines regulator added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible rare side effect from Johnson & Johnson’s Covid-19 vaccine after the European Medicines Agency reviewed 108 cases reported worldwide.
Novartis aims to help manufacture more than 50 million doses of BioNTech’s Covid-19 vaccine in 2021 at the Swiss drugmaker’s Stein, Switzerland fill-and-finish facility after the European Union’s drug regulator approved the bottling plant.
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.