1. Scrip
  2. >>New Products

EU Ultomiris Approval Rounds Off A Good Week For Alexion’s Complement Franchise

 
• By Alexandra Shimmings

A first EU approval for Ultomiris added to a label expansion for Soliris in the US made for a good seven days for Alexion’s C5 product portfolio.

Toast
celebrate good times • Source: Shutterstock

The European Commission has approved Alexion Pharmaceuticals Inc.’s Soliris successor, Ultomiris, for its first indication, paroxysmal nocturnal hemoglobinuria, just days after the US Food and Drug Administration approved Soliris for its fourth indication, neuromyelitis optica spectrum disorder (NMOSD).

In April, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Ultomiris (ravulizumab) for the treatment of adult patients with PNH with hemolysis and clinical symptoms indicative...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: 12 Approvals And 26 Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

More from Scrip

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Novo Nordisk’s CEO forced out; quantifying biopharma’s contribution to the US economy; a history of MASH deals; lift for AstraZeneca’s asthma ambitions; and major Japanese firms see US revenue growth.

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By Xu Hu

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

Tech Convergence, Quality Data Needed To Accelerate Korea’s AI-Powered R&D

 
• By Jung Won Shin

AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.