Roche’s Hemlibra Looking For CHMP Green Light, Crunch Time for Santhera DMD Hopeful

The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.

Medication
Good news is likely this week in the EU for a clutch of new therapies • Source: Shutterstock

EU regulators will decide this week decide whether several new treatments – including Roche’s hemophilia drug, Hemlibra (emicizumab), which is being fast-tracked through the system – should be recommended for marketing authorization.

Hemlibra is among the eight initial marketing authorizations that the European Medicines Agency’s key advisory panel, the Committee for Medicinal Products for Human Use (CHMP), is considering for an opinion at its January meeting, which kicked off in London on Jan. 22 and runs till Jan. 25. The decisions will be announced on Jan. 26 and forwarded to the European Commission for a binding decision

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

More from Europe

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By 

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

More from Geography

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By 

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.