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EU Decision Time For Teclistamab & Seven Other Drugs; Incyte Withdraws Parsaclisib Filing

 
• By Neena Brizmohun

Janssen’s bispecific antibody, teclistamab, and Eli Lilly’s potential blockbuster diabetes drug, tirzepatide, are among the products that are this week up for an opinion by the European Medicines Agency on whether they should be approved in the EU.

Question marks background. High resolution 3d render
Companies may soon learn if their drugs will be recommended for EU approval • Source: Alamy

 The European Medicines Agency is this week set to decide whether to recommend pan-EU marketing authorization for eight new products including teclistamab, Janssen Pharmaceutical’s investigational orphan drug for treating relapsed or refractory multiple myeloma (RRMM).

Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 that during its development was accepted onto the PRIME scheme, the EMA’s initiative for

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More from Europe

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

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

 
• By Francesca Bruce

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 Vibha Sharma

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

More from Geography

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

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.