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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...

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More from Europe

Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

Denmark Introduces First Confidential Pricing Framework For Primary Care Medicines

 
• By Francesca Bruce

Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

More from Geography

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.