1. Pink Sheet

English HTA OKs AbbVie’s Bispecific Antibody Tepkliny for DLBCL After Initial Refusal

 
• By Francesca Bruce

Patients in England with relapsed or refractory diffuse large B-cell lymphoma will have another treatment option after the health technology appraisal institute NICE recommended AbbVie’s bispecific antibody Tepkinly for funding on the National Health Service . The product is also undergoing a benefit assessment in Germany.

Money and Injection
English HTA decides On AbbVie's subcutaneous bispecific antibody • Source: Shutterstock

NICE, the health technology appraisal (HTA) institute for England and Wales, has recommended AbbVie’s orphan drug Tepkinly (epcoritamab) for treating adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) on the National Health Service in England. New data convinced the institute to issue positive final draft guidance after it initially expressed concerns over uncertainties.

“We are delighted that NICE has recognized the benefit that epcoritamab can have on the lives of people living with R/R DLBCL,” said

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Global Pharma Guidance Tracker - April 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By Cathy Kelly

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.