Zeldox QTc Prolongation Is Less Severe Than Serlect, Pfizer Tells Committee

The QTc prolongation associated with Pfizer's antipsychotic Zeldox does not lead to the same clinical events as seen with Abbott/Lundbeck's antipsychotic Serlect, Pfizer told the Psychopharmacological Drugs Advisory Committee July 19.

More from Archive

More from Pink Sheet

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

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.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 

The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.