Although the CRL delayed the cell therapy’s approval by almost two years, additional CMC-related testing requested by the FDA ultimately came to be seen as a good thing by sponsor CellTrans because it provided assurance of product consistency.
Product quality issues that led to a nearly two-year delay in approval of CellTrans, Inc.’s Lantidra (donislecel-jujn) for type 1 diabetes reflect the challenges small sponsors of novel and complex biological therapies face in getting their manufacturing programs ready to satisfy regulatory expectations.
Donislecel, a cellular therapy product containing purified allogeneic deceased donor pancreas derived islets of Langerhans for transplant, gained a favorable...
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.
Manufacturers likely will have to determine when to provide a 340B discount on a drug assigned a Medicare negotiated price under CMS guidance. PhRMA anticipates the job will not be easy.
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
