Regulatory Oversight and Compliance

Califf Gains Bipartisan Support for FDA Confirmation

December 16, 2021

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

EMA Accepts MAA for Sanofi’s Rare Disease Therapy

December 16, 2021

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

FDA Approves American Regent’s Injectafer for Pediatric Patients

December 16, 2021

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

GSK and Vir Biotechnology’s Xevudy Gets Conditional Marketing Authorization from MHRA for COVID-19 Treatment

December 15, 2021

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

ISPE Publishes Guide for ATMP Facilities

December 10, 2021

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

EU Approves Roche’s Treatment for Severe COVID-19

December 08, 2021

Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.

FDA Grants Longeveron Orphan Drug Designation for Lomacel-B

December 08, 2021

Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.

Drug Costs Central Issue in Budget Battles

December 07, 2021

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

FDA Panel Recommends Merck’s COVID-19 Pill

December 06, 2021

Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.

Rituximab Plus Chemotherapy Approved by FDA for Select Pediatric Cancers

December 03, 2021

Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.