Regulatory Oversight and Compliance

Evolution of Aseptic Processing: INTERPHEX Keynote Part 3

November 17, 2021

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 2

November 16, 2021

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Evolution of Aseptic Processing: INTERPHEX Keynote Part 1

November 15, 2021

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

Califf Named to Head FDA

November 12, 2021

The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.

Generic-Drug Makers Also Fight Price Controls

November 12, 2021

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

EMA Grants Orphan Drug Designation to Rafael Pharmaceuticals’ CPI-613 (Devimistat)

November 12, 2021

European Medicines Agency (EMA) granted Rafael’s CPI-613 (devismat) an orphan drug designation for the treatment of refractory or relapsed Burkin’s lymphoma.

EMA Recommends Two COVID-19 Treatments

November 11, 2021

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

EMA Starts Evaluation of Moderna’s COVID-19 Vaccine for Children

November 10, 2021

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

FDA Approves Epilepsy and Migraine Treatment

November 09, 2021

EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.

EMA Begins Review of COVID-19 Treatment

November 09, 2021

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.