Regulatory/GMP Compliance, Europe

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

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

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.

The MHRA has approved GW Pharmaceuticals’ Epidiolex for the treatment of seizures associated with tuberous sclerosis complex.

The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.

EMA’s Pharmacovigilance Risk Assessment Committee has requested more data for its evaluation of reports of Guillain-Barré syndrome after vaccination.

The agency’s Pharmacovigilance Risk Assessment Committee recommended updating the product information for Janssen’s COVID-19 vaccine to list immune thrombocytopenia as an adverse reaction.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.