Regulatory Filings and Submissions

The new draft guidance describes a standards recognition program for regenerative medicine therapies.

In the report, the agency presents the activities it accomplished in 2021 to protect and promote public health.

The European Commission has granted conditional marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for CARVYKTI (ciltacabtagene autoleucel), a cell therapy for treating multiple myeloma.

Roche has received approval from the European Commission for Lunsumio (mosunetuzumab), the first CD20xCD3 T-cell engaging bispecific antibody for treating follicular lymphoma.

Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

The final guidance addresses safety aspects of container and carton labeling design.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

FDA has revised the Emergency Use Authorization for sotrovimab.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.