Regulatory Filings and Submissions

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.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.

Warp speed is amazoning pharma practices and protocols.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

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

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.

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

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

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

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

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.