Regulatory Filings and Submissions

The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.

FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.

SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

FDA has awarded Fast Track designation to Vivet Therapeutics’ novel gene therapy, VTX-801.

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.

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

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA has accepted Genetech’s BLA for faricimab, a bispecific antibody in development for treating wet age-related macular degeneration and diabetic macular edema.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.