Regulatory Filings and Submissions

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

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

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

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.

The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.

Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.

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

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.

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 granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).

MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.

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.