Intranasal vaccines are showing promise, but there are multiple formulation hurdles to overcome.

Getting a Nose for Vaccines

The delivery platform depends on API-related factors, and the development stage of the product.

Platform Decisions for Inhalation Drugs

Topic

Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

Articles

It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings.

Determining Comparability of Biosimilars Through Statistical Approaches

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

FDA Grants Orphan Drug Designation to Aerami Therapeutics’s Imatinib

Signal Rx Pharmaceuticals, Crystec, and ADYA Consulting are collaborating on the development of an inhaled dry powder formulation of SF2523 to treat pulmonary fibrosis, lung cancer, and SARS-CoV-2 related illnesses.

Partnership Forms for Development of Inhalable Formulation to Treat Lung Cancer, Lung Fibrosis, and SARS-CoV-2 

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech

FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.

FDA Approves First HIF-2α Inhibitor Therapy in US

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

WHO’s Solidarity Plus Trial to Assess Three Drugs for Hospitalized COVID-19 Patients

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

FDA Approves Expanded Label for Lilly’s Lyumjev

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



CHMP Approves Manufacturing Scale-Up for Spikevax

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose

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

Dosage Forms

Getting a Nose for Vaccines

Platform Decisions for Inhalation Drugs