Finnish nanonization specialist Nanoform has announced the appointments of Eric Peter and Sergie Letser to the company’s US business development team. In January 2020, Nanoform announced the appointment of Sally Langa as its new Head of US Sales, and in February, the company announced that it had established a US subsidiary. Langa has since left the company. Peter … [Read more...] about Nanoform appoints US business development executives
News
MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
MediciNova said that it has tested a number of intranasal SARS-CoV-2 vaccine prototypes using a viral vector technology platform from Mie University and BioComo and has identified several candidates that it plans to advance. BioComo's BC-PIV vaccine carrier is based on recombinant human parainfluenza virus 2 (hPIV2) vectors. According to MediciNova, the intranasal … [Read more...] about MediciNova announces development plans for intranasal SARS-CoV-2 vaccine
Bilim Pharmaceuticals launches Ventofor Combi Fix, delivered by the PowdAir Plus DPI
H&T Presspart and Hovione Technology have revealed their collaboration with Bilim Pharmaceuticals on a dry powder inhaler based on the PowdAir Plus device. H&T Presspart acquired global rights to the capsule based DPI device from Hovione Technology in 2017. According to the announcement, Bilim has launched the Ventofor Combi Fix budesonide/formoterol DPI for … [Read more...] about Bilim Pharmaceuticals launches Ventofor Combi Fix, delivered by the PowdAir Plus DPI
MannKind appoints Kevin Kaiserman as VP, Medical Affairs and Safety
Inhaled drug company MannKind Corporation has announced the appointment of Kevin Kaiserman as VP, Medical Affairs and Safety. Kaiserman, a pedicatric endocrinologist, was most recently in private practice. The company markets Afrezza inhaled insulin, which was approved by the FDA in 2014, and is partnered with United Therapeutics on development of a treprostinil … [Read more...] about MannKind appoints Kevin Kaiserman as VP, Medical Affairs and Safety
FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays
Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder. The August 2020 revised product guidances include budesonide nasal spray and ketorolac tromethamine nasal spray. In … [Read more...] about FDA publishes product specific draft guidances for esketamine and sumatriptan nasal sprays
Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19
Partner Therapeutics (PTx) has announced the initiation of the iLeukPulm Phase 2 trial of an inhaled formulation of its Leukine sargramostim in hospitalized COVID-19 patients in respiratory distress. Partner recently signed a $35 million contract with the US Department of Defense for development of Leukine for the treatment of COVID-19. PTx acquired Leukine, a … [Read more...] about Partner Therapeutics initiates Phase 2 trial of inhaled sargramostim for COVID-19
Additional positive preclinical data for Altimmune’s AdCOVID intranasal COVID-19 vaccine
Altimmune has announced that a preclinical study of its intranasal COVID-19 vaccine candidate AdCOVID has demonstrated a strong immune response in the lungs of mice, particularly in the stimulation of CD8+ T cells. In July 2020, Altimmune reported that several studies in a mouse model demonstrated a strong IgG and IgA responses. Altimmune is partnered with the … [Read more...] about Additional positive preclinical data for Altimmune’s AdCOVID intranasal COVID-19 vaccine
Union Therapeutics announces successful completion of Phase 1 trial of niclosamide DPI
Union Therapeutics said that a Phase 1 SAD/MAD trial of UNI911 dry powder niclosamide in 44 healthy volunteers was completed successfully, confirming the safety of the inhaled formulation. The company recently acquired an option for rights to the dry powder formulation from TFF Pharmaceuticals and intends to develop it as a DPI for the treatment of COVID-19. Union … [Read more...] about Union Therapeutics announces successful completion of Phase 1 trial of niclosamide DPI
Virpax licenses Nanomerics’ MM2019 “molecular masking” nasal powder
Virpax Pharmaceuticals said that it has acquired exclusive North American rights to Nanomerics' MMS019 nasal powder, which it calls a "high density molecular masking spray" and which is intended to block viruses from taking hold in the respiratory tract. Virpax said that MMS019 is in preclinical development for the prevention of COVID-19, seasonal flu, and other … [Read more...] about Virpax licenses Nanomerics’ MM2019 “molecular masking” nasal powder
Lupin’s generic version of ProAir HFA approved by the FDA
The FDA has approved Lupin's generic version of Teva's ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India. Lupin CEO Vinita Gupta commented, “Approval of our generic albuterol MDI is a significant milestone in our complex generics evolution and a validation of … [Read more...] about Lupin’s generic version of ProAir HFA approved by the FDA