Levo Therapeutics announced that the FDA has accepted the company's NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with a decision about approval expected by the end of 2021. LV-101 for PWS was granted Fast Track designation by the FDA in 2019. … [Read more...] about NDA for Levo Therapeutics’ intranasal carbetocin for Prader-Willi syndrome gets priority review designation
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M8 Pharmaceuticals gets Brazilian and Mexican rights to Marinomed’s Carragelose nasal spray
M8 Pharmaceuticals said that it has acquired exclusive rights to market Marinomed's Carragelose nasal spray in Brazil and Mexico. The company will market the product in those countries as Barlo nasal spray for the prevention of respiratory viruses. Carragelose nasal sprays are currently marketed over 40 countries, including Italy, Austria, Canada, China, and … [Read more...] about M8 Pharmaceuticals gets Brazilian and Mexican rights to Marinomed’s Carragelose nasal spray
TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims
The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company's Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK Medicines and Healthcare products Regulatory Agency questioned claims regarding Viraleze, prompting the company's … [Read more...] about TGA fines Starpharma more than $93,000 over Viraleze nasal spray claims
Inhalation Sciences announces proof-of-concept project with new mouse exposure model
Inhalation Sciences (ISAB) announced that its CRO division, Inhalation Research Services (IRS), has signed an agreement with "an innovative US pharma company that is developing novel mRNA therapies for the treatment of cystic fibrosis and other pulmonary diseases" for a proof-of-concept project utilizing ISAB's PreciseInhale aerosol generating system. The … [Read more...] about Inhalation Sciences announces proof-of-concept project with new mouse exposure model
FluGen gets funding from US Department of Defense for intranasal flu vaccine
FluGen said that it has received an $11.4 million grant from the United States Department of Defense for a Phase 1b study to evaluate the ability of its M2SR intranasal flu vaccine to protect against a variety of flu strains, including those like H3N2 that are mismatched to current vaccines. In February 2019, FluGen announced that a Phase 2 trial of the M2SR vaccine … [Read more...] about FluGen gets funding from US Department of Defense for intranasal flu vaccine
Savara initiates new Phase 3 trial of molgramostim inhaled GM-CSF for aPAP
Savara has announced the initiation of the Phase 3 IMPALA-2 clinical trial of molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In December 2020, the company stopped development of the AeroVanc vancomycin DPI and Apulmiq (Linhaliq) inhaled … [Read more...] about Savara initiates new Phase 3 trial of molgramostim inhaled GM-CSF for aPAP
Altimmune halts development of AdCOVID intranasal vaccine, terminates trial of T-COVID intranasal therapeutic
Altimmune has discontinued development of its AdCOVID intranasal vaccine for the prevention of COVID-19 after the failure of a Phase 1 trial and has stopped enrollment in a Phase 1/2 trial of its T-COVID intranasal therapy for COVID-19 the company said. The FDA had cleared the IND for the Phase 1 trial of AdCOVID in February 2021; the Phase 1/2 trial of T-COVID was … [Read more...] about Altimmune halts development of AdCOVID intranasal vaccine, terminates trial of T-COVID intranasal therapeutic
Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals has announced the initiation of the AP-019 Phase 2 clinical trial of inhaled Ampion for the treatment of respiratory distress in patients with COVID-19. The company said that it has also received the okay from the FDA to add at least one trial site in India which currently has a high incidence of COVID-19; the initial location was in the US. … [Read more...] about Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients
Pieris announces development of inhaled anticalin for IPF, long COVID
Pieris Pharmaceuticals has announced that it will develop an inhaled anticalin known as PRS-220 for the treatment of idiopathic pulmonary fibrosis and for pulmonary fibrosis following COVID infection, with both programs slated to start in 2022. A €14.2 million grant from the Bavarian Ministry of Economic Affairs, Regional Development and Energy will fund development … [Read more...] about Pieris announces development of inhaled anticalin for IPF, long COVID
UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims
According to Starpharma, LloydsPharmacy has paused sales of Starpharma's Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned "promotional claims, including references to SARS-CoV-2 and COVID-19, and the interrelationship between these product claims and its categorization." The company … [Read more...] about UK sales of Starpharma’s Viraleze nasal spray paused after MHRA questions promotional claims