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
Business
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
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
Teva launches generic version of Perforomist inhalation solution in the US
Teva Pharmaceuticals said that it has launched a generic version of Perforomist formoterol fumarate inhalation solution for the treatment of COPD in the US. Perforomist was approved by the FDA in 2007; Teva first submitted an ANDA for its generic inhalation solution in 2009; the Teva ANDA was tentatively approved in May 2020; and Mylan's covering Perforomist expired … [Read more...] about Teva launches generic version of Perforomist inhalation solution in the US
Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada
Valeo Pharma has announced the launch of the Enerzair Breezhaler indacaterol / glycopyrronium / mometasone furoate and Atectura Breezhaler indacaterol / mometasone furoate DPIs in Canada. The company acquired Canadian rights to the two Novartis dry powder inhalers in March 2021. Enerzair (QVM149) and Atectura (QMF149) are also approved in Europe and in … [Read more...] about Valeo launches Enerzair Breezhaler and Atectura Breezhaler in Canada
Incannex signs agreement with Vectura for preclinical development of its inhaled CBD/isoflurane for the treatment of TBI
Inhalation CDMO Vectura has announced an agreement to provide preclinical development services for Incannex Healthcare's IHL-216A CBD/isoflurane, which Incannex is developing for the treatment of traumatic brain injury. In addition to performing screening, stability, and optimization studies, Vectura will manufacture the IHL-216A needed for toxicology studies. Monash … [Read more...] about Incannex signs agreement with Vectura for preclinical development of its inhaled CBD/isoflurane for the treatment of TBI
ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19
ENA Respiratory said that it has raised up to AU$32 million for development of its INNA-051 pegylated TLR2/6 agonist nasal spray for the prevention of respiratory viruses, including COVID-19, and plans to initiate a Phase 1 study of the nasal spray within a few weeks. In September 2020, the company announced a preclinical study demonstrated that INNA-051 reduced … [Read more...] about ENA Respiratory gets AU$32 million for development of INNA-051 antiviral nasal spray for COVID-19
Glenmark launches Tiogiva tiotropium DPI in the UK
Glenmark Pharmaceuticals has announced the launch of its Tiogiva tiotropium bromide DPI in the UK for the treatment of COPD. The company announced in August 2018 that it had acquired the rights to market the generic version of Spiriva Handihaler in Western Europe; the company also acquired the rights to market the Stalpex fluticasone/salmeterol DPI in Europe from … [Read more...] about Glenmark launches Tiogiva tiotropium DPI in the UK
Taiba gets rights to Arikayce in Gulf Cooperation Council countries
Taiba Middle East announced that it has acquired exclusive distribution and marketing rights to Insmed's Arikayce amikacin liposome inhalation suspension in Saudi Arabia, UAE, Kuwait, Oman, Qatar, and Bahrain, the six countries that make up the Gulf Cooperation Council. In the US, Arikayce has been approved for the treatment of nontuberculous mycobacterial (NTM) … [Read more...] about Taiba gets rights to Arikayce in Gulf Cooperation Council countries