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Business

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

MannKind partners with Thirona on inhaled ALK-5 kinase inhibitor

MannKind Corporation will develop a dry powder formulation of Thirona Bio's FBM5712 ALK-5 kinase inhibitor, the companies have announced. The deal gives MannKind the option to license the compound for the treatment of fibrotic diseases in the lung and includes "a convertible promissory note purchase agreement to support Thirona’s Series A financing." ALK-5 kinase … [Read more...] about MannKind partners with Thirona on inhaled ALK-5 kinase inhibitor

Nuance Pharma acquires Chinese rights to Verona’s ensifentrine

Nuance Pharma will pay $25 million in cash, plus equity in its parent company Nuance Biotech valued at $15 million, as well as potential milestone payments worth up to $179 million to Verona Pharma for the rights to develop and market Verona's ensifentrine inhaled PDE3/PDE4 inhibitor in mainland China, Taiwan, Hong Kong and Macau. According to the announcement, Nuance … [Read more...] about Nuance Pharma acquires Chinese rights to Verona’s ensifentrine

Nuformix gets notice of allowance for US patent covering its inhaled tranilast

Nuformix said that it has received a Notice of Allowance for US Patent Application No. 17/051,592 titled, "Crystalline Tranilast Salts and Their Pharmaceutical Use." The company has already been granted one patent covering crystalline forms of tranilast. According to Nuformix, pre-clinical studies of its NXP002 tranilast, which it is developing as a potential inhaled … [Read more...] about Nuformix gets notice of allowance for US patent covering its inhaled tranilast

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