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
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Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy
Oyster Point Pharma has announced the initiation of the OLYMPIA Phase 2 clinical trial of its OC-01 varenicline nasal spray for the treatment of neurotrophic keratopathy. The company's NDA for OC-01 for the treatment of dry eye disease is currently under review by the FDA. The OLYMPIA study is expected to enroll approximately 100 patients with Stage 1 neurotrophic … [Read more...] about Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy
FDA approves Astepro nasal spray for nonprescription use
The FDA announced that it has approved Astepro azelastine hydrochloride nasal spray, 0.15%, for nonprescription use by adults and children aged 6 and older for the treatment of seasonal and perennial allergic rhinitis. Astepro Allergy will be the only antihistamine nasal spray for allergies available OTC in the US. The 0.1% strength, which includes pediatric … [Read more...] about FDA approves Astepro nasal spray for nonprescription use
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
FDA accepts Tyvaso DPI NDA for priority review
According to United Therapeutics and MannKind Corporation, the FDA has accepted United Therapeutics' NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics submitted the NDA in April 2021, and the agency is expected to complete the … [Read more...] about FDA accepts Tyvaso DPI NDA for priority review
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
MHRA approves Lupin’s generic of Fostair MDI
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Lupin's Luforbec beclometasone dipropionate / formoterol fumarate MDI, a generic version of Chiesi's Fostair MDI, for the treatment of asthma and COPD, the company said. Lupin Limited CEO Vinita Gupta said, "We are truly delighted to receive the first marketing authorization for generic … [Read more...] about MHRA approves Lupin’s generic of Fostair MDI
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