Intranasal vaccine developer AuraVax Therapeutics said that the company has licensed liposomal STING agonist technology from Massachusetts General Hospital (MGH) for use as an adjuvant in vaccines against COVID-19 and other respiratory diseases. The technology was developed by MGH researcher Mei X. Wu. AuraVax co-founder Navin Varadarajan commented, "We are … [Read more...] about AuraVax Therapeutics licences intranasal vaccine adjuvant technology from Massachusetts General Hospital
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Acorda sells Inbrija manufacturing operations to Catalent
Catalent will pay Acorda Therapeutics $80 million cash for Acorda's manufacturing operations in Chelsea, MA, USA where the company makes Inbrija dry powder levodopa. According to Catalent, the 90,000 sq ft CGMP facility "will act as a global center of excellence within the Catalent network for spray-dried dispersion and dry powder encapsulation and … [Read more...] about Acorda sells Inbrija manufacturing operations to Catalent
Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Receptor Life Sciences (RLS) said that a pre-IND meeting with the FDA "resulted in clear guidance on the regulatory requirements" for development of the company's RLS103 dry powder cannabidiol (CBD) for the treatment of panic attacks. The company is pursuing the 505(b)(2) pathway for approval of RLS103. In 2016, MannKind Corporation announced that it had licensed … [Read more...] about Receptor Life Sciences announces completion of pre-IND meeting for its CBD DPI for the treatment of panic attacks
Phase 1/2 trial of inhaled phage therapy for the treatment of P. aeruginosa infections in CF patients gets underway
According to Felix Biotechnology, Yale University researchers have initiated a Phase 1/2 trial of Felix's YPT-01 nebulized phage therapy for the treatment of chronic P. aeruginosa infections in cystic fibrosis patients. YPT-01 was initially formulated at Yale and licensed to Felix, a start-up founded by Yale Faculty. Felix recently signed a deal with TFF … [Read more...] about Phase 1/2 trial of inhaled phage therapy for the treatment of P. aeruginosa infections in CF patients gets underway
Ovoca Bio announces resubmission of marketing application for nasal spray for female sexual dysfunction in Russia
Ovoca Bio said that its subsidiary IVIX has resubmitted a marketing application for the company's BP-101 synthetic peptide nasal spray for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women to the Russian Ministry of Health (Minzdrav). The original application was submitted in September 2019, and Minzdrav rejected that application in … [Read more...] about Ovoca Bio announces resubmission of marketing application for nasal spray for female sexual dysfunction in Russia
Insmed initiates Phase 3b clinical trial of Arikayce inhalation suspension for the treatment of NTM caused by MAC
Insmed announced that the first patient has been dosed in a Phase 3b trial of its Arikayce amikacin liposome inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). Arikayce is delivered via the PARI Lamira nebulizer system. The FDA approved Arikayce for the treatment of NTM lung … [Read more...] about Insmed initiates Phase 3b clinical trial of Arikayce inhalation suspension for the treatment of NTM caused by MAC
Arcturus Therapeutics to develop inhaled CFTR mRNA therapy for CF
California-based Arcturus Therapeutics announced that it will develop its ARCT-032 aerosolized CFTR mRNA formulation for the treatment of cystic fibrosis. According to Arcturus, preclinical studies of ARCT-032, which is based on the company's LUNAR (lipid-enabled and unlocked nucleomonomer agent modified RNA) technology, have demonstrated that the inhaled therapy has … [Read more...] about Arcturus Therapeutics to develop inhaled CFTR mRNA therapy for CF
United Therapeutics to acquire priority review voucher for use with Tyvaso DPI NDA
United Therapeutics announced that it has agreed to pay $105 million for a rare pediatric disease priority review voucher that the company plans to use to get an 8-month FDA review of an NDA for its Tyvaso treprostinil DPI instead of the standard 12-month review. Submission of the NDA for the treatment of pulmonary arterial hypertension and pulmonary hypertension … [Read more...] about United Therapeutics to acquire priority review voucher for use with Tyvaso DPI NDA
FDA places clinical hold on Altimmune’s IND for AdCOVID
The FDA has issued a clinical hold on Altimmune's IND for its AdCOVID intranasal COVID-19 vaccine candidate, the company said. Altimmune submitted the IND to the agency in November 2020. According to the company, the FDA requested additional CMC data as well as changes to the protocols, and Altimmune has already responded to the clinical hold letter, which was … [Read more...] about FDA places clinical hold on Altimmune’s IND for AdCOVID
Menarini acquires rights to market Ryaltris nasal spray in 33 European countries
Menarini will pay Glenmark an undisclosed amount up front plus milestone payments for exclusive rights to market Ryaltris olopatadine/mometasone furoate nasal spray in 33 European countries, Ryaltris developer Glenmark has announced. Glenmark will be continue to be responsible for European development and regulatory approval of the nasal spray for the treatment of … [Read more...] about Menarini acquires rights to market Ryaltris nasal spray in 33 European countries