Auris Medical has announced the initiation of the Phase 2 TRAVERS trial of its AM-125 intranasal betahistine for the treatment of acute vertigo resulting from removal of a vestibular schwannoma. Auris is also developing intranasal betahistine for the treatment of obesity associated with Prader-Willi syndrome and said that it has completed enrollment in a Phase 1b … [Read more...] about Auris Medical initiates Phase 2 trial of intranasal betahistine for acute vertigo
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CHMP issues positive opinion regarding Inbrija
According to Acorda Therapeutics, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding Inbrija inhaled dry powder levodopa for the treatment of motor fluctuations (OFF periods) in Parkinson's disease patients treated with a levodopa/dopa-decarboxylase inhibitor. The marketing authorization … [Read more...] about CHMP issues positive opinion regarding Inbrija
Zambon acquires Breath Therapeutics
Italian pharmaceutical company Zambon announced that it has paid €140 million up front for Breath Therapeutics, which is developing L‑CsA‑i inhaled liposomal Cyclosporine A for the treatment of bronchiolitis obliterans syndrome (BOS). The deal includes regulatory and sales milestones that could bring the total up to €500 million. Breath Therapeutics is a spin off … [Read more...] about Zambon acquires Breath Therapeutics
FDA approves Lilly’s Baqsimi intranasal glucagon (updated)
The FDA has announced that it approved Eli Lilly and Company's Baqsimi single-use intranasal dry powder glucagon for the emergency treatment of severe hypoglycemia. Lilly announced that it had submitted the NDA for Baqsimi in July 2018. The company, which acquired worldwide rights to the nasal glucagon powder from Locemia in 2015, said at the time that it had also … [Read more...] about FDA approves Lilly’s Baqsimi intranasal glucagon (updated)
Oyster Point initiates Phase 3 trial of nasal spray for dry eye disease
Oyster Point Pharma has announced the initiation of the Phase 3 ONSET-2 study of its OC-01 nicotine acetylcholine receptor (nAChR) agonist nasal spray for the treatment of dry eye disease. In October 2018, the company announced positive Phase 2b results for both OC-01 and OC-02 nasal sprays for that indication. Earlier this year, Oyster Point said that it had raised … [Read more...] about Oyster Point initiates Phase 3 trial of nasal spray for dry eye disease
BlueWillow Biologics gets US patent for intranasal HSV vaccine
BlueWillow Biologics announced that it has been issued US patent No. 10,206,996, titled "Herpes simplex virus nanoemulsion vaccine," covering an intranasal herpes simplex virus (HSV) vaccine based on its NanoVax adjuvant platform. The company is developing the vaccine to protect against HSV-1 and HSV-2, which can cause genital herpes. According to the company, … [Read more...] about BlueWillow Biologics gets US patent for intranasal HSV vaccine
FDA issues final guidance on postmarket safety reports for combination products
The FDA has issued a final guidance titled "Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff" that specifies how to comply with postmarketing safety reporting (PMSR) requirements for combination products issued in 2016. The guidance cites several examples of combination product applicants subject to the rule, including "A … [Read more...] about FDA issues final guidance on postmarket safety reports for combination products
MVP says it expects to respond to clinical hold on Penthrox by early 2020
Penthrox methoxyflurane inhaler maker Medical Developments International said that it recently met with the FDA regarding the agency's August 2018 clinical hold letter on Penthrox, and the company now has a path forward to resolve the issues. Penthrox is already approved in Australia, Canada, and the majority of Europe. According to MVP, the FDA has dropped a … [Read more...] about MVP says it expects to respond to clinical hold on Penthrox by early 2020
EMA grants orphan drug designation to Aridis’ AR-501 inhaled gallium citrate
Aridis Pharmaceuticals said that the EMA has granted orphan drug designation to the company's AR-501 inhaled gallium citrate for the treatment of pulmonary infections in cystic fibrosis patients. The company said that the FDA had also recently granted orphan drug designation to AR-501, also known as "Panaecin," for that indication. A Phase 1/2a study of AR-501 is … [Read more...] about EMA grants orphan drug designation to Aridis’ AR-501 inhaled gallium citrate
Vectura focused on securing partners for development of inhaled drugs
In a business update, Vectura Group said that the company is focusing its R&D strategy on partnerships for development of its inhaled drug candidates. The company also said that it is considering how to structure a proposed £50 million return of capital which it expects to begin this year as a result of its "reducing R&D risk profile, future cash generation … [Read more...] about Vectura focused on securing partners for development of inhaled drugs