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Business

Perrigo gets US rights to OTC version of Nasonex nasal spray

Perrigo has licensed the US rights to an over-the-counter version of Merck's Nasonex mometasone furoate nasal spray, the company said. The company did not disclose the financial terms of the deal, which give Perrigo the right to seek regulatory approval, market, sell, and distribute the product. Nasonex, which was approved by the FDA in 1997, is currently … [Read more...] about Perrigo gets US rights to OTC version of Nasonex nasal spray

United Therapeutics grants Watson license for generic version of Tyvaso inhalation solution

United Therapeutics has announced a settlement agreement with Watson Laboratories that includes a license for Watson to manufacture and sell a generic version of Tyvaso treprostinil inhalation solution as of January 1, 2026. Watson is currently a subsidiary of Teva. The settlement resolves litigation that had been ongoing since Watson filed an ANDA for the … [Read more...] about United Therapeutics grants Watson license for generic version of Tyvaso inhalation solution

Recall of oxymetazoline nasal spray due to P. aeruginosa contamination

Florida-based Product Quest Manufacturing has recalled a lot of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa. The company said that it had not received reports of any adverse events but acknowledged that use of a nasal spray contaminated with P. aeruginosa could potentially lead to deadly … [Read more...] about Recall of oxymetazoline nasal spray due to P. aeruginosa contamination

New partnership formed for development of inhaled gene therapy for cystic fibrosis

Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC), Imperial Innovations, and Oxford BioMedica have formed a partnership for development of an inhaled therapy designed to introduce a healthy copy of the CFTR gene into lung cells. Boehringer Ingelheim will finance the development and has acquired the option to license exclusive global … [Read more...] about New partnership formed for development of inhaled gene therapy for cystic fibrosis

Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US

MannKind Corporation has signed an agreement with Tanner Pharma Group for distribution of Afrezza inhaled insulin in regions outside of the US, the company said. The agreement covers regions where Afrezza is not yet approved, and Tanner Pharma Group subsidiary TannerGAP will manage the distribution in those areas. In 2017, Mannkind announced that Biomm would … [Read more...] about Tanner Pharma Group subsidiary to distribute Afrezza inhaled insulin outside of US

Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development

Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a strategic advisor, the company said. The company also announced a public offering of common stock, with shares priced at $11.50 … [Read more...] about Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development

Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor

According to Adherium, the FDA has granted 510(k) clearance for OTC sales of the company's Hailie adherence monitoring sensor for use with several MDIs for the treatment of asthma. In March 2018, the FDA granted 510(k) clearance for OTC sales of the sensor for use with Symbicort; the new clearance covers use with ProAir HFA, Ventolin HFA, and Flovent HFA. The … [Read more...] about Adherium gets additional 510(k) clearance for OTC sales of Hailie inhaler monitoring sensor

Pneuma Respiratory raises $8.3 million

Pneuma Respiratory, which is developing a digital soft mist inhaler, announced that it has completed a Series A financing round that raised $8.3 million. The company's Pneumahaler device is a breath activated digital SMI that uses a cartridge system with a microfluidic spray ejector capable of delivering defined droplet sizes. The company said that its … [Read more...] about Pneuma Respiratory raises $8.3 million

3M DDS highlights addition of dose indicator on Proventil inhaler

3M Drug Delivery Systems has announced that its Proventil HFA albuterol MDI, which is marketed and distributed by Merck, now includes a top-mounted dose indicator. The FDA approved an sNDA for Proventil HFA with the dose indicator in September 2017, and Merck launched the new version of Proventil HFA in March 2018, according to 3M DDS. 3M Inhalation Drug … [Read more...] about 3M DDS highlights addition of dose indicator on Proventil inhaler

Hemomont opens nasal spray manufacturing facility in Montenegro

According to reports, Montenegrin pharmaceutical company Hemomont has officially opened a €5.3 million, 1,700 square meter nasal spray manufacturing facility in Podgorica that is expected to employ 30 people and produce 3 million units per month. Montenegrin President Milo Djukanovic attended the opening celebration. Hemomont is a subsidiary of Hemofarm, which is … [Read more...] about Hemomont opens nasal spray manufacturing facility in Montenegro

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