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
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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
TFF Pharmaceuticals announces US patent for DPI particle technology
TFF Pharmaceuticals said that it has received a notice of allowance for US Patent Application No. 12/778,795, titled, "Compositions and Methods of Making Brittle-Matrix Particles Through Blister Pack Freezing," which covers technology related to the company's DPI products for respiratory conditions. Earlier this year, TFF announced that it had raised $14 million … [Read more...] about TFF Pharmaceuticals announces US patent for DPI particle technology
Seqirus gets rights to market Ryaltris nasal spray in Australia and New Zealand
Glenmark Pharmaceuticals has announced that it will receive an unspecified amount up front, plus regulatory and commercial milestone payments, from Seqirus for the rights to commercialize Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray in Australia and New Zealand. In December 2017, Glenmark announced positive results from a Phase 3 trial of … [Read more...] about Seqirus gets rights to market Ryaltris nasal spray in Australia and New Zealand