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
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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
Senzer announces plans to launch cannabidiol inhalation solution in UK
Senzer Ltd has announced plans to launch several inhaled cannabinoid products in the UK, beginning with its Cannafen cannabidiol inhalation solution later this year. Senzer is a subsidiary of Kind Consumer, whose Voke nicotine inhaler was approved by the MHRA for nicotine cessation in 2014. The company will launch the inhaled cannabinoid product under a specials … [Read more...] about Senzer announces plans to launch cannabidiol inhalation solution in UK
Menarini to market Orion DPIs in Asia-Pacific region
Menarini Asia-Pacific Holdings has signed a multi-year licensing agreement with Orion Corporation for distribution and commercialization of Easyhaler DPI products in China, Hong Kong, Philippines, Malaysia, Indonesia, Thailand, Singapore, Vietnam, Taiwan, and South Korea, the companies said. In 2016, Menarini and Orion announced that Menarini would co-market … [Read more...] about Menarini to market Orion DPIs in Asia-Pacific region
US appeals court affirms ruling on validity of Zomig nasal spray patents
Amneal Pharmaceuticals announced that the US Court of Appeals for the Federal Circuit has upheld a March 2017 ruling finding that Lannett infringed on US patents 6,750,237 and 7,220,767, which are related to Zomig zolmitriptan nasal spray. Impax Laboratories, an Amneal subsidiary, and AstraZeneca filed suit against Lannett after Lannett filed an ANDA for a generic … [Read more...] about US appeals court affirms ruling on validity of Zomig nasal spray patents
Lupin launches generic tobramycin inhalation solution in US
Lupin has launched its generic version of Tobi inhalation solution in the US, the company said. The FDA granted final approval of Lupin's ANDA for its tobramycin inhalation inhalation solution in March 2017. The 300 mg/5 ml inhalation solution is indicated for the treatment of P. aeruginosa lung infections in cystic fibrosis patients. Read the Lupin press … [Read more...] about Lupin launches generic tobramycin inhalation solution in US