United Therapeutics said that the FDA has issued a complete response letter regarding the company's NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil Technosphere from MannKind in September 2018 and submitted … [Read more...] about United Therapeutics gets CRL for its Tyvaso DPI NDA
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FDA approves Oyster Point’s Tyrvaya nasal spray for the treatment of dry eye disease
According to Oyster Point Pharma, the FDA has approved the company's Tyrvaya (OC-01) varenicline nasal spray for the treatment of dry eye disease, and Oyster Point expects to launch the nasal spray in November 2021. Oyster Point submitted the 505(b)(2) NDA for OC-01 in December 2020 and announced that the FDA accepted the NDA in March 2021. The company had previously … [Read more...] about FDA approves Oyster Point’s Tyrvaya nasal spray for the treatment of dry eye disease
Bayer and Meda file patent infringement suit after Apotex submits ANDA for generic of Astepro Allergy nasal spray
Bayer HealthCare and Meda Pharmaceuticals have filed a patent infringement suit against Apotex after Apotex submitted an ANDA for a generic version of Astepro Allergy azelastine hydrochloride nasal spray, 0.15%. The FDA approved Bayer's NDA for Astepro Allergy for non-prescription treatment of allergic rhinitis in June 2021. According to the complaint filed by Bayer … [Read more...] about Bayer and Meda file patent infringement suit after Apotex submits ANDA for generic of Astepro Allergy nasal spray
US PTAB finds that the majority of the claims in a Tyvaso patent challenged by Liquidia are unpatentable
According to Liquidia Corporation, an inter partes review by the US Patent Trial and Appeal Board (PTAB) regarding US Patent No. 9,604,901, which is listed in the Orange Book as one of 7 patents covering United Therapeutics' Tyvaso inhalation solution, determined that only 2 out of 9 claims included in the patent were potentially patentable based on a review of prior … [Read more...] about US PTAB finds that the majority of the claims in a Tyvaso patent challenged by Liquidia are unpatentable
Glenmark launches Tavulus tiotropium bromide DPI in Spain
Glenmark Pharmaceuticals has announced the launch of its version of Spiriva Handihaler tiotropium bromide DPI in Spain, where it will be known as Tavulus. In August 2018, Glenmark announced that it had acquired the rights to market the tiotropium dry powder inhaler in Western Europe. The company recently launched the tiotropium DPI in the UK, where it is called … [Read more...] about Glenmark launches Tavulus tiotropium bromide DPI in Spain
Phase 1 trial of IN-006 inhaled regdanvimab gets underway
Inhalon Biopharma and Celltrion have initiated a Phase 1 study of IN-006 inhaled regdanvimab, Inhalon said. The study is funded in part by a US Army contract worth $7 million. In July 2021, Inhalon and Celltrion announced that they had partnered to develop the nebulized "muco-trapping" formulation of regdanvimab for the treatment of COVID-19. Celltrion's intravenous … [Read more...] about Phase 1 trial of IN-006 inhaled regdanvimab gets underway
Pulmodyne partners with Alcove on manufacturing and distribution of the EZ-Spray atomization system
Pulmodyne and Alcove Manufacturing and Distribution have announced a new partnership for manufacturing and distribution of Alcove's EZ-Spray intranasal mucosal atomization device and said that Pulmodyne is set to begin manufacturing and distributing EZ-Spray devices by the end of 2021. The two companies also said that they also intend to develop new atomization … [Read more...] about Pulmodyne partners with Alcove on manufacturing and distribution of the EZ-Spray atomization system
American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery
The American Academy of Pediatrics (AAP) has issued a clinical report highlighting serious adverse events related to off-label use of OTC oxymetazoline nasal spray in children before and after surgery, noting that in these situations the drug "may be dosed without attention to the volume administered." The report cites recent cases of young children who suffered … [Read more...] about American Academy of Pediatrics highlights safety concerns related to the use of oxymetazoline nasal spray in pediatric surgery
Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis
According to Revelation Biosciences, the company has received clearance from an ethics committee for an Australian Phase 1b allergen challenge study of its REVTx-99 intranasal phosphorylated hexaacylated disaccharide (PHAD) for the treatment of allergic rhinitis and chronic nasal congestion. The trial, called RVL-CLR01, is expected to begin in the fourth quarter of … [Read more...] about Revelation Biosciences announces Phase 1b challenge study of its REVTx-99 intranasal PHAD for allergic rhinitis
Oncotelic Therapeutics to develop intranasal apomorphine
Oncotelic Therapeutics (formerly Mateon Therapeutics) announced that it has licensed an intranasal apomorphine formulation from Autotelic, Inc, a newly formed company owned largely by Oncotelic Chairman and CEO, Vuong Trieu. Oncotelic says that it plans to develop AL-101 nasal apomorphine for Parkinson's disease, erectile dysfunction, and female sexual dysfunction, … [Read more...] about Oncotelic Therapeutics to develop intranasal apomorphine