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
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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
Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Milestone Pharmaceuticals said that it has initiated a Phase 3 clinical study of etripamil, an intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). Results from a Phase 2 study of etripamil were announced in May 2017, and in August of that year, the company said that it had raised $55 million for Phase 3 … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
Eurocine Vaccines said that results from a study of its Immunose Flu intranasal flu vaccine in adults aged 50-70 showed no serious adverse events and only minimal experiences of discomfort. The study, which took place during the 2017/18 flu season, enrolled 298 subjects at 5 locations in Sweden. The subjects, who had a mean age of 63, were divided into treatment … [Read more...] about Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
FDA advisory committee votes in favor of ALIS inhalation solution for patients with limited or no other treatment options
The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) voted against the efficacy and safety of Insmed's ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) for all patients but voted in favor of its efficacy and safety for patients with limited or no other … [Read more...] about FDA advisory committee votes in favor of ALIS inhalation solution for patients with limited or no other treatment options
FDA accepts NDA for Ryaltris, sets PDUFA date
The FDA has accepted Glenmark Pharmaceuticals' NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019, the company said. Glenmark announced submission of the NDA in May 2018. Positive results from Phase 3 studies of Ryaltris … [Read more...] about FDA accepts NDA for Ryaltris, sets PDUFA date
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
DFE Pharma announces improved supply of inhalation grade lactose
According to DFE Pharma, the company has significantly increased production capacities of its excipients, including all of its inhalation grade lactose products. The company said that it achieved the improved supply through investments at facilities in the Netherlands, Germany, and India. Inhalation grade lactose is produced at the plant in Veghel, the … [Read more...] about DFE Pharma announces improved supply of inhalation grade lactose
Cohero Health announces new management hires
Cohero Health has announced 5 new hires "to scale for growth and drive commercial sales of its BreatheSmart platform." In 2016, Cohero and H&T Presspart announced that they had partnered on development of an electronic inhaler called the eMDI. The new hires are: Amber Thompson, Chief Client Officer; Sergio Carbone, Chief Information and Technology Officer; Yury … [Read more...] about Cohero Health announces new management hires