December 2016
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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)… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe… Read more . . .
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