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Insmed confirms filing of MAA for Arikayce, announces new hires

In its announcement of fourth quarter and full year financial results for 2014, Insmed has confirmed that it filed an MAA for Arikayce liposomal amikacin inhalation solution. The company said that the EMA's Pediatric Committee has approved the Pediatric Investigation Plan for the product, and the MAA has subsequently been validated. Insmed also announced the … [Read more...] about Insmed confirms filing of MAA for Arikayce, announces new hires

TGA warns of smoking devices that look nearly identical to MDIs

Australia's Therapeutic Goods Administration (TGA) has issued a warning about devices marketed by a company called Discreet Vape that look nearly identical to metered dose inhalers used for rescue medications for asthma. The PUFFiT and PUFFiT-X devices are advertised as "the discreet choice" for smoking "dry herbal blends." Discreet Vape, based in Hong Kong, … [Read more...] about TGA warns of smoking devices that look nearly identical to MDIs

Newly launched Turing Pharmaceuticals to develop intranasal ketamine, Syntocinon

Several months after Retrophin announced that it would divest several of its pipeline products, including Syntocinon intranasal oxytocin and intranasal ketamine, to Turing Pharmaceuticals, the latter company has officially announced its launch. Turing Pharmaceuticals is headed by Martin Shkreli, who left Retrophin suddenly after reports of "stock trading … [Read more...] about Newly launched Turing Pharmaceuticals to develop intranasal ketamine, Syntocinon

Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution

A Phase 3 trial program of Sunovion Pharmaceutical's SUN-101 glycopyrrolate inhalation solution for the treatment of moderate-to-very severe COPD has begun enrolling patients, the company announced. The program includes three studies expected to enroll about 2,340 COPD patients. SUN-101 is delivered using PARI's eFlow nebulizer system and, if approved, would be the … [Read more...] about Sunovion initiates Phase 3 program for glycopyrrolate inhalation solution

Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat

Boehringer Ingelheim has presented data from five Phase 3 trials of tiotropium Respimat for the treatment of asthma at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The data come from two PrimoTinA-asthma trials (severe asthma), two MezzoTinA-asthma trials (moderate asthma), and a single GraziaTinA-asthma trial (mild asthma). … [Read more...] about Boehringer Ingelheim presents data from Phase 3 trials of tiotropium Respimat

Meda’s Dymista gets FDA approval for children aged 6-11

The FDA has approved Meda's Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 "who require treatment with both components," the company said. Dymista was approved for adults and for children 12 and older in 2012. Meda submitted data from two pediatric trials to support the … [Read more...] about Meda’s Dymista gets FDA approval for children aged 6-11

Aegis Therapeutics gets patent for intranasal formulations

Aegis Therapeutics has announced that the US Patent and Trademark Office has awarded the company US Patent No. 8,927,497, which covers a method "for non-invasive delivery of anti-seizure drugs via a simple metered nasal spray" based on the company's Intravail transmucosal absorption enhancement technology. The patent, titled "Absorption enhancers for intranasal … [Read more...] about Aegis Therapeutics gets patent for intranasal formulations